Trial Outcomes & Findings for Immunogenicity & Safety of GSK's Avian Flu Vaccine 1557484A Given to Adults Aged ≥18 Years (NCT NCT00719043)

NCT ID: NCT00719043

Last Updated: 2018-07-09

Results Overview

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 549. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

841 participants

Primary outcome timeframe

At Day 559

Results posted on

2018-07-09

Participant Flow

Study duration was of approximately 909 days for all subjects.

Participant milestones

Participant milestones
Measure	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F1-Placebo Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F2-Placebo Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Overall Study STARTED	120	121	119	119	122	120	120
Overall Study COMPLETED	88	96	99	96	95	86	92
Overall Study NOT COMPLETED	32	25	20	23	27	34	28

Reasons for withdrawal

Reasons for withdrawal
Measure	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F1-Placebo Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F2-Placebo Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Overall Study Adverse Event	5	1	2	2	1	4	4
Overall Study Lost to Follow-up	14	10	8	9	10	9	9
Overall Study Protocol Violation	0	0	0	0	0	1	0
Overall Study Other	1	0	1	2	0	2	1
Overall Study Withdrawal by Subject	12	14	9	10	16	18	14

Baseline Characteristics

Immunogenicity & Safety of GSK's Avian Flu Vaccine 1557484A Given to Adults Aged ≥18 Years

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F1-Placebo Group n=120 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F2-Placebo Group n=121 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group n=119 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group n=119 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group n=122 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group n=120 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group n=120 Participants Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.	Total n=841 Participants Total of all reporting groups
Age, Continuous	49.8 Years STANDARD_DEVIATION 18.01 • n=5 Participants	49.6 Years STANDARD_DEVIATION 17.93 • n=7 Participants	50.7 Years STANDARD_DEVIATION 17.67 • n=5 Participants	49.2 Years STANDARD_DEVIATION 17.75 • n=4 Participants	50.3 Years STANDARD_DEVIATION 17.77 • n=21 Participants	50.1 Years STANDARD_DEVIATION 18.92 • n=8 Participants	50.0 Years STANDARD_DEVIATION 18.03 • n=8 Participants	49.95 Years STANDARD_DEVIATION 17.99 • n=24 Participants
Sex: Female, Male Female	80 Participants n=5 Participants	73 Participants n=7 Participants	69 Participants n=5 Participants	70 Participants n=4 Participants	68 Participants n=21 Participants	70 Participants n=8 Participants	75 Participants n=8 Participants	505 Participants n=24 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	48 Participants n=7 Participants	50 Participants n=5 Participants	49 Participants n=4 Participants	54 Participants n=21 Participants	50 Participants n=8 Participants	45 Participants n=8 Participants	336 Participants n=24 Participants

PRIMARY outcome

Timeframe: At Day 559

Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus.

Outcome measures

Outcome measures
Measure	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group n=83 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group n=87 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group n=80 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group n=72 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.	71 Subjects	81 Subjects	73 Subjects	65 Subjects	—	—	—

PRIMARY outcome

Timeframe: At Day 192

Outcome measures

Outcome measures
Measure	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group n=99 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.	44 Subjects	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Days 549 and 559

HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.

Outcome measures

Outcome measures
Measure	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group n=83 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group n=88 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group n=81 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group n=72 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. A/turkey, Day 549 (N=83,88,81,72)	11.1 Titers Interval 8.8 to 14.1	8.3 Titers Interval 7.0 to 9.7	9.2 Titers Interval 7.6 to 11.2	11.4 Titers Interval 9.1 to 14.4	—	—	—
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. A/turkey, Day 559 (N= 83,88,81,72)	356.7 Titers Interval 265.9 to 478.5	266.4 Titers Interval 202.2 to 351.2	446.6 Titers Interval 336.0 to 593.7	343.9 Titers Interval 254.2 to 465.3	—	—	—

PRIMARY outcome

Timeframe: At Days 182 and 192

HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome concerns solely subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.

Outcome measures

Outcome measures
Measure	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group n=100 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. A/turkey strain, Day 182 (N=100)	10.8 Titers Interval 8.4 to 13.9	—	—	—	—	—	—
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. A/turkey strain, Day 192 (N=99)	43.5 Titers Interval 32.6 to 58.0	—	—	—	—	—	—

PRIMARY outcome

Timeframe: At Days 549 and 559

A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.

Outcome measures

Outcome measures
Measure	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group n=88 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group n=87 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group n=81 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group n=72 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. A/turkey, Day 549 (N=83,88,81,72)	15 Subjects	8 Subjects	10 Subjects	13 Subjects	—	—	—
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. A/turkey, Day 559 (N= 83,87,80,72)	79 Subjects	83 Subjects	77 Subjects	69 Subjects	—	—	—

PRIMARY outcome

Timeframe: At Days 182 and 192

Outcome measures

Outcome measures
Measure	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group n=100 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. A/turkey strain, Day 182 (N=100)	24 Subjects	—	—	—	—	—	—
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. A/turkey strain, Day 192 (N=99)	64 Subjects	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Within the 7-day (Days 0-6) post vaccination periods

Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccine for whom any post-vaccination data were available.

Assessed solicited local symptoms were pain, redness and swelling. Any was defined as an occurrence of the specified solicited local symptom regardless of its intensity.

Outcome measures

Outcome measures
Measure	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group n=120 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group n=121 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group n=119 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group n=119 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group n=122 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group n=120 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group n=120 Participants Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Number of Subjects With Solicited Local Symptoms Any Pain	98 Subjects	100 Subjects	101 Subjects	93 Subjects	102 Subjects	90 Subjects	95 Subjects
Number of Subjects With Solicited Local Symptoms Any Redness	8 Subjects	4 Subjects	12 Subjects	9 Subjects	14 Subjects	4 Subjects	8 Subjects
Number of Subjects With Solicited Local Symptoms Any Swelling	6 Subjects	7 Subjects	15 Subjects	4 Subjects	16 Subjects	9 Subjects	11 Subjects

PRIMARY outcome

Timeframe: Within the 7-day (Days 0-6) post vaccination periods

Solicited general symptoms assessed were fatigue, headache, joint pain at other locations (joint pain), muscle aches, shivering, sweating and fever. Any was defined as an occurrence of the specified solicited general symptom, irrespective of its intensity or relationship to vaccination. Any fever was defined as oral temperature higher than or equal to (≥) 38.0 degrees Celsius (°C).

Outcome measures

Outcome measures
Measure	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group n=120 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group n=121 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group n=119 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group n=119 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group n=122 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group n=120 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group n=120 Participants Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Number of Subjects With Solicited General Symptoms Any Fatigue	45 Subjects	50 Subjects	47 Subjects	44 Subjects	42 Subjects	39 Subjects	47 Subjects
Number of Subjects With Solicited General Symptoms Any Headache	44 Subjects	50 Subjects	42 Subjects	44 Subjects	44 Subjects	35 Subjects	47 Subjects
Number of Subjects With Solicited General Symptoms Any Joint pain	33 Subjects	37 Subjects	36 Subjects	26 Subjects	28 Subjects	16 Subjects	30 Subjects
Number of Subjects With Solicited General Symptoms Any Muscle aches	54 Subjects	52 Subjects	59 Subjects	49 Subjects	48 Subjects	42 Subjects	55 Subjects
Number of Subjects With Solicited General Symptoms Any Shivering	12 Subjects	18 Subjects	16 Subjects	8 Subjects	20 Subjects	10 Subjects	18 Subjects
Number of Subjects With Solicited General Symptoms Any Sweating	15 Subjects	20 Subjects	15 Subjects	11 Subjects	14 Subjects	10 Subjects	11 Subjects
Number of Subjects With Solicited General Symptoms Any Fever	2 Subjects	5 Subjects	6 Subjects	3 Subjects	8 Subjects	2 Subjects	2 Subjects

PRIMARY outcome

Timeframe: From Day 0 to Day 909

MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s).

Outcome measures

Outcome measures
Measure	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group n=120 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group n=121 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group n=119 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group n=119 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group n=122 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group n=120 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group n=120 Participants Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Number of Subjects With Medically-attended Adverse Events (MAEs)	68 Subjects	66 Subjects	77 Subjects	75 Subjects	62 Subjects	63 Subjects	70 Subjects

PRIMARY outcome

Timeframe: Within the 43-day (Days 0-42) post-vaccination periods

An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and 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 was defined as any occurrence of an unsolicited AE in a subject, regardless of intensity grade or relation to vaccination.

Outcome measures

Outcome measures
Measure	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group n=120 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group n=121 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group n=119 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group n=119 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group n=122 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group n=120 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group n=120 Participants Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Number of Subjects With Unsolicited Adverse Events (AEs)	70 Subjects	72 Subjects	78 Subjects	68 Subjects	67 Subjects	68 Subjects	75 Subjects

PRIMARY outcome

Timeframe: From Day 0 to Day 909

A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as an occurrence of an SAE, regardless its relationship to vaccination.

Outcome measures

Outcome measures
Measure	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group n=120 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group n=121 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group n=119 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group n=119 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group n=122 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group n=120 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group n=120 Participants Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Number of Subjects With Serious Adverse Events (SAEs)	12 Subjects	14 Subjects	11 Subjects	9 Subjects	11 Subjects	15 Subjects	12 Subjects

SECONDARY outcome

Timeframe: At Day 192

Outcome measures

Outcome measures
Measure	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group n=99 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.	44 Subjects	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At Days 182 and 192

HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.

Outcome measures

Outcome measures
Measure	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group n=95 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group n=92 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey Virus Strain. A/turkey, Day 182 (N=95,92)	17.6 Titers Interval 13.1 to 23.6	12.2 Titers Interval 9.7 to 15.4	—	—	—	—	—
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey Virus Strain. A/turkey, Day 192 (N=94,86)	308.4 Titers Interval 231.1 to 411.5	374.4 Titers Interval 297.9 to 470.5	—	—	—	—	—

SECONDARY outcome

Timeframe: At Days 182 and 192

A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.

Outcome measures

Outcome measures
Measure	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group n=95 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group n=92 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. A/turkey, Day 182 (N=95,92)	30 Subjects	25 Subjects	—	—	—	—	—
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. A/turkey, Day 192 (N=94,86)	89 Subjects	85 Subjects	—	—	—	—	—

SECONDARY outcome

Timeframe: At Day 224

A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.

Outcome measures

Outcome measures
Measure	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group n=89 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group n=86 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group n=98 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.	82 Subjects	82 Subjects	60 Subjects	—	—	—	—

SECONDARY outcome

Timeframe: At Day 591

Outcome measures

Outcome measures
Measure	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group n=82 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group n=88 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group n=80 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group n=71 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.	77 Subjects	83 Subjects	75 Subjects	67 Subjects	—	—	—

SECONDARY outcome

Timeframe: At Days 192 and 224

GMFR was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the baseline reciprocal HI titer. Baseline for this outcome measure corresponds to Day 182. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.

Outcome measures

Outcome measures
Measure	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group n=94 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group n=86 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group n=99 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Geometric Mean Fold Rise (GMFR) as Regards Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain A/turkey, Day 192 (N=94,86,99)	17.8 Fold increase Interval 12.0 to 26.2	30.2 Fold increase Interval 22.2 to 41.2	4.0 Fold increase Interval 2.9 to 5.5	—	—	—	—
Geometric Mean Fold Rise (GMFR) as Regards Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain A/turkey, Day 224 (N=89,86,98)	11.2 Fold increase Interval 7.8 to 16.3	17.2 Fold increase Interval 12.9 to 23.0	4.2 Fold increase Interval 3.0 to 5.7	—	—	—	—

SECONDARY outcome

Timeframe: At Day 559

GMFR was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the baseline reciprocal HI titer. Baseline for this outcome measure corresponds to Day 549. This outcome measure solely concerns subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.

Outcome measures

Outcome measures
Measure	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group n=83 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group n=88 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group n=80 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group n=72 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group n=81 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Geometric Mean Fold Rise (GMFR) as Regards Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain A/turkey, Day 559 (N=83,87,80,72,81)	32.0 Fold increase Interval 21.9 to 46.8	32.0 Fold increase Interval 23.4 to 43.7	48.1 Fold increase Interval 34.6 to 66.9	30.1 Fold increase Interval 21.0 to 43.0	19.5 Fold increase Interval 13.4 to 28.4	—	—
Geometric Mean Fold Rise (GMFR) as Regards Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain A/turkey, Day 591 (N=82,88,80,71,81)	26.7 Fold increase Interval 18.4 to 38.7	29.1 Fold increase Interval 21.3 to 39.9	35.2 Fold increase Interval 25.4 to 48.8	22.0 Fold increase Interval 15.8 to 30.7	14.8 Fold increase Interval 10.4 to 21.2	—	—

SECONDARY outcome

Timeframe: At Day 591

Outcome measures

Outcome measures
Measure	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group n=82 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group n=88 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group n=80 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group n=71 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.	69 Subjects	80 Subjects	70 Subjects	61 Subjects	—	—	—

SECONDARY outcome

Timeframe: At Day 224

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 182. This outcome measure solely concerns subjects in the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.

Outcome measures

Outcome measures
Measure	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group n=89 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group n=86 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group n=98 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain.	64 Subjects	75 Subjects	42 Subjects	—	—	—	—

SECONDARY outcome

Timeframe: At Days 0, 182,192, 224, 549 and 729

Population: The analysis was performed on the Day 729 According-to-Protocol cohort for immunogenicity, i.e., all evaluable subjects with at least Day 182 and 192 or Day 549 and 559 haemagglutination inhibition (HI) titer results for the A/turkey/Turkey/1/05 virus), as well as with HI titers results available up to the Day 729 time point, for any virus strain.

HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure concerns solely the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.

Outcome measures

Outcome measures
Measure	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group n=95 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group n=92 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. A/turkey, Day 0 (N= 95,92)	9.2 Titers Interval 7.4 to 11.4	6.6 Titers Interval 5.7 to 7.7	—	—	—	—	—
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. A/turkey, Day 182 (N=95,92)	17.6 Titers Interval 13.1 to 23.6	12.2 Titers Interval 9.7 to 15.4	—	—	—	—	—
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. A/turkey, Day 192 (N=94,86)	308.4 Titers Interval 231.1 to 411.5	374.4 Titers Interval 297.9 to 470.5	—	—	—	—	—
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. A/turkey, Day 224 (N=93,91)	195.0 Titers Interval 146.7 to 259.1	213.7 Titers Interval 170.7 to 267.5	—	—	—	—	—
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. A/turkey, Day 549 (N=84,81)	32.7 Titers Interval 24.4 to 43.6	28.7 Titers Interval 22.6 to 36.5	—	—	—	—	—
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. A/turkey, Day 729 (N=78,78)	41.8 Titers Interval 32.1 to 54.4	31.2 Titers Interval 24.8 to 39.2	—	—	—	—	—

SECONDARY outcome

Timeframe: At Days 0, 182, 549, 559, 591 and 729

HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure concerns solely the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.

Outcome measures

Outcome measures
Measure	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group n=90 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group n=96 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group n=99 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group n=89 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. A/turkey, Day 0 (N=90,96,99,89)	8.0 Titers Interval 6.6 to 9.8	7.1 Titers Interval 6.0 to 8.3	6.6 Titers Interval 5.7 to 7.6	6.9 Titers Interval 5.9 to 8.0	—	—	—
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. A/turkey, Day 182 (N=90,96,99,89)	13.5 Titers Interval 10.3 to 17.8	10.8 Titers Interval 8.4 to 13.9	12.8 Titers Interval 10.0 to 16.4	13.7 Titers Interval 10.6 to 17.7	—	—	—
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. A/turkey, Day 549 (N=83,86,81,72)	11.1 Titers Interval 8.8 to 14.1	8.4 Titers Interval 7.1 to 9.9	9.2 Titers Interval 7.6 to 11.2	11.4 Titers Interval 9.1 to 14.4	—	—	—
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. A/turkey, Day 559 (N=83,85,80,72)	356.7 Titers Interval 265.9 to 478.5	266.4 Titers Interval 202.2 to 350.9	446.6 Titers Interval 336.0 to 593.7	343.9 Titers Interval 254.2 to 465.3	—	—	—
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. A/turkey, Day 591 (N=82,86,80,71)	300.3 Titers Interval 225.6 to 399.7	242.4 Titers Interval 182.8 to 321.5	326.9 Titers Interval 241.6 to 442.2	254.4 Titers Interval 188.5 to 343.3	—	—	—
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. A/turkey, Day 729 (N=81,83,79,70)	119.2 Titers Interval 95.3 to 149.0	96.6 Titers Interval 75.1 to 124.2	134.8 Titers Interval 106.4 to 170.9	105.6 Titers Interval 84.1 to 132.6	—	—	—

SECONDARY outcome

Timeframe: At Days 0, 182, 192, 224, 549, 559, 591 and 729

HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome measure concerns solely the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.

Outcome measures

Outcome measures
Measure	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group n=99 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. A/turkey, Day 0 (N=99)	8.0 Titers Interval 6.6 to 9.7	—	—	—	—	—	—
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. A/turkey, Day 182 (N=99)	10.6 Titers Interval 8.2 to 13.6	—	—	—	—	—	—
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. A/turkey, Day 192 (N=98)	43.4 Titers Interval 32.5 to 58.0	—	—	—	—	—	—
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. A/turkey, Day 224 (N=98)	43.7 Titers Interval 32.1 to 59.5	—	—	—	—	—	—
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. A/turkey, Day 549 (N=81)	15.6 Titers Interval 12.0 to 20.2	—	—	—	—	—	—
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. A/turkey, Day 559 (N=80)	314.4 Titers Interval 229.5 to 430.8	—	—	—	—	—	—
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. A/turkey, Day 591 (N=80)	236.2 Titers Interval 172.3 to 323.8	—	—	—	—	—	—
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. A/turkey, Day 729 (N=80)	98.1 Titers Interval 76.4 to 125.9	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At Days 0, 182,192, 224, 549 and 729

A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure concerns solely the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.

Outcome measures

Outcome measures
Measure	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group n=95 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group n=92 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain. A/turkey, Day 0 (N= 95,92)	16 Subjects	7 Subjects	—	—	—	—	—
Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain. A/turkey, Day 182 (N=95,92)	30 Subjects	25 Subjects	—	—	—	—	—
Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain. A/turkey, Day 192 (N=94,86)	89 Subjects	85 Subjects	—	—	—	—	—
Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain. A/turkey, Day 224 (N=93,91)	86 Subjects	87 Subjects	—	—	—	—	—
Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain. A/turkey, Day 549 (N=84,81)	42 Subjects	40 Subjects	—	—	—	—	—
Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain. A/turkey, Day 729 (N=78,78)	47 Subjects	49 Subjects	—	—	—	—	—

SECONDARY outcome

Timeframe: At Days 0, 182, 549, 559, 591 and 729

A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome measure concerns solely the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.

Outcome measures

Outcome measures
Measure	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group n=90 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group n=96 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group n=99 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group n=89 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain A/turkey, Day 0 (N=90,96,99,89)	11 Subjects	8 Subjects	8 Subjects	6 Subjects	—	—	—
Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain A/turkey, Day 182 (N=90,96,99,89)	25 Subjects	20 Subjects	28 Subjects	31 Subjects	—	—	—
Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain A/turkey, Day 549 (N=83,86,81,72)	15 Subjects	8 Subjects	10 Subjects	13 Subjects	—	—	—
Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain A/turkey, Day 559 (N=83,85,80,72)	79 Subjects	81 Subjects	77 Subjects	69 Subjects	—	—	—
Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain A/turkey, Day 591 (N=82,86,80,71)	77 Subjects	82 Subjects	75 Subjects	67 Subjects	—	—	—
Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain A/turkey, Day 729 (N=81,83,79,70)	75 Subjects	73 Subjects	71 Subjects	66 Subjects	—	—	—

SECONDARY outcome

Timeframe: At Days 0, 182, 192, 224, 549, 559, 591 and 729

Outcome measures

Outcome measures
Measure	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group n=99 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain A/turkey, Day 0 (N=99)	8 Subjects	—	—	—	—	—	—
Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain A/turkey, Day 182 (N=99)	23 Subjects	—	—	—	—	—	—
Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain A/turkey, Day 192 (N=98)	63 Subjects	—	—	—	—	—	—
Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain A/turkey, Day 224 (N=98)	59 Subjects	—	—	—	—	—	—
Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain A/turkey, Day 549 (N=81)	21 Subjects	—	—	—	—	—	—
Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain A/turkey, Day 559 (N=80)	76 Subjects	—	—	—	—	—	—
Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain A/turkey, Day 591 (N=80)	73 Subjects	—	—	—	—	—	—
Number of Subjects Seroprotected for HI Antibodies Against the A/Turkey/Turkey/1/2005 Virus Strain A/turkey, Day 729 (N=80)	70 Subjects	—	—	—	—	—	—

SECONDARY outcome

Timeframe: At Days 0, 10, 42, 182 and 549

HI antibody titers against the A/Indo virus strain were expressed as geometric mean titers (GMTs). This outcome measure solely concerns the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo and Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo groups.

Outcome measures

Outcome measures
Measure	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group n=95 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group n=92 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. A/Indo, Day 0 (N=95,92)	6.7 Titers Interval 5.7 to 7.9	5.9 Titers Interval 5.4 to 6.5	—	—	—	—	—
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. A/Indo, Day 10 (N=95,92)	32.3 Titers Interval 23.5 to 44.4	30.7 Titers Interval 23.4 to 40.4	—	—	—	—	—
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. A/Indo, Day 42 (N=93,88)	44.1 Titers Interval 32.4 to 59.9	44.8 Titers Interval 34.7 to 57.9	—	—	—	—	—
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. A/Indo, Day 182 (N=95,92)	22.4 Titers Interval 16.7 to 30.0	15.7 Titers Interval 12.3 to 20.0	—	—	—	—	—
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. A/Indo, Day 549 (N=84,81)	24.0 Titers Interval 17.3 to 33.2	22.7 Titers Interval 17.6 to 29.4	—	—	—	—	—

SECONDARY outcome

Timeframe: At Days 0, 10, 42, 182, 549 and 559

HI antibody titers against the A/Indo virus strain were expressed as geometric mean titers (GMTs). This outcome measure solely concerns the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.

Outcome measures

Outcome measures
Measure	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group n=90 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group n=96 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group n=99 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group n=89 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group n=99 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. A/Indo, Day 0 (N=90,96,99,89,99)	5.9 Titers Interval 5.4 to 6.5	5.7 Titers Interval 5.3 to 6.2	5.7 Titers Interval 5.1 to 6.3	5.6 Titers Interval 5.1 to 6.1	5.9 Titers Interval 5.3 to 6.5	—	—
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. A/Indo, Day 10 (N=89,95,98,87,97)	27.0 Titers Interval 19.4 to 37.6	17.2 Titers Interval 13.2 to 22.3	31.7 Titers Interval 24.2 to 41.4	26.2 Titers Interval 19.2 to 35.8	6.3 Titers Interval 5.6 to 7.1	—	—
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. A/Indo, Day 42 (N=87,94,96,87,97)	37.5 Titers Interval 27.9 to 50.4	27.3 Titers Interval 21.0 to 35.4	45.7 Titers Interval 35.0 to 59.7	36.6 Titers Interval 27.1 to 49.5	6.2 Titers Interval 5.5 to 7.0	—	—
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. A/Indo, Day 182 (N=90,96,99,89,99)	16.4 Titers Interval 12.5 to 21.6	13.7 Titers Interval 10.8 to 17.5	17.8 Titers Interval 14.0 to 22.6	16.2 Titers Interval 12.5 to 21.1	6.7 Titers Interval 5.8 to 7.7	—	—
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. A/Indo, Day 549 (N=83,86,81,72,81)	8.1 Titers Interval 6.6 to 10.0	7.9 Titers Interval 6.7 to 9.4	7.8 Titers Interval 6.5 to 9.3	9.2 Titers Interval 7.4 to 11.3	6.2 Titers Interval 5.5 to 6.9	—	—
Haemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/5/05 (A/Indo) Virus Strain. A/Indo, Day 559 (N=83,85,81,72,80)	304.3 Titers Interval 232.4 to 398.5	231.9 Titers Interval 177.1 to 303.5	376.6 Titers Interval 285.2 to 497.2	289.2 Titers Interval 215.8 to 387.7	113.1 Titers Interval 82.4 to 155.3	—	—

SECONDARY outcome

Timeframe: At Day 0, Day 10, Day 42, Day 182 and Day 549

Outcome measures

Outcome measures
Measure	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group n=95 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group n=92 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group n=99 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. A/Indo, Day 0 (N=95,92)	6 Subjects	6.7 Subjects	2 Subjects	—	—	—	—
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. A/Indo, Day 10 (N=95,92)	50 Subjects	32.3 Subjects	4 Subjects	—	—	—	—
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. A/Indo, Day 42 (N=93,88)	57 Subjects	44.1 Subjects	3 Subjects	—	—	—	—
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. A/Indo, Day 182 (N=95,92)	42 Subjects	22.4 Subjects	9 Subjects	—	—	—	—
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. A/Indo, Day 549 (N=84,81)	38 Subjects	24.0 Subjects	2 Subjects	—	—	—	—

SECONDARY outcome

Timeframe: At Day 0, Day 10, Day 42, Day 182, Day 549, and Day 559

A seroprotected subject was defined as a vaccinated subject with HI antibody reciprocal titers against the A/Indo virus strain greater than or equal to (≥) 1:40. This outcome measure solely concerns the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2, and Naïve Placebo-A/turkey H5N1-Formulation 3 groups.

Outcome measures

Outcome measures
Measure	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group n=90 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group n=96 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group n=99 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group n=89 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group n=99 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. A/Indo, Day 0 (N=90,96,99,89,99)	1 Subjects	0 Subjects	3 Subjects	2 Subjects	2 Subjects	—	—
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. A/Indo, Day 10 (N=89,95,98,87,97)	41 Subjects	36 Subjects	56 Subjects	44 Subjects	4 Subjects	—	—
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. A/Indo, Day 42 (N=87,94,96,87,97)	50 Subjects	51 Subjects	68 Subjects	53 Subjects	3 Subjects	—	—
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. A/Indo, Day 182 (N=90,96,99,89,99)	28 Subjects	29 Subjects	35 Subjects	32 Subjects	9 Subjects	—	—
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. A/Indo, Day 549 (N=83,86,81,72,81)	9 Subjects	9 Subjects	7 Subjects	11 Subjects	2 Subjects	—	—
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/Indonesia/5/05 (A/Indo) Virus Strain. A/Indo, Day 559 (N=83,85,81,72,80)	79 Subjects	80 Subjects	77 Subjects	68 Subjects	68 Subjects	—	—

SECONDARY outcome

Timeframe: At Days 10 and 42

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 0. This outcome measure only concerns the Pumarix Primed-A/turkey H5N1-Formulation 1-Placebo, Pumarix Primed-A/turkey H5N1-Formulation 2-Placebo, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.

Outcome measures

Outcome measures
Measure	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group n=95 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group n=92 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group n=89 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group n=97 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group n=98 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group n=87 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Number of Seroconverted Subjects for HI Antibodies Against the A/Indo Virus Strain. A/Indo, Day 10 (N=95,92,89,97,98,87)	42 Subjects	50 Subjects	38 Subjects	33 Subjects	52 Subjects	40 Subjects	—
Number of Seroconverted Subjects for HI Antibodies Against the A/Indo Virus Strain. A/Indo, Day 42 (N=93,88,87,96,96,87)	50 Subjects	61 Subjects	49 Subjects	51 Subjects	64 Subjects	51 Subjects	—

SECONDARY outcome

Timeframe: At Days 192 and 224

Outcome measures

Outcome measures
Measure	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group n=47 Participants Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Pumarix™ vaccine formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Pumarix™ and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549.Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Number of Seroconverted Subjects for HI Antibodies Against the A/Indo Virus Strain. A/Indo, Day 192	8 Subjects	—	—	—	—	—	—
Number of Seroconverted Subjects for HI Antibodies Against the A/Indo Virus Strain. A/Indo, Day 224	3 Subjects	—	—	—	—	—	—

Adverse Events

A/Indonesia Primed-A/Turkey Influenza (H5N1)-F1-Placebo Group

Serious events: 12 serious events

Other events: 106 other events

Deaths: 0 deaths

A/Indonesia Primed-A/Turkey Influenza (H5N1)-F2-Placebo Group

Serious events: 14 serious events

Other events: 109 other events

Deaths: 0 deaths

A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group

Serious events: 11 serious events

Other events: 106 other events

Deaths: 0 deaths

A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group

Serious events: 9 serious events

Other events: 103 other events

Deaths: 0 deaths

A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group

Serious events: 11 serious events

Other events: 106 other events

Deaths: 0 deaths

A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group

Serious events: 15 serious events

Other events: 101 other events

Deaths: 0 deaths

Naïve Placebo-A/Turkey H5N1-Formulation 3 Group

Serious events: 12 serious events

Other events: 106 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F1-Placebo Group n=120 participants at risk Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F2-Placebo Group n=121 participants at risk Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group n=119 participants at risk Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group n=119 participants at risk Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group n=122 participants at risk Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group n=120 participants at risk Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group n=120 participants at risk Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.84% 1/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Infections and infestations Pneumonia	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.84% 1/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Infections and infestations Appendicitis	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.84% 1/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Nervous system disorders Cerebrovascular accident	1.7% 2/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.82% 1/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Gastrointestinal disorders Pancreatitis	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.84% 1/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Cardiac disorders Bradycardia	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.84% 1/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Infections and infestations Bronchitis	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.82% 1/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
General disorders Chest discomfort	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Cardiac disorders Coronary artery disease	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.84% 1/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Reproductive system and breast disorders Endometriosis	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Nervous system disorders Loss of consciousness	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Renal and urinary disorders Nephrolithiasis	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	1.6% 2/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Nervous system disorders Syncope	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.84% 1/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous incomplete	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.82% 1/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Nervous system disorders Amnesia	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Immune system disorders Anaphylactic shock	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Cardiac disorders Angina pectoris	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.82% 1/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Vascular disorders Arteriosclerosis	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Cardiac disorders Arteriosclerosis coronary artery	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Cardiac disorders Atrial fibrillation	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Psychiatric disorders Bipolar disorder	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.84% 1/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma recurrent	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.84% 1/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer in situ	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.82% 1/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer recurrent	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.82% 1/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Cardiac disorders Cardiac failure congestive	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Nervous system disorders Carotid artery stenosis	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Infections and infestations Cellulitis gangrenous	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.84% 1/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Hepatobiliary disorders Cholecystitis	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.84% 1/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Gastrointestinal disorders Colitis	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Psychiatric disorders Completed suicide	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Cardiac disorders Coronary artery occlusion	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.82% 1/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Vascular disorders Deep vein thrombosis	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Metabolism and nutrition disorders Dehydration	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Psychiatric disorders Delirium	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Psychiatric disorders Drug abuse	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Gastrointestinal disorders Dyspepsia	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Cardiac disorders Endocarditis noninfective	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Musculoskeletal and connective tissue disorders Exostosis	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Infections and infestations Gastroenteritis salmonella	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Gastrointestinal disorders Haemorrhoids	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Injury, poisoning and procedural complications Head injury	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Vascular disorders Hypertensive crisis	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.82% 1/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Musculoskeletal and connective tissue disorders Intervertebral disc disorder	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.82% 1/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Musculoskeletal and connective tissue disorders Iron deficiency anaemia	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.84% 1/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.84% 1/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma metastatic	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Blood and lymphatic system disorders Lymphadenitis	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.84% 1/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.82% 1/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
General disorders Mass	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Infections and infestations Meningitis viral	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.84% 1/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Cardiac disorders Mitral valve disease	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Injury, poisoning and procedural complications Multiple fractures	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.84% 1/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Cardiac disorders Myocardial infarction	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.84% 1/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian adenoma	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.84% 1/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Reproductive system and breast disorders Ovarian cyst	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Injury, poisoning and procedural complications Overdose	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
General disorders Pain	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.82% 1/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Gastrointestinal disorders Pancreatic mass	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Gastrointestinal disorders Pancreatic pseudocyst	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid tumour benign	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Injury, poisoning and procedural complications Patella fracture	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Reproductive system and breast disorders Pelvic pain	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Injury, poisoning and procedural complications Post procedural complication	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.84% 1/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Infections and infestations Post procedural infection	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Injury, poisoning and procedural complications Postoperative ileus	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.84% 1/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Nervous system disorders Presyncope	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Infections and infestations Septic shock	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.84% 1/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Gastrointestinal disorders Small intestinal perforation	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Infections and infestations Staphylococcal infection	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Testis cancer	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Renal and urinary disorders Urinary retention	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.84% 1/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Infections and infestations Urinary tract infection	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.83% 1/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Infections and infestations Uterine infection	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.82% 1/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.00% 0/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.

Other adverse events

Other adverse events
Measure	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F1-Placebo Group n=120 participants at risk Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 1 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F2-Placebo Group n=121 participants at risk Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 182 and one dose of placebo (phosphate buffered saline, PBS) at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and Placebo vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, A/turkey H5N1 vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group n=119 participants at risk Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 3 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 3 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group n=119 participants at risk Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) vaccine formulation 1 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 1 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group n=122 participants at risk Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 4 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 4 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group n=120 participants at risk Healthy subjects aged 18 years of age or older at the time of enrolment were primed with one dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) formulation 2 at Day 0, one dose of placebo (phosphate buffered saline, PBS) at Day 182 followed by one booster dose of A/turkey H5N1 vaccine formulation 2 at Day 549. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) and A/turkey H5N1 vaccines were administered intramuscularly in the deltoid region of the non-dominant arm while, Placebo vaccine was administered intramuscularly in the deltoid region of the dominant arm.	Naïve Placebo-A/Turkey H5N1-Formulation 3 Group n=120 participants at risk Healthy subjects aged 18 years of age or older at the time of vaccination received one dose of placebo (phosphate buffered saline, PBS) at Day 0 followed by two doses of A/turkey H5N1 vaccine formulation 3, one dose administered at Day 182 and the other at Day 549. Placebo vaccine and one dose of A/turkey H5N1 vaccine (Day 549) was administered intramuscularly in the deltoid region of the non-dominant arm while the other dose of A/turkey H5N1 vaccine (Day 182) was administered intramuscularly in the deltoid region of the dominant arm.
General disorders Pain	81.7% 98/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	82.6% 100/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	84.9% 101/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	78.2% 93/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	83.6% 102/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	75.0% 90/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	79.2% 95/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
General disorders Redness	6.7% 8/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	3.3% 4/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	10.1% 12/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	7.6% 9/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	11.5% 14/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	3.3% 4/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	6.7% 8/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
General disorders Swelling	5.0% 6/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	5.8% 7/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	12.6% 15/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	3.4% 4/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	13.1% 16/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	7.5% 9/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	9.2% 11/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
General disorders Fatigue	37.5% 45/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	41.3% 50/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	39.5% 47/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	37.0% 44/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	34.4% 42/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	32.5% 39/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	39.2% 47/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
General disorders Headache	36.7% 44/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	41.3% 50/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	39.5% 47/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	37.0% 44/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	36.1% 44/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	29.2% 35/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	39.2% 47/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
General disorders Joint pain	27.5% 33/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	30.6% 37/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	30.3% 36/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	37.0% 44/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	34.4% 42/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	32.5% 39/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	25.0% 30/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
General disorders Muscle aches	45.0% 54/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	43.0% 52/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	49.6% 59/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	41.2% 49/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	39.3% 48/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	35.0% 42/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	45.8% 55/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
General disorders Shivering	10.0% 12/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	14.9% 18/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	13.4% 16/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	6.7% 8/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	16.4% 20/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	8.3% 10/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	15.0% 18/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
General disorders Sweating	12.5% 15/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	16.5% 20/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	12.6% 15/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	9.2% 11/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	11.5% 14/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	8.3% 10/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	15.0% 18/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
General disorders Fever	1.7% 2/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	4.1% 5/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	5.0% 6/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	2.5% 3/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	6.6% 8/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	1.7% 2/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	1.7% 2/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Infections and infestations Nasopharyngitis	12.5% 15/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	7.4% 9/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	7.6% 9/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	11.8% 14/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	9.8% 12/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	9.2% 11/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	5.0% 6/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	7.5% 9/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	6.6% 8/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	7.6% 9/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	10.1% 12/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	0.82% 1/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	8.3% 10/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	9.2% 11/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Nervous system disorders Headache	6.7% 8/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	9.1% 11/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	3.4% 4/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	5.0% 6/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	4.9% 6/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	8.3% 10/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	4.2% 5/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Respiratory, thoracic and mediastinal disorders Cough	7.5% 9/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	5.8% 7/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	5.0% 6/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	4.2% 5/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	3.3% 4/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	4.2% 5/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	4.2% 5/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Gastrointestinal disorders Nausea	1.7% 2/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	1.7% 2/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	8.4% 10/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	5.0% 6/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	2.5% 3/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	4.2% 5/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	4.2% 5/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Gastrointestinal disorders Diarrhoea	3.3% 4/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	3.3% 4/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	3.4% 4/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	6.7% 8/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	3.3% 4/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	4.2% 5/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	5.8% 7/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.
Infections and infestations Upper respiratory tract infection	5.8% 7/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	4.1% 5/121 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	5.0% 6/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	2.5% 3/119 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	4.9% 6/122 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	2.5% 3/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.	4.2% 5/120 • Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

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.
Publication restrictions are in place

Restriction type: OTHER