Trial Outcomes & Findings for Safety, Tolerability and Immunogenicity of Two Doses of Adjuvanted Monovalent Influenza Vaccine Administered to Healthy Adult and Elderly Subjects (NCT NCT00841763)

NCT ID: NCT00841763

Last Updated: 2021-04-23

Results Overview

To assess the safety and tolerability profile of two doses of the MF59-adjuvanted A/Vietnam/1194/2004 pandemic influenza vaccine (aH5N1), each containing 7.5 μg of H5N1 antigen in terms of the number of participants who reported local and systemic reactions up to 6 days after each vaccination per vaccination group.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 3647 participants
• Primary outcome timeframe: Up to 6 days after each vaccination.
• Results posted on: 2021-04-23

Participant Flow

Subjects were enrolled from 27 centers across Finland and Germany.

All subjects enrolled were included in the trial.

Participant milestones

Measure	TIV + aH5N1 (18-60 Yrs) First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).	PL+ aTIV (18-60 Yrs) First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).	TIV + aH5N1 (>60 Yrs) First dose of non adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 influenza vaccine (aH5N1).	PL+ aTIV (>60 Yrs) First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).
Overall Study STARTED	2691	681	219	56
Overall Study COMPLETED	2529	624	211	53
Overall Study NOT COMPLETED	162	57	8	3

Reasons for withdrawal

Measure	TIV + aH5N1 (18-60 Yrs) First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).	PL+ aTIV (18-60 Yrs) First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).	TIV + aH5N1 (>60 Yrs) First dose of non adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 influenza vaccine (aH5N1).	PL+ aTIV (>60 Yrs) First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).
Overall Study Withdrawal by Subject	60	17	4	1
Overall Study Adverse Event	9	10	3	2
Overall Study Lost to Follow-up	63	25	0	0
Overall Study Protocol Violation	20	3	1	0
Overall Study Administrative Reasons	3	1	0	0
Overall Study Unable to Classify	7	1	0	0

Baseline Characteristics

Subjects analyzed is not consistent with Participant module due to randomization errors.

Baseline characteristics by cohort

Measure	TIV + aH5N1 n=2911 Participants First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).	PL+ aTIV n=735 Participants First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).	Total n=3646 Participants Total of all reporting groups
Age, Customized <= 60 years	40.7 Years STANDARD_DEVIATION 11.6 • n=2692 Participants • Subjects analyzed is not consistent with Participant module due to randomization errors.	40.5 Years STANDARD_DEVIATION 12.0 • n=679 Participants • Subjects analyzed is not consistent with Participant module due to randomization errors.	40.7 Years STANDARD_DEVIATION 11.7 • n=3371 Participants • Subjects analyzed is not consistent with Participant module due to randomization errors.
Age, Customized >60 years	61.9 Years STANDARD_DEVIATION 1.4 • n=219 Participants • Subjects analyzed is not consistent with Participant module due to randomization errors.	62.1 Years STANDARD_DEVIATION 1.8 • n=56 Participants • Subjects analyzed is not consistent with Participant module due to randomization errors.	61.9 Years STANDARD_DEVIATION 1.5 • n=275 Participants • Subjects analyzed is not consistent with Participant module due to randomization errors.
Sex/Gender, Customized Female (<=60 yrs)	1502 participants n=2911 Participants • The enrolled set as randomized is reported in the Participant Flow Module but in the Baseline Measure module, the enrolled set as treated is reported (2 randomization errors, 2 subjects were changed from TIV + aH5N1 group to PL+ aTIV group). Moreover, a subset to the enrolled population as treated excluded the one subject who was not vaccinated.	388 participants n=735 Participants • The enrolled set as randomized is reported in the Participant Flow Module but in the Baseline Measure module, the enrolled set as treated is reported (2 randomization errors, 2 subjects were changed from TIV + aH5N1 group to PL+ aTIV group). Moreover, a subset to the enrolled population as treated excluded the one subject who was not vaccinated.	1890 participants n=3646 Participants • The enrolled set as randomized is reported in the Participant Flow Module but in the Baseline Measure module, the enrolled set as treated is reported (2 randomization errors, 2 subjects were changed from TIV + aH5N1 group to PL+ aTIV group). Moreover, a subset to the enrolled population as treated excluded the one subject who was not vaccinated.
Sex/Gender, Customized Male (<=60 yrs)	1190 participants n=2911 Participants • The enrolled set as randomized is reported in the Participant Flow Module but in the Baseline Measure module, the enrolled set as treated is reported (2 randomization errors, 2 subjects were changed from TIV + aH5N1 group to PL+ aTIV group). Moreover, a subset to the enrolled population as treated excluded the one subject who was not vaccinated.	291 participants n=735 Participants • The enrolled set as randomized is reported in the Participant Flow Module but in the Baseline Measure module, the enrolled set as treated is reported (2 randomization errors, 2 subjects were changed from TIV + aH5N1 group to PL+ aTIV group). Moreover, a subset to the enrolled population as treated excluded the one subject who was not vaccinated.	1481 participants n=3646 Participants • The enrolled set as randomized is reported in the Participant Flow Module but in the Baseline Measure module, the enrolled set as treated is reported (2 randomization errors, 2 subjects were changed from TIV + aH5N1 group to PL+ aTIV group). Moreover, a subset to the enrolled population as treated excluded the one subject who was not vaccinated.
Sex/Gender, Customized Female (>60 yrs)	109 participants n=2911 Participants • The enrolled set as randomized is reported in the Participant Flow Module but in the Baseline Measure module, the enrolled set as treated is reported (2 randomization errors, 2 subjects were changed from TIV + aH5N1 group to PL+ aTIV group). Moreover, a subset to the enrolled population as treated excluded the one subject who was not vaccinated.	28 participants n=735 Participants • The enrolled set as randomized is reported in the Participant Flow Module but in the Baseline Measure module, the enrolled set as treated is reported (2 randomization errors, 2 subjects were changed from TIV + aH5N1 group to PL+ aTIV group). Moreover, a subset to the enrolled population as treated excluded the one subject who was not vaccinated.	137 participants n=3646 Participants • The enrolled set as randomized is reported in the Participant Flow Module but in the Baseline Measure module, the enrolled set as treated is reported (2 randomization errors, 2 subjects were changed from TIV + aH5N1 group to PL+ aTIV group). Moreover, a subset to the enrolled population as treated excluded the one subject who was not vaccinated.
Sex/Gender, Customized Male (>60 yrs)	110 participants n=2911 Participants • The enrolled set as randomized is reported in the Participant Flow Module but in the Baseline Measure module, the enrolled set as treated is reported (2 randomization errors, 2 subjects were changed from TIV + aH5N1 group to PL+ aTIV group). Moreover, a subset to the enrolled population as treated excluded the one subject who was not vaccinated.	28 participants n=735 Participants • The enrolled set as randomized is reported in the Participant Flow Module but in the Baseline Measure module, the enrolled set as treated is reported (2 randomization errors, 2 subjects were changed from TIV + aH5N1 group to PL+ aTIV group). Moreover, a subset to the enrolled population as treated excluded the one subject who was not vaccinated.	138 participants n=3646 Participants • The enrolled set as randomized is reported in the Participant Flow Module but in the Baseline Measure module, the enrolled set as treated is reported (2 randomization errors, 2 subjects were changed from TIV + aH5N1 group to PL+ aTIV group). Moreover, a subset to the enrolled population as treated excluded the one subject who was not vaccinated.

PRIMARY outcome

Timeframe: Up to 6 days after each vaccination.

Population: The analysis was performed on the Safety Set population.

To assess the safety and tolerability profile of two doses of the MF59-adjuvanted A/Vietnam/1194/2004 pandemic influenza vaccine (aH5N1), each containing 7.5 μg of H5N1 antigen in terms of the number of participants who reported local and systemic reactions up to 6 days after each vaccination per vaccination group.

Outcome measures

Measure	TIV + aH5N1 (18-60 Yrs) n=2611 Participants First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).	PL+ aTIV (18-60 Yrs) n=658 Participants First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).	TIV + aH5N1 (>60 Yrs) First dose of non adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 influenza vaccine (aH5N1).	PL+ aTIV (>60 Yrs) First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).	TIV + aH5N1 (18-60 Yrs) SRH Assay First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).	TIV + aH5N1 (>60 Yrs) SRH Assay First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).
Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine. Local reactions	1755 Participants	502 Participants	—	—	—	—
Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine. Injection site ecchymosis	237 Participants	78 Participants	—	—	—	—
Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine. Injection site erythema	652 Participants	206 Participants	—	—	—	—
Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine. Injection site induration	549 Participants	181 Participants	—	—	—	—
Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine. Injection site swelling	409 Participants	162 Participants	—	—	—	—
Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine. Injection site pain	1537 Participants	448 Participants	—	—	—	—
Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine. Systemic reactions	1387 Participants	386 Participants	—	—	—	—
Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine. Chills	342 Participants	118 Participants	—	—	—	—
Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine. Malaise	347 Participants	130 Participants	—	—	—	—
Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine. Myalgia	869 Participants	277 Participants	—	—	—	—
Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine. Arthralgia	188 Participants	79 Participants	—	—	—	—
Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine. Nausea	193 Participants	64 Participants	—	—	—	—
Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine. Headache	668 Participants	189 Participants	—	—	—	—
Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine. Sweating	237 Participants	658 Participants	—	—	—	—
Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine. Fatigue	638 Participants	188 Participants	—	—	—	—
Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine. Fever ≥ 38°C	28 Participants	12 Participants	—	—	—	—
Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine. Stayed at home	64 Participants	22 Participants	—	—	—	—
Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic Influenza Vaccine. Analgesic Antipyretic medi. used	361 Participants	114 Participants	—	—	—	—

PRIMARY outcome

Timeframe: Upto Day 224 post vaccination

Population: The analysis was performed on the Safety set population.

To report safety data from a large enough number of subjects exposed to adjuvanted pandemic influenza vaccine aH5N1 capable of detecting rare adverse events (AEs), i.e. events occurring at a frequency of <=0.1%, & uncommon AEs in elderly, i.e. occurring at a frequency of <=1% of subjects.

Outcome measures

Measure	TIV + aH5N1 (18-60 Yrs) n=2693 Participants First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).	PL+ aTIV (18-60 Yrs) n=679 Participants First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).	TIV + aH5N1 (>60 Yrs) n=219 Participants First dose of non adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 influenza vaccine (aH5N1).	PL+ aTIV (>60 Yrs) n=56 Participants First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).	TIV + aH5N1 (18-60 Yrs) SRH Assay First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).	TIV + aH5N1 (>60 Yrs) SRH Assay First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).
Number of Subjects Exposed to Adjuvanted Pandemic Influenza Vaccine.	2692 Participants	679 Participants	219 Participants	56 Participants	—	—

SECONDARY outcome

Timeframe: Up to 6 days after each vaccination.

Population: The analysis was performed on the Safety set population.

To evaluate the safety and tolerability profile of two doses of the adjuvanted pandemic H5N1 vaccine (aH5N1) as compared with the MF59-adjuvanted seasonal trivalent influenza vaccine (aTIV), in terms of the number of subjects who reported local and systemic reactions up to 6 days after each vaccination per vaccination group.

Outcome measures

Measure	TIV + aH5N1 (18-60 Yrs) n=2611 Participants First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).	PL+ aTIV (18-60 Yrs) n=658 Participants First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).	TIV + aH5N1 (>60 Yrs) n=214 Participants First dose of non adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 influenza vaccine (aH5N1).	PL+ aTIV (>60 Yrs) n=54 Participants First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).	TIV + aH5N1 (18-60 Yrs) SRH Assay First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).	TIV + aH5N1 (>60 Yrs) SRH Assay First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).
The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV. Local reactions	1755 Subjects	502 Subjects	115 Subjects	30 Subjects	—	—
The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV. Injection site ecchymosis (N= 2610,658,214,54)	237 Subjects	78 Subjects	23 Subjects	7 Subjects	—	—
The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV. Injection site erythema	652 Subjects	206 Subjects	45 Subjects	14 Subjects	—	—
The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV. Injection site induration (N= 2610,658,214,54)	549 Subjects	181 Subjects	22 Subjects	10 Subjects	—	—
The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV. Injection site swelling	409 Subjects	162 Subjects	22 Subjects	6 Subjects	—	—
The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV. Injection site pain (N= 2610,658,214,54)	1537 Subjects	448 Subjects	87 Subjects	21 Subjects	—	—
The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV. Systemic reactions	1387 Subjects	386 Subjects	95 Subjects	26 Subjects	—	—
The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV. Chills	342 Subjects	118 Subjects	29 Subjects	10 Subjects	—	—
The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV. Malaise (N= 2610,658,214,54)	347 Subjects	130 Subjects	25 Subjects	6 Subjects	—	—
The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV. Myalgia	869 Subjects	277 Subjects	59 Subjects	16 Subjects	—	—
The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV. Arthralgia (N= 2610,658,214,54)	188 Subjects	79 Subjects	15 Subjects	5 Subjects	—	—
The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV. Nausea	193 Subjects	64 Subjects	14 Subjects	3 Subjects	—	—
The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV. Headache (N= 2610,658,214,54)	668 Subjects	189 Subjects	38 Subjects	10 Subjects	—	—
The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV. Sweating	237 Subjects	63 Subjects	10 Subjects	2 Subjects	—	—
The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV. Fatigue (N= 2610,658,214,54)	638 Subjects	188 Subjects	27 Subjects	7 Subjects	—	—
The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV. Fever ≥38°C	28 Subjects	12 Subjects	1 Subjects	1 Subjects	—	—
The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV. Stayed at home	64 Subjects	22 Subjects	3 Subjects	1 Subjects	—	—
The Number of Subjects With at Least One Reactogenicity Sign After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine as Compared With the Adjuvanted Seasonal Trivalent Influenza Vaccine aTIV. Analg. Antipyr. Medi. used	361 Subjects	114 Subjects	27 Subjects	6 Subjects	—	—

SECONDARY outcome

Timeframe: Day 22, Day 43, Day 64

Population: The analysis was performed on the Full Analysis Set (FAS) of the Immunogenicity Subset - All subjects in the enrolled population who were in the immunogenicity subset and who actually received at least one dose of AdjPanH5N1 or Adj Seasonal, and provided at leatr one evaluable serum sample both before and after baseline.

To evaluate the immunogenicity of two doses of the adjuvanted pandemic H5N1 vaccine (aH5N1), each containing 7.5µg of H5N1 antigen, in terms of GMTs against the homologous A/Vietnam/1194/2004 strain, as determined by Hemagglutination Inhibition (HI) assay and Microneutralization (MN) assay.

Outcome measures

Measure	TIV + aH5N1 (18-60 Yrs) n=196 Participants First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).	PL+ aTIV (18-60 Yrs) n=205 Participants First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).	TIV + aH5N1 (>60 Yrs) n=197 Participants First dose of non adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 influenza vaccine (aH5N1).	PL+ aTIV (>60 Yrs) n=209 Participants First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).	TIV + aH5N1 (18-60 Yrs) SRH Assay First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).	TIV + aH5N1 (>60 Yrs) SRH Assay First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).
Geometric Mean Titers (GMTs) After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain. Day 22 (baseline)	6.17 Titers Interval 5.58 to 6.83	6.98 Titers Interval 6.21 to 7.85	11 Titers Interval 10.0 to 11.0	10 Titers Interval 9.97 to 11.0	—	—
Geometric Mean Titers (GMTs) After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain. Day 43	14 Titers Interval 11.0 to 17.0	15 Titers Interval 12.0 to 18.0	17 Titers Interval 15.0 to 19.0	17 Titers Interval 15.0 to 19.0	—	—
Geometric Mean Titers (GMTs) After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain. Day 64	44 Titers Interval 34.0 to 56.0	36 Titers Interval 28.0 to 45.0	65 Titers Interval 56.0 to 77.0	45 Titers Interval 39.0 to 53.0	—	—

SECONDARY outcome

Timeframe: Day 22, Day 43, Day 64

Population: The analysis was performed on FAS population.

To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine aH5N1, in terms of GMAs as determined by Single Radial Hemolysis (SRH) assay.

GMA: For each vaccine group, least squares GMAs (for SRH data), associated 2-sided 95% confidence interval and median, minimal, and maximal titer values were determined for study Day 22, Day 43 and Day 64.

Outcome measures

Measure	TIV + aH5N1 (18-60 Yrs) n=197 Participants First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).	PL+ aTIV (18-60 Yrs) n=210 Participants First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).	TIV + aH5N1 (>60 Yrs) First dose of non adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 influenza vaccine (aH5N1).	PL+ aTIV (>60 Yrs) First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).	TIV + aH5N1 (18-60 Yrs) SRH Assay First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).	TIV + aH5N1 (>60 Yrs) SRH Assay First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).
Geometric Mean Areas (GMAs) After Two Doses of the Adjuvanted Pandemic Vaccine (aH5N1). Day 22 (baseline)	11 Areas (mm^2) Interval 9.45 to 12.0	13 Areas (mm^2) Interval 11.0 to 14.0	—	—	—	—
Geometric Mean Areas (GMAs) After Two Doses of the Adjuvanted Pandemic Vaccine (aH5N1). Day 43	21 Areas (mm^2) Interval 18.0 to 24.0	20 Areas (mm^2) Interval 18.0 to 23.0	—	—	—	—
Geometric Mean Areas (GMAs) After Two Doses of the Adjuvanted Pandemic Vaccine (aH5N1). Day 64	43 Areas (mm^2) Interval 39.0 to 47.0	37 Areas (mm^2) Interval 33.0 to 41.0	—	—	—	—

SECONDARY outcome

Timeframe: Day 43/Day 22, Day 64/Day 22

Population: The analysis was performed on FAS population.

To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine (aH5N1), each containing 7.5µg of H5N1 antigen,in terms of GMRs against the homologous A/Vietnam/1194/2004 strain, as determined by HI, MN and SRH assays.

Outcome measures

Measure	TIV + aH5N1 (18-60 Yrs) n=196 Participants First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).	PL+ aTIV (18-60 Yrs) n=203 Participants First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).	TIV + aH5N1 (>60 Yrs) n=197 Participants First dose of non adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 influenza vaccine (aH5N1).	PL+ aTIV (>60 Yrs) n=208 Participants First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).	TIV + aH5N1 (18-60 Yrs) SRH Assay n=197 Participants First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).	TIV + aH5N1 (>60 Yrs) SRH Assay n=209 Participants First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).
Geometric Mean Ratios (GMRs) After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain. Day 43 to Day 22 (N= 196,201,197,207,197,208)	2.25 Ratios Interval 1.86 to 2.72	2.14 Ratios Interval 1.8 to 2.54	1.58 Ratios Interval 1.39 to 1.79	1.63 Ratios Interval 1.43 to 1.84	1.95 Ratios Interval 1.72 to 2.2	1.57 Ratios Interval 1.41 to 1.75
Geometric Mean Ratios (GMRs) After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain. Day 64 to Day 22	7.1 Ratios Interval 5.52 to 9.14	5.15 Ratios Interval 4.15 to 6.4	6.21 Ratios Interval 5.29 to 7.29	4.42 Ratios Interval 3.79 to 5.15	4.03 Ratios Interval 3.54 to 4.59	2.9 Ratios Interval 2.53 to 3.31

SECONDARY outcome

Timeframe: Day 22, Day 43 and Day 64

Population: The analysis was performed on FAS population.

To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine aH5N1, each containing 7.5µg of H5N1 antigen, against the homologous A/Vietnam/1194/2004 strain, in terms of percentages of subjects achieving HI titers ≥ 40 and GMAs ≥ 25mm^2, as determined by HI and SRH assays.

GMA: For each vaccine group, least squares GMAs (for SRH data), associated 2-sided 95% confidence interval and median, minimal, and maximal titer values were determined for study Day 22, Day 43 and Day 64.

Outcome measures

Measure	TIV + aH5N1 (18-60 Yrs) n=196 Participants First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).	PL+ aTIV (18-60 Yrs) n=205 Participants First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).	TIV + aH5N1 (>60 Yrs) n=197 Participants First dose of non adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 influenza vaccine (aH5N1).	PL+ aTIV (>60 Yrs) n=210 Participants First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).	TIV + aH5N1 (18-60 Yrs) SRH Assay First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).	TIV + aH5N1 (>60 Yrs) SRH Assay First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).
Percentages of Subjects With HI Titers ≥ 40 and GMAs ≥ 25mm^2, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain. Day 22 (baseline)	6 Percentages of subjects Interval 3.0 to 10.0	8 Percentages of subjects Interval 5.0 to 12.0	19 Percentages of subjects Interval 14.0 to 26.0	25 Percentages of subjects Interval 20.0 to 32.0	—	—
Percentages of Subjects With HI Titers ≥ 40 and GMAs ≥ 25mm^2, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain. Day 43	30 Percentages of subjects Interval 23.0 to 37.0	31 Percentages of subjects Interval 25.0 to 38.0	48 Percentages of subjects Interval 41.0 to 55.0	46 Percentages of subjects Interval 39.0 to 53.0	—	—
Percentages of Subjects With HI Titers ≥ 40 and GMAs ≥ 25mm^2, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain. Day 64	61 Percentages of subjects Interval 53.0 to 67.0	57 Percentages of subjects Interval 50.0 to 64.0	91 Percentages of subjects Interval 87.0 to 95.0	82 Percentages of subjects Interval 76.0 to 87.0	—	—

SECONDARY outcome

Timeframe: Day 43/Day 22 and Day 64/Day 22

Population: The analysis was performed on FAS population.

To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine aH5N1, each containing 7.5µg of H5N1 antigen, against the homologous A/Vietnam/1194/2004 strain, in terms of percentages of subjects achieving seroconversion or significant increase in antibody titer as measured by HI and SRH assays.

Outcome measures

Measure	TIV + aH5N1 (18-60 Yrs) n=196 Participants First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).	PL+ aTIV (18-60 Yrs) n=203 Participants First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).	TIV + aH5N1 (>60 Yrs) n=197 Participants First dose of non adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 influenza vaccine (aH5N1).	PL+ aTIV (>60 Yrs) n=209 Participants First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).	TIV + aH5N1 (18-60 Yrs) SRH Assay First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).	TIV + aH5N1 (>60 Yrs) SRH Assay First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).
Percentages of Subjects Achieving Seroconversion or Significant Increase in Antibody Titer After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain. Day 43/Day 22	23 Percentages of subjects Interval 18.0 to 30.0	22 Percentages of subjects Interval 16.0 to 28.0	37 Percentages of subjects Interval 30.0 to 44.0	23 Percentages of subjects Interval 17.0 to 29.0	—	—
Percentages of Subjects Achieving Seroconversion or Significant Increase in Antibody Titer After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain. Day 64/Day 22	56 Percentages of subjects Interval 49.0 to 63.0	50 Percentages of subjects Interval 43.0 to 57.0	78 Percentages of subjects Interval 72.0 to 84.0	63 Percentages of subjects Interval 56.0 to 69.0	—	—

SECONDARY outcome

Timeframe: Day 22, Day 43 and Day 64

Population: The analysis was performed on FAS population.

To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine (aH5N1), each containing 7.5µg of H5N1 antigen, in terms of GMTs against the heterologous A/turkey/Turkey/1/2005 strain, as determined by HI and MN assays.

Outcome measures

Measure	TIV + aH5N1 (18-60 Yrs) n=197 Participants First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).	PL+ aTIV (18-60 Yrs) n=208 Participants First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).	TIV + aH5N1 (>60 Yrs) n=197 Participants First dose of non adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 influenza vaccine (aH5N1).	PL+ aTIV (>60 Yrs) n=210 Participants First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).	TIV + aH5N1 (18-60 Yrs) SRH Assay First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).	TIV + aH5N1 (>60 Yrs) SRH Assay First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).
GMTs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain. Day 22 (baseline)	6.03 Titers Interval 5.55 to 6.55	6.85 Titers Interval 6.21 to 7.55	11 Titers Interval 10.0 to 11.0	11 Titers Interval 11.0 to 12.0	—	—
GMTs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain. Day 43	8.03 Titers Interval 7.07 to 9.12	8.87 Titers Interval 7.69 to 10.0	15 Titers Interval 13.0 to 17.0	15 Titers Interval 13.0 to 16.0	—	—
GMTs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain. Day 64	12 Titers Interval 9.77 to 14.0	12 Titers Interval 10.0 to 14.0	30 Titers Interval 26.0 to 35.0	23 Titers Interval 20.0 to 26.0	—	—

SECONDARY outcome

Timeframe: Day 22, Day 43 and Day 64

Population: The analysis was performed on FAS population.

To evaluate the immunogenicity of two doses of adjuvanted pandemic vaccine aH5N1, each containing 7.5µg of H5N1 antigen, in terms of GMAs against the heterologous A/turkey/Turkey/1/2005 strain, as determined by SRH assay.

GMA: For each vaccine group, least squares GMAs (for SRH data), associated 2-sided 95% confidence interval and median, minimal, and maximal titer values were determined for study Day 22, Day 43 and Day 64.

Outcome measures

Measure	TIV + aH5N1 (18-60 Yrs) n=197 Participants First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).	PL+ aTIV (18-60 Yrs) n=210 Participants First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).	TIV + aH5N1 (>60 Yrs) First dose of non adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 influenza vaccine (aH5N1).	PL+ aTIV (>60 Yrs) First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).	TIV + aH5N1 (18-60 Yrs) SRH Assay First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).	TIV + aH5N1 (>60 Yrs) SRH Assay First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).
GMAs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain. Day 22 (baseline)	9.89 Areas (mm^2) Interval 8.82 to 11.0	12 Areas (mm^2) Interval 10.0 to 13.0	—	—	—	—
GMAs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain. Day 43	14 Areas (mm^2) Interval 13.0 to 16.0	14 Areas (mm^2) Interval 13.0 to 16.0	—	—	—	—
GMAs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain. Day 64	23 Areas (mm^2) Interval 21.0 to 26.0	20 Areas (mm^2) Interval 18.0 to 23.0	—	—	—	—

SECONDARY outcome

Timeframe: Day 43/Day 22 and Day 64/Day 22

Population: The analysis was performed on FAS population.

To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine aH5N1, each containing 7.5µg of H5N1 antigen, in terms of GMRs against the heterologous A/turkey/Turkey/1/2005 strain, as determined by HI, MN and SRH assays.

Outcome measures

Measure	TIV + aH5N1 (18-60 Yrs) n=197 Participants First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).	PL+ aTIV (18-60 Yrs) n=207 Participants First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).	TIV + aH5N1 (>60 Yrs) n=197 Participants First dose of non adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 influenza vaccine (aH5N1).	PL+ aTIV (>60 Yrs) n=208 Participants First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).	TIV + aH5N1 (18-60 Yrs) SRH Assay n=197 Participants First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).	TIV + aH5N1 (>60 Yrs) SRH Assay n=209 Participants First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).
GMRs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain. Day 43/Day 22	1.33 Ratios Interval 1.19 to 1.49	1.29 Ratios Interval 1.16 to 1.45	1.39 Ratios Interval 1.25 to 1.54	1.29 Ratios Interval 1.17 to 1.42	1.44 Ratios Interval 1.31 to 1.59	1.25 Ratios Interval 1.15 to 1.36
GMRs After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain. Day 64/Day 22	1.92 Ratios Interval 1.64 to 2.25	1.79 Ratios Interval 1.56 to 2.06	2.77 Ratios Interval 2.4 to 3.2	2.01 Ratios Interval 1.78 to 2.26	2.37 Ratios Interval 2.1 to 2.67	1.74 Ratios Interval 1.57 to 1.94

SECONDARY outcome

Timeframe: Day 22, Day 43 and Day 64

Population: The analysis was performed on FAS population.

To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine aH5N1, each containing 7.5µg of H5N1 antigen, against the heterologous A/turkey/Turkey/1/2005 strain, in terms of percentages of subjects achieving HI titers ≥ 40 and GMAs ≥ 25mm^2 as determined by HI and SRH assays.

GMA: For each vaccine group, least squares GMAs (for SRH data), associated 2-sided 95% confidence interval and median, minimal, and maximal titer values were determined for study Vaccine on Day 22, Day 43, Day 64.

Outcome measures

Measure	TIV + aH5N1 (18-60 Yrs) n=197 Participants First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).	PL+ aTIV (18-60 Yrs) n=208 Participants First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).	TIV + aH5N1 (>60 Yrs) n=197 Participants First dose of non adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 influenza vaccine (aH5N1).	PL+ aTIV (>60 Yrs) n=210 Participants First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).	TIV + aH5N1 (18-60 Yrs) SRH Assay First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).	TIV + aH5N1 (>60 Yrs) SRH Assay First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).
Percentages of Subjects With HI ≥ 40 and GMAs ≥ 25mm^2, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain. Day 22 (baseline)	3 Percentages of subjects Interval 1.0 to 7.0	5 Percentages of subjects Interval 2.0 to 9.0	16 Percentages of subjects Interval 11.0 to 22.0	23 Percentages of subjects Interval 18.0 to 30.0	—	—
Percentages of Subjects With HI ≥ 40 and GMAs ≥ 25mm^2, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain. Day 43	11 Percentages of subjects Interval 7.0 to 16.0	15 Percentages of subjects Interval 10.0 to 20.0	30 Percentages of subjects Interval 24.0 to 37.0	32 Percentages of subjects Interval 26.0 to 39.0	—	—
Percentages of Subjects With HI ≥ 40 and GMAs ≥ 25mm^2, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain. Day 64	23 Percentages of subjects Interval 18.0 to 30.0	25 Percentages of subjects Interval 19.0 to 32.0	59 Percentages of subjects Interval 52.0 to 66.0	48 Percentages of subjects Interval 41.0 to 55.0	—	—

SECONDARY outcome

Timeframe: Day 43/Day 22 and Day 64/Day 22)

Population: The analysis was performed on FAS population.

To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine aH5N1, each containing 7.5µg of H5N1 antigen, against the heterologous A/turkey/Turkey/1/2005 strain, in terms of percentages of subjects achieving seroconversion or significant increase in antibody titer as measured by HI and SRH assays.

Outcome measures

Measure	TIV + aH5N1 (18-60 Yrs) n=197 Participants First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).	PL+ aTIV (18-60 Yrs) n=207 Participants First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).	TIV + aH5N1 (>60 Yrs) n=197 Participants First dose of non adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 influenza vaccine (aH5N1).	PL+ aTIV (>60 Yrs) n=209 Participants First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).	TIV + aH5N1 (18-60 Yrs) SRH Assay First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).	TIV + aH5N1 (>60 Yrs) SRH Assay First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).
Percentages of Subjects Achieving Seroconversion or Significant Increase in Antibody Titers, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain. Day 43/Day 22	9 Percentages of subjects Interval 5.0 to 13.0	8 Percentages of subjects Interval 5.0 to 12.0	18 Percentages of subjects Interval 13.0 to 24.0	10 Percentages of subjects Interval 6.0 to 14.0	—	—
Percentages of Subjects Achieving Seroconversion or Significant Increase in Antibody Titers, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain. Day 64/Day 22	19 Percentages of subjects Interval 14.0 to 25.0	19 Percentages of subjects Interval 14.0 to 25.0	49 Percentages of subjects Interval 42.0 to 56.0	32 Percentages of subjects Interval 26.0 to 39.0	—	—

SECONDARY outcome

Timeframe: Day 22, Day 43 and Day 64

Population: The analysis was performed on FAS population.

To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine (aH5N1), each containing 7.5μg of H5N1 antigen, against the homologous A/Vietnam/1194/2004 strain, in terms of percentages of subjects achieving MN Titers ≥20, ≥ 40, ≥80 on Days 22, Day 43 and Day 64.

Outcome measures

Measure	TIV + aH5N1 (18-60 Yrs) n=197 Participants First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).	PL+ aTIV (18-60 Yrs) n=209 Participants First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).	TIV + aH5N1 (>60 Yrs) First dose of non adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 influenza vaccine (aH5N1).	PL+ aTIV (>60 Yrs) First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).	TIV + aH5N1 (18-60 Yrs) SRH Assay First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).	TIV + aH5N1 (>60 Yrs) SRH Assay First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).
Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain. Day 22 (MN titer ≥ 20)	3 Percentages of subjects Interval 1.0 to 6.0	2 Percentages of subjects Interval 1.0 to 5.0	—	—	—	—
Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain. Day 43 (MN titer ≥ 20)	27 Percentages of subjects Interval 21.0 to 34.0	25 Percentages of subjects Interval 19.0 to 31.0	—	—	—	—
Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain. Day 64 (MN titer ≥ 20)	79 Percentages of subjects Interval 73.0 to 85.0	72 Percentages of subjects Interval 65.0 to 78.0	—	—	—	—
Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain. Day 22 (MN titer ≥ 40)	2 Percentages of subjects Interval 0.0 to 4.0	1 Percentages of subjects Interval 0.0 to 3.0	—	—	—	—
Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain. Day 43 (MN titer ≥ 40)	16 Percentages of subjects Interval 11.0 to 22.0	19 Percentages of subjects Interval 14.0 to 25.0	—	—	—	—
Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain. Day 64 (MN titer ≥ 40)	67 Percentages of subjects Interval 60.0 to 74.0	57 Percentages of subjects Interval 50.0 to 64.0	—	—	—	—
Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain. Day 22 (MN titer ≥ 80)	1 Percentages of subjects Interval 0.0 to 4.0	0 Percentages of subjects Interval 0.0 to 2.0	—	—	—	—
Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain. Day 43 (MN titer ≥ 80)	9 Percentages of subjects Interval 6.0 to 14.0	13 Percentages of subjects Interval 8.0 to 18.0	—	—	—	—
Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Homologous A/Vietnam/1194/2004 Strain. Day 64 (MN titer ≥ 80)	50 Percentages of subjects Interval 43.0 to 57.0	33 Percentages of subjects Interval 26.0 to 40.0	—	—	—	—

SECONDARY outcome

Timeframe: Day 22, Day 43 and Day 64

Population: The analysis was performed on FAS population.

To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine aH5N1, each containing 7.5μg of H5N1 antigen, against the heterologous A/turkey/Turkey/1/2005 Strain, in terms of percentages of subjects achieving MN Titers ≥20, ≥ 40, ≥80 on Day 22, Day 43 and Day 64.

Outcome measures

Measure	TIV + aH5N1 (18-60 Yrs) n=197 Participants First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).	PL+ aTIV (18-60 Yrs) n=210 Participants First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).	TIV + aH5N1 (>60 Yrs) First dose of non adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 influenza vaccine (aH5N1).	PL+ aTIV (>60 Yrs) First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).	TIV + aH5N1 (18-60 Yrs) SRH Assay First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).	TIV + aH5N1 (>60 Yrs) SRH Assay First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).
Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain. Day 22 (MN titer≥20)	5 Percentages of subjects Interval 2.0 to 8.0	9 Percentages of subjects Interval 6.0 to 14.0	—	—	—	—
Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain. Day 43 (MN titer ≥ 20)	23 Percentages of subjects Interval 17.0 to 29.0	21 Percentages of subjects Interval 15.0 to 27.0	—	—	—	—
Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain. Day 64 (MN titer ≥ 20; N= 197, 208)	59 Percentages of subjects Interval 52.0 to 66.0	47 Percentages of subjects Interval 40.0 to 54.0	—	—	—	—
Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain. Day 22 (MN titer ≥ 40)	3 Percentages of subjects Interval 1.0 to 7.0	3 Percentages of subjects Interval 1.0 to 7.0	—	—	—	—
Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain. Day 43 (MN titer ≥ 40)	13 Percentages of subjects Interval 8.0 to 18.0	14 Percentages of subjects Interval 9.0 to 19.0	—	—	—	—
Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain. Day 64 (MN titer ≥ 40)	39 Percentages of subjects Interval 32.0 to 46.0	30 Percentages of subjects Interval 24.0 to 37.0	—	—	—	—
Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain. Day 22 (MN titer ≥ 80)	2 Percentages of subjects Interval 1.0 to 5.0	0.012 Percentages of subjects Interval 0.012 to 3.0	—	—	—	—
Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain. Day 43 (MN titer ≥ 80)	8 Percentages of subjects Interval 4.0 to 12.0	6 Percentages of subjects Interval 3.0 to 10.0	—	—	—	—
Percentages of Subjects With MN Titers ≥20, ≥40, ≥80, After Two Doses of the Adjuvanted Pandemic aH5N1 Vaccine Against the Heterologous A/Turkey/Turkey/1/2005 Strain. Day 64 (MN titer ≥ 80)	19 Percentages of subjects Interval 14.0 to 26.0	12 Percentages of subjects Interval 8.0 to 17.0	—	—	—	—

SECONDARY outcome

Timeframe: Day 43/Day 22 and Day 64/Day 22

Population: The analysis was performed on FAS population.

To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine aH5N1, each containing 7.5μg of H5N1 antigen, against the homologous A/Vietnam/1194/2004 strain, in terms of percentages of subjects achieving at least a four-fold rise in MN antibody titer on Day 43 and Day 64, compared to Day 22.

Outcome measures

Measure	TIV + aH5N1 (18-60 Yrs) n=197 Participants First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).	PL+ aTIV (18-60 Yrs) n=208 Participants First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).	TIV + aH5N1 (>60 Yrs) First dose of non adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 influenza vaccine (aH5N1).	PL+ aTIV (>60 Yrs) First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).	TIV + aH5N1 (18-60 Yrs) SRH Assay First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).	TIV + aH5N1 (>60 Yrs) SRH Assay First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).
Percentages of Subjects Achieving at Least a Four-fold Rise in MN Antibody Titer on Day 43 and Day 64, Compared to Day 22 Against Homologous Strains. Day 43/Day 22	14 Percentages of subjects Interval 10.0 to 20.0	18 Percentages of subjects Interval 13.0 to 24.0	—	—	—	—
Percentages of Subjects Achieving at Least a Four-fold Rise in MN Antibody Titer on Day 43 and Day 64, Compared to Day 22 Against Homologous Strains. Day 64/Day 22	65 Percentages of subjects Interval 58.0 to 72.0	55 Percentages of subjects Interval 48.0 to 62.0	—	—	—	—

SECONDARY outcome

Timeframe: Day 43/Day 22 and Day 64/Day 22

Population: The analysis was performed on FAS population.

To evaluate the immunogenicity of two doses of the adjuvanted pandemic vaccine (aH5N1), each containing 7.5μg of H5N1 antigen, against Heterologous A/turkey/Turkey/1/2005 Strain, in terms of percentages of subjects achieving at least a four-fold rise in MN antibody titer on Day 43 and Day 64, compared to Day 22.

Outcome measures

Measure	TIV + aH5N1 (18-60 Yrs) n=197 Participants First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).	PL+ aTIV (18-60 Yrs) n=208 Participants First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).	TIV + aH5N1 (>60 Yrs) First dose of non adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 influenza vaccine (aH5N1).	PL+ aTIV (>60 Yrs) First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).	TIV + aH5N1 (18-60 Yrs) SRH Assay First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).	TIV + aH5N1 (>60 Yrs) SRH Assay First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).
Percentages of Subjects Achieving at Least a Four-fold Rise in MN Antibody Titer on Day 43 and Day 64, Compared to Day 22 Against Heterologous Strains. Day 43/Day 22	9 Percentages of subjects Interval 5.0 to 14.0	9 Percentages of subjects Interval 6.0 to 14.0	—	—	—	—
Percentages of Subjects Achieving at Least a Four-fold Rise in MN Antibody Titer on Day 43 and Day 64, Compared to Day 22 Against Heterologous Strains. Day 64/Day 22	36 Percentages of subjects Interval 29.0 to 43.0	25 Percentages of subjects Interval 19.0 to 31.0	—	—	—	—

SECONDARY outcome

Timeframe: Day 1 through Day 224 post vaccination

Population: Analysis was done on safety population.

The number of subjects reporting any unsolicited AEs any, Possibly/probably related AEs, serious adverse events (SAEs), AEs leading to withdrawal (WD), AEs leading to death from Day 1 through Day 224 post vaccination.

Outcome measures

Measure	TIV + aH5N1 (18-60 Yrs) n=2611 Participants First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).	PL+ aTIV (18-60 Yrs) n=658 Participants First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).	TIV + aH5N1 (>60 Yrs) n=214 Participants First dose of non adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 influenza vaccine (aH5N1).	PL+ aTIV (>60 Yrs) n=54 Participants First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).	TIV + aH5N1 (18-60 Yrs) SRH Assay First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).	TIV + aH5N1 (>60 Yrs) SRH Assay First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).
Number of Subjects Reporting Unsolicited AEs After Vaccination. Any AEs	1329 Subjects	335 Subjects	103 Subjects	29 Subjects	—	—
Number of Subjects Reporting Unsolicited AEs After Vaccination. SAEs	45 Subjects	10 Subjects	4 Subjects	3 Subjects	—	—
Number of Subjects Reporting Unsolicited AEs After Vaccination. At least possibly related AEs	357 Subjects	103 Subjects	25 Subjects	13 Subjects	—	—
Number of Subjects Reporting Unsolicited AEs After Vaccination. AEs Leading to Premature Withdrawal	4 Subjects	4 Subjects	2 Subjects	1 Subjects	—	—
Number of Subjects Reporting Unsolicited AEs After Vaccination. Deaths	0 Subjects	0 Subjects	1 Subjects	0 Subjects	—	—

Adverse Events

TIV + aH5N1 (18-60 Yrs)

Serious events: 40 serious events

Other events: 2301 other events

Deaths: 0 deaths

PL + aTIV (18-60 Yrs)

Serious events: 9 serious events

Other events: 590 other events

Deaths: 0 deaths

TIV + aH5N1 (>60 Yrs)

Serious events: 1 serious events

Other events: 176 other events

Deaths: 0 deaths

PL + aTIV (>60 Yrs)

Serious events: 2 serious events

Other events: 45 other events

Deaths: 0 deaths

Serious adverse events

Measure	TIV + aH5N1 (18-60 Yrs) n=2680 participants at risk First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).	PL + aTIV (18-60 Yrs) n=676 participants at risk First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).	TIV + aH5N1 (>60 Yrs) n=222 participants at risk First dose of non adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 influenza vaccine (aH5N1).	PL + aTIV (>60 Yrs) n=56 participants at risk First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).
Reproductive system and breast disorders Ovarian cyst	0.04% 1/2680 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/676 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Ear and labyrinth disorders Sudden hearing loss	0.04% 1/2680 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/676 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Ear and labyrinth disorders Vertigo	0.04% 1/2680 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/676 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Endocrine disorders Goitre	0.04% 1/2680 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/676 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Gastrointestinal disorders Abdominal pain lower	0.04% 1/2680 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/676 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Gastrointestinal disorders Ileus	0.04% 1/2680 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/676 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Gastrointestinal disorders Inguinal hernia	0.04% 1/2680 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/676 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Gastrointestinal disorders Intestinal obstruction	0.04% 1/2680 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/676 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Gastrointestinal disorders Pancreatitis acute	0.04% 1/2680 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/676 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Infections and infestations Peritonitis	0.04% 1/2680 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/676 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Hepatobiliary disorders Cholecystitis acute	0.04% 1/2680 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/676 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Hepatobiliary disorders Cholelithiasis	0.04% 1/2680 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/676 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Immune system disorders Anaphylactic reaction	0.04% 1/2680 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/676 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Immune system disorders Anaphylactic shock	0.04% 1/2680 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/676 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Infections and infestations Appendicitis	0.19% 5/2680 • Number of events 5 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/676 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Infections and infestations Bacterial infection	0.00% 0/2680 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.15% 1/676 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Infections and infestations Endometritis	0.04% 1/2680 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/676 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Infections and infestations Gastroenteritis	0.07% 2/2680 • Number of events 2 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/676 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Infections and infestations Gastroenteritis clostridial	0.04% 1/2680 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/676 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Infections and infestations Herpes zoster opthalmic	0.04% 1/2680 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/676 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Infections and infestations Influenza	0.04% 1/2680 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/676 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Infections and infestations Pneumonia	0.04% 1/2680 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/676 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	1.8% 1/56 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Infections and infestations Pyelonephritis acute	0.04% 1/2680 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/676 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Infections and infestations Viral infection	0.04% 1/2680 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/676 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Injury, poisoning and procedural complications Clavicle fracture	0.04% 1/2680 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/676 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Injury, poisoning and procedural complications Concussion	0.07% 2/2680 • Number of events 2 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/676 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Injury, poisoning and procedural complications Foot fracture	0.04% 1/2680 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/676 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Injury, poisoning and procedural complications Gas poisoning	0.04% 1/2680 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/676 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/2680 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/676 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	1.8% 1/56 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Injury, poisoning and procedural complications Ligament sprain	0.04% 1/2680 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/676 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Injury, poisoning and procedural complications Ligament rupture	0.00% 0/2680 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.15% 1/676 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Injury, poisoning and procedural complications Skull fracture	0.04% 1/2680 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/676 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Injury, poisoning and procedural complications Thermal burn	0.04% 1/2680 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/676 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Injury, poisoning and procedural complications Vaccination failure	0.04% 1/2680 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/676 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Musculoskeletal and connective tissue disorders Back pain	0.04% 1/2680 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/676 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Musculoskeletal and connective tissue disorders Bone cyst	0.00% 0/2680 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.15% 1/676 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.04% 1/2680 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/676 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.04% 1/2680 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.15% 1/676 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cerebellar haemangioma	0.00% 0/2680 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.15% 1/676 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.04% 1/2680 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/676 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic neoplasm	0.04% 1/2680 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/676 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	0.04% 1/2680 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/676 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.07% 2/2680 • Number of events 2 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/676 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Respiratory, thoracic and mediastinal disorders Bronchial hyperactivity	0.00% 0/2680 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/676 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	1.8% 1/56 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Nervous system disorders Cerebral infraction	0.00% 0/2680 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.15% 1/676 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	1.8% 1/56 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Nervous system disorders Dystonia	0.00% 0/2680 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.15% 1/676 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Nervous system disorders Subarachnoid haemorrhage	0.04% 1/2680 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/676 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Pregnancy, puerperium and perinatal conditions Imminent abortion	0.04% 1/2680 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/676 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Psychiatric disorders Anxiety disorder	0.04% 1/2680 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/676 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Psychiatric disorders Schizophrenia,paranoid type	0.00% 0/2680 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.15% 1/676 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Renal and urinary disorders Urethral caruncle	0.00% 0/2680 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.15% 1/676 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.04% 1/2680 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/676 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/222 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Surgical and medical procedures Haemorrhoid operation	0.00% 0/2680 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/676 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.45% 1/222 • Number of events 1 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.

Other adverse events

Measure	TIV + aH5N1 (18-60 Yrs) n=2680 participants at risk First dose of non-adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 vaccine (aH5N1).	PL + aTIV (18-60 Yrs) n=676 participants at risk First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).	TIV + aH5N1 (>60 Yrs) n=222 participants at risk First dose of non adjuvanted seasonal trivalent influenza vaccine (TIV) followed by two doses of adjuvanted pandemic H5N1 influenza vaccine (aH5N1).	PL + aTIV (>60 Yrs) n=56 participants at risk First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (aTIV).
Gastrointestinal disorders Nausea	12.5% 334/2680 • Number of events 334 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	13.0% 88/676 • Number of events 88 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	8.6% 19/222 • Number of events 19 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	7.1% 4/56 • Number of events 4 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
General disorders Chills	19.9% 532/2680 • Number of events 532 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	22.5% 152/676 • Number of events 152 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	18.0% 40/222 • Number of events 40 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	23.2% 13/56 • Number of events 13 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
General disorders Fatigue	34.6% 927/2680 • Number of events 927 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	36.5% 247/676 • Number of events 247 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	17.1% 38/222 • Number of events 38 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	16.1% 9/56 • Number of events 9 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
General disorders Injection site erythema	38.8% 1041/2680 • Number of events 1041 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	36.7% 248/676 • Number of events 248 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	39.2% 87/222 • Number of events 87 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	32.1% 18/56 • Number of events 18 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
General disorders Injection site haemorrahage	13.7% 367/2680 • Number of events 367 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	16.4% 111/676 • Number of events 111 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	14.9% 33/222 • Number of events 33 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	23.2% 13/56 • Number of events 13 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
General disorders Injection site induration	31.0% 830/2680 • Number of events 830 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	28.8% 195/676 • Number of events 195 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	18.9% 42/222 • Number of events 42 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	23.2% 13/56 • Number of events 13 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
General disorders Injection site pain	64.9% 1738/2680 • Number of events 1738 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	67.9% 459/676 • Number of events 459 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	43.2% 96/222 • Number of events 96 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	37.5% 21/56 • Number of events 21 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
General disorders Injection site swelling	23.6% 632/2680 • Number of events 632 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	26.2% 177/676 • Number of events 177 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	12.6% 28/222 • Number of events 28 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	10.7% 6/56 • Number of events 6 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
General disorders Malaise	20.2% 542/2680 • Number of events 542 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	23.8% 161/676 • Number of events 161 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	14.9% 33/222 • Number of events 33 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	12.5% 7/56 • Number of events 7 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Infections and infestations Nasopharyngitis	8.1% 216/2680 • Number of events 216 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	8.7% 59/676 • Number of events 59 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	3.2% 7/222 • Number of events 7 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	0.00% 0/56 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Infections and infestations Upper respiratory tract infection	6.6% 176/2680 • Number of events 176 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	6.5% 44/676 • Number of events 44 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	3.6% 8/222 • Number of events 8 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	8.9% 5/56 • Number of events 5 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Infections and infestations Rhinitis	3.1% 83/2680 • Number of events 83 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	4.0% 27/676 • Number of events 27 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	1.8% 4/222 • Number of events 4 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	5.4% 3/56 • Number of events 3 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Musculoskeletal and connective tissue disorders Arthralgia	11.4% 306/2680 • Number of events 306 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	14.3% 97/676 • Number of events 97 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	8.6% 19/222 • Number of events 19 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	10.7% 6/56 • Number of events 6 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Musculoskeletal and connective tissue disorders Myalgia	40.6% 1088/2680 • Number of events 1088 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	43.8% 296/676 • Number of events 296 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	31.1% 69/222 • Number of events 69 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	30.4% 17/56 • Number of events 17 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Nervous system disorders Headache	38.5% 1031/2680 • Number of events 1031 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	37.4% 253/676 • Number of events 253 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	24.3% 54/222 • Number of events 54 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	32.1% 18/56 • Number of events 18 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.
Skin and subcutaneous tissue disorders Hyperhidrosis	13.3% 356/2680 • Number of events 356 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	12.4% 84/676 • Number of events 84 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	6.3% 14/222 • Number of events 14 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.	10.7% 6/56 • Number of events 6 • Throughout the study ie. Day 1 to Day 224 The number of subjects in the module for Adverse Events (AEs) differs from the number of subjects in the Participant Flow module. This is because the analysis for the AEs module is based on the safety population whereas the Participant Flow module refers to the enrolled population.

Additional Information

Posting Director

Novartis Vaccines and Diagnostics

Email: RegistryContactVaccinesUS@novartis.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60