Trial Outcomes & Findings for Safety and Immunogenicity of Different Formulations of Monovalent Influenza A/Astrakhan/3212/2020 Like (H5N8) Virus Vaccine With AS03 Adjuvant System in Medically Stable Adults (NCT NCT05975840)

NCT ID: NCT05975840

Last Updated: 2025-08-19

Results Overview

Antibody titers were presented as geometric mean titers (GMTs).

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

518 participants

Primary outcome timeframe

At Day 43

Results posted on

2025-08-19

Participant Flow

Participant milestones

Participant milestones
Measure	Age Group 18-64: FLU Q-PAN H5N8 375_B Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 375_A Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_B Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_A Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_B Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_A Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_B Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_A Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.
Overall Study STARTED	66	65	64	63	66	64	66	64
Overall Study COMPLETED	61	52	59	59	61	61	62	58
Overall Study NOT COMPLETED	5	13	5	4	5	3	4	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Age Group 18-64: FLU Q-PAN H5N8 375_B Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 375_A Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_B Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_A Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_B Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_A Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_B Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_A Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.
Overall Study Other	1	0	0	0	1	0	0	0
Overall Study Lost to Follow-up	3	6	3	1	4	1	2	4
Overall Study Migrated/moved from the study area	1	0	0	0	0	0	0	0
Overall Study Withdrawal by Subject	0	5	2	2	0	2	2	1
Overall Study Protocol Violation	0	1	0	0	0	0	0	0
Overall Study Adverse Event	0	0	0	1	0	0	0	0
Overall Study Death	0	1	0	0	0	0	0	1

Baseline Characteristics

Based on Food and Drug Administration (FDA) immunogenicity criteria for influenza vaccines, age continuous is presented based on the age categories of 18-64 and 65 and above years of age.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Age Group 18-64: FLU Q-PAN H5N8 375_B n=66 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 375_A n=65 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_B n=64 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_A n=63 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_B n=66 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_A n=64 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_B n=66 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_A n=64 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.	Total n=518 Participants Total of all reporting groups
Age, Continuous 18-64 Years of age	42.5 Years STANDARD_DEVIATION 13.5 • n=66 Participants • Based on Food and Drug Administration (FDA) immunogenicity criteria for influenza vaccines, age continuous is presented based on the age categories of 18-64 and 65 and above years of age.	42.3 Years STANDARD_DEVIATION 12.3 • n=65 Participants • Based on Food and Drug Administration (FDA) immunogenicity criteria for influenza vaccines, age continuous is presented based on the age categories of 18-64 and 65 and above years of age.	40.7 Years STANDARD_DEVIATION 12.8 • n=64 Participants • Based on Food and Drug Administration (FDA) immunogenicity criteria for influenza vaccines, age continuous is presented based on the age categories of 18-64 and 65 and above years of age.	44.0 Years STANDARD_DEVIATION 13.4 • n=63 Participants • Based on Food and Drug Administration (FDA) immunogenicity criteria for influenza vaccines, age continuous is presented based on the age categories of 18-64 and 65 and above years of age.	—	—	—	—	42.4 Years STANDARD_DEVIATION 13.0 • n=258 Participants • Based on Food and Drug Administration (FDA) immunogenicity criteria for influenza vaccines, age continuous is presented based on the age categories of 18-64 and 65 and above years of age.
Age, Continuous >=65 Years of age	—	—	—	—	70.9 Years STANDARD_DEVIATION 4.7 • n=66 Participants • Based on Food and Drug Administration (FDA) immunogenicity criteria for influenza vaccines, age continuous is presented based on the age categories of 18-64 and 65 and above years of age.	71.9 Years STANDARD_DEVIATION 5.4 • n=64 Participants • Based on Food and Drug Administration (FDA) immunogenicity criteria for influenza vaccines, age continuous is presented based on the age categories of 18-64 and 65 and above years of age.	72.1 Years STANDARD_DEVIATION 5.2 • n=66 Participants • Based on Food and Drug Administration (FDA) immunogenicity criteria for influenza vaccines, age continuous is presented based on the age categories of 18-64 and 65 and above years of age.	71.0 Years STANDARD_DEVIATION 5.2 • n=64 Participants • Based on Food and Drug Administration (FDA) immunogenicity criteria for influenza vaccines, age continuous is presented based on the age categories of 18-64 and 65 and above years of age.	71.5 Years STANDARD_DEVIATION 5.1 • n=260 Participants • Based on Food and Drug Administration (FDA) immunogenicity criteria for influenza vaccines, age continuous is presented based on the age categories of 18-64 and 65 and above years of age.
Sex: Female, Male Female	34 Participants n=66 Participants	24 Participants n=65 Participants	29 Participants n=64 Participants	40 Participants n=63 Participants	35 Participants n=66 Participants	32 Participants n=64 Participants	41 Participants n=66 Participants	36 Participants n=64 Participants	271 Participants n=518 Participants
Sex: Female, Male Male	32 Participants n=66 Participants	41 Participants n=65 Participants	35 Participants n=64 Participants	23 Participants n=63 Participants	31 Participants n=66 Participants	32 Participants n=64 Participants	25 Participants n=66 Participants	28 Participants n=64 Participants	247 Participants n=518 Participants
Race/Ethnicity, Customized White	34 Participants n=66 Participants	41 Participants n=65 Participants	39 Participants n=64 Participants	38 Participants n=63 Participants	54 Participants n=66 Participants	50 Participants n=64 Participants	52 Participants n=66 Participants	47 Participants n=64 Participants	355 Participants n=518 Participants
Race/Ethnicity, Customized Other, combined to maintain patient confidentiality	32 Participants n=66 Participants	24 Participants n=65 Participants	25 Participants n=64 Participants	25 Participants n=63 Participants	12 Participants n=66 Participants	14 Participants n=64 Participants	14 Participants n=66 Participants	17 Participants n=64 Participants	163 Participants n=518 Participants

PRIMARY outcome

Timeframe: At Day 43

Population: Analysis was performed on the Per-protocol set (PPS) which included all eligible participants who received the 2 doses of study intervention as per protocol, had Day 1 and Day 43 post dose anti-HI immunogenicity results as per blood draw interval at Day 43. Only those participants with data available at the specified timepoint have been analyzed.

Antibody titers were presented as geometric mean titers (GMTs).

Outcome measures

Outcome measures
Measure	Age Group 18-64: FLU Q-PAN H5N8 375_B n=56 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 375_A n=46 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_B n=47 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_A n=49 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_B n=47 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_A n=40 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_B n=43 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_A n=44 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.
Hemagglutination-inhibiting (HI) Antibody Titers Against Vaccine-homologous H5N8	117.5 Titer Interval 97.0 to 141.8	175.2 Titer Interval 142.2 to 216.0	121.8 Titer Interval 99.2 to 150.1	176.6 Titer Interval 144.2 to 216.2	80.6 Titer Interval 64.3 to 101.1	110.2 Titer Interval 85.3 to 139.7	84.0 Titer Interval 66.6 to 107.0	129.3 Titer Interval 102.7 to 164.1

PRIMARY outcome

Timeframe: At Day 43

Population: PPS population. Only those participants with data available at the specified timepoint have been analyzed.

The GMFR is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.

Outcome measures

Outcome measures
Measure	Age Group 18-64: FLU Q-PAN H5N8 375_B n=56 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 375_A n=46 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_B n=47 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_A n=49 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_B n=47 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_A n=40 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_B n=43 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_A n=44 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.
Geometric Mean Fold Rise (GMFR) of Serum HI Antibody Titers Against Vaccine-homologous H5N8	21.7 Ratio Interval 18.3 to 26.7	33.0 Ratio Interval 26.8 to 40.7	23.7 Ratio Interval 18.7 to 28.3	33.1 Ratio Interval 27.2 to 40.7	11.7 Ratio Interval 9.3 to 14.6	14.3 Ratio Interval 12.3 to 20.2	12.8 Ratio Interval 9.6 to 15.4	19.5 Ratio Interval 14.8 to 23.7

PRIMARY outcome

Timeframe: At Day 43

Population: PPS population. Only those participants with data available at the specified timepoint have been analyzed.

Seroprotection rate is defined as the number of participants with HI titer value greater than or equal to (\>=) 1:40 which is considered as indicating protection.

Outcome measures

Outcome measures
Measure	Age Group 18-64: FLU Q-PAN H5N8 375_B n=56 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 375_A n=46 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_B n=47 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_A n=49 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_B n=47 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_A n=40 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_B n=43 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_A n=44 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.
Number of Seroprotected (SP) Participants for HI Antibody Titers	56 Participants	45 Participants	46 Participants	49 Participants	43 Participants	37 Participants	41 Participants	41 Participants

PRIMARY outcome

Timeframe: 7 days (Day 1 to Day 7) following dose 1

Population: The analysis was performed on the Diary Set for dose 1 (DS1) which included participants who received a study intervention and provided information on at least 1 solicited adverse event (AE) on at least 1 day.

Solicited administration site events included pain, redness and swelling.

Outcome measures

Outcome measures
Measure	Age Group 18-64: FLU Q-PAN H5N8 375_B n=65 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 375_A n=59 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_B n=62 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_A n=63 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_B n=64 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_A n=63 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_B n=64 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_A n=64 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.
Number of Participants Reporting Each Solicited Administration Site Event Following Dose 1 Pain	39 Participants	34 Participants	27 Participants	38 Participants	23 Participants	22 Participants	14 Participants	29 Participants
Number of Participants Reporting Each Solicited Administration Site Event Following Dose 1 Redness	3 Participants	0 Participants	2 Participants	2 Participants	0 Participants	1 Participants	0 Participants	4 Participants
Number of Participants Reporting Each Solicited Administration Site Event Following Dose 1 Swelling	2 Participants	0 Participants	2 Participants	2 Participants	2 Participants	1 Participants	0 Participants	5 Participants

PRIMARY outcome

Timeframe: 7 days (Day 22 to Day 28) following dose 2

Population: Analysis was performed on the DS2 which included participants who received a study intervention and provided information on at least 1 solicited AE on at least 1 day.

Solicited administration site events included pain, redness and swelling.

Outcome measures

Outcome measures
Measure	Age Group 18-64: FLU Q-PAN H5N8 375_B n=63 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 375_A n=52 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_B n=53 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_A n=55 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_B n=49 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_A n=45 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_B n=49 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_A n=49 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.
Number of Participants Reporting Each Solicited Administration Site Event Following Dose 2 Pain	31 Participants	19 Participants	21 Participants	24 Participants	17 Participants	14 Participants	12 Participants	15 Participants
Number of Participants Reporting Each Solicited Administration Site Event Following Dose 2 Redness	1 Participants	0 Participants	2 Participants	2 Participants	0 Participants	1 Participants	0 Participants	3 Participants
Number of Participants Reporting Each Solicited Administration Site Event Following Dose 2 Swelling	3 Participants	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants	2 Participants

PRIMARY outcome

Timeframe: 7 days (Day 1 to Day 7) following dose 1

Population: DS1 population

Solicited systemic events included fatigue, fever, headache, muscle ache, joint pain, shivering (chills), sweating, gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal pain). Fever is defined as temperature \>=38 degrees Celsius (°C) for oral route (preferred location for measuring temperature).

Outcome measures

Outcome measures
Measure	Age Group 18-64: FLU Q-PAN H5N8 375_B n=65 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 375_A n=59 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_B n=62 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_A n=63 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_B n=64 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_A n=63 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_B n=64 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_A n=64 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.
Number of Participants Reporting Each Solicited Systemic Event Following Dose 1 Shivering (chills)	6 Participants	7 Participants	1 Participants	5 Participants	5 Participants	2 Participants	0 Participants	4 Participants
Number of Participants Reporting Each Solicited Systemic Event Following Dose 1 Sweating	10 Participants	7 Participants	3 Participants	7 Participants	6 Participants	2 Participants	2 Participants	4 Participants
Number of Participants Reporting Each Solicited Systemic Event Following Dose 1 Nausea	11 Participants	6 Participants	4 Participants	7 Participants	5 Participants	2 Participants	5 Participants	4 Participants
Number of Participants Reporting Each Solicited Systemic Event Following Dose 1 Vomiting	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants Reporting Each Solicited Systemic Event Following Dose 1 Diarrhea	7 Participants	4 Participants	6 Participants	5 Participants	2 Participants	1 Participants	4 Participants	3 Participants
Number of Participants Reporting Each Solicited Systemic Event Following Dose 1 Fatigue	25 Participants	18 Participants	15 Participants	20 Participants	9 Participants	13 Participants	6 Participants	12 Participants
Number of Participants Reporting Each Solicited Systemic Event Following Dose 1 Fever	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants Reporting Each Solicited Systemic Event Following Dose 1 Headache	19 Participants	12 Participants	10 Participants	15 Participants	9 Participants	12 Participants	5 Participants	12 Participants
Number of Participants Reporting Each Solicited Systemic Event Following Dose 1 Muscle ache	23 Participants	22 Participants	15 Participants	26 Participants	9 Participants	12 Participants	8 Participants	16 Participants
Number of Participants Reporting Each Solicited Systemic Event Following Dose 1 Joint pain	12 Participants	9 Participants	3 Participants	9 Participants	2 Participants	9 Participants	4 Participants	6 Participants
Number of Participants Reporting Each Solicited Systemic Event Following Dose 1 Abdominal pain	6 Participants	3 Participants	2 Participants	4 Participants	7 Participants	3 Participants	5 Participants	4 Participants

PRIMARY outcome

Timeframe: 7 days (Day 22 to Day 28) following dose 2

Population: DS2 population

Outcome measures

Outcome measures
Measure	Age Group 18-64: FLU Q-PAN H5N8 375_B n=63 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 375_A n=52 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_B n=53 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_A n=55 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_B n=49 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_A n=45 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_B n=49 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_A n=49 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.
Number of Participants Reporting Each Solicited Systemic Event Following Dose 2 Fatigue	18 Participants	9 Participants	10 Participants	11 Participants	5 Participants	12 Participants	4 Participants	8 Participants
Number of Participants Reporting Each Solicited Systemic Event Following Dose 2 Fever	0 Participants	2 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants Reporting Each Solicited Systemic Event Following Dose 2 Headache	19 Participants	6 Participants	4 Participants	10 Participants	5 Participants	4 Participants	4 Participants	5 Participants
Number of Participants Reporting Each Solicited Systemic Event Following Dose 2 Muscle ache	17 Participants	10 Participants	10 Participants	15 Participants	6 Participants	7 Participants	3 Participants	7 Participants
Number of Participants Reporting Each Solicited Systemic Event Following Dose 2 Joint pain	8 Participants	6 Participants	3 Participants	6 Participants	3 Participants	1 Participants	2 Participants	4 Participants
Number of Participants Reporting Each Solicited Systemic Event Following Dose 2 Shivering (chills)	3 Participants	2 Participants	3 Participants	3 Participants	1 Participants	1 Participants	1 Participants	1 Participants
Number of Participants Reporting Each Solicited Systemic Event Following Dose 2 Sweating	5 Participants	3 Participants	3 Participants	5 Participants	4 Participants	2 Participants	0 Participants	1 Participants
Number of Participants Reporting Each Solicited Systemic Event Following Dose 2 Nausea	2 Participants	2 Participants	0 Participants	6 Participants	1 Participants	3 Participants	1 Participants	2 Participants
Number of Participants Reporting Each Solicited Systemic Event Following Dose 2 Vomiting	1 Participants	0 Participants	0 Participants	3 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants Reporting Each Solicited Systemic Event Following Dose 2 Diarrhea	6 Participants	3 Participants	3 Participants	3 Participants	1 Participants	1 Participants	2 Participants	1 Participants
Number of Participants Reporting Each Solicited Systemic Event Following Dose 2 Abdominal pain	2 Participants	2 Participants	2 Participants	6 Participants	1 Participants	1 Participants	1 Participants	1 Participants

PRIMARY outcome

Timeframe: 7 days (Day 1 to Day 7) following dose 1

Population: Analysis was performed on the Exposed set for dose 1 (ES1), which included participants who received a study intervention and for whom blood samples were collected and analyzed for the safety laboratory tests, at the specified timepoint.

Hemoglobin, white blood cells (WBC) increase, WBC decrease, platelets, neutrophils, lymphocytes and eosinophils were graded by FDA toxicity grading scale in which grades are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = potentially life threatening. Blood samples were collected for safety laboratory tests from the first 50% of participants of each age and dose group, at 7 days following each vaccination (i.e., Visit 2 and Visit 4).

Outcome measures

Outcome measures
Measure	Age Group 18-64: FLU Q-PAN H5N8 375_B n=33 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 375_A n=34 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_B n=33 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_A n=32 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_B n=32 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_A n=36 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_B n=35 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_A n=36 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.
Number of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1 Hemoglobin	2 Participants	5 Participants	1 Participants	6 Participants	7 Participants	6 Participants	7 Participants	7 Participants
Number of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1 WBC Increase	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants	1 Participants
Number of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1 WBC Decrease	2 Participants	2 Participants	0 Participants	3 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1 Platelets	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1 Neutrophils Absolute	3 Participants	1 Participants	2 Participants	3 Participants	0 Participants	2 Participants	1 Participants	1 Participants
Number of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1 Lymphocytes Absolute	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	5 Participants	1 Participants	0 Participants
Number of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 1 Eosinophils Absolute	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: 7 days (Day 22 to Day 28) following dose 2

Population: Analysis was performed on the Exposed set for dose 2 (ES2), which included participants who received a study intervention and for whom blood samples were collected and analyzed for the safety laboratory tests, at the specified timepoint.

Hemoglobin, WBC increase, WBC decrease, platelets, neutrophils, lymphocytes and eosinophils were graded by FDA toxicity grading scale in which grades are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = potentially life threatening. Blood samples were collected for safety laboratory tests from the first 50% of participants of each age and dose group, at 7 days following each vaccination (i.e., Visit 2 and Visit 4).

Outcome measures

Outcome measures
Measure	Age Group 18-64: FLU Q-PAN H5N8 375_B n=31 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 375_A n=24 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_B n=29 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_A n=28 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_B n=23 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_A n=23 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_B n=22 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_A n=23 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.
Number of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2 Hemoglobin	5 Participants	3 Participants	3 Participants	2 Participants	2 Participants	4 Participants	3 Participants	4 Participants
Number of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2 WBC Increase	2 Participants	2 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	2 Participants
Number of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2 WBC Decrease	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2 Platelets	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2 Neutrophils Absolute	2 Participants	0 Participants	3 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2 Lymphocytes Absolute	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	1 Participants
Number of Participants With Any Increase in Toxicity Grading in Hematological Laboratory Parameters Following Dose 2 Eosinophils Absolute	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: 7 days (Day 1 to Day 7) following dose 1

Sodium increase, sodium decrease, potassium increase, potassium decrease, creatinine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, total bilirubin and blood urea nitrogen (BUN) were graded by FDA toxicity grading scale in which grades are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = potentially life threatening. Blood samples were collected for safety laboratory tests from the first 50% of participants of each age and dose group, at 7 days following each vaccination (i.e., Visit 2 and Visit 4).

Outcome measures

Outcome measures
Measure	Age Group 18-64: FLU Q-PAN H5N8 375_B n=33 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 375_A n=34 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_B n=33 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_A n=33 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_B n=34 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_A n=36 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_B n=35 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_A n=36 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.
Number of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1 Sodium Increase	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants	0 Participants
Number of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1 Sodium Decrease	2 Participants	3 Participants	3 Participants	1 Participants	4 Participants	4 Participants	5 Participants	4 Participants
Number of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1 Potassium Increase	1 Participants	1 Participants	6 Participants	1 Participants	5 Participants	7 Participants	2 Participants	5 Participants
Number of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1 Potassium Decrease	1 Participants	1 Participants	4 Participants	1 Participants	0 Participants	0 Participants	1 Participants	4 Participants
Number of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1 Creatinine	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1 ALT	0 Participants	1 Participants	1 Participants	1 Participants	2 Participants	1 Participants	0 Participants	2 Participants
Number of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1 AST	0 Participants	1 Participants	2 Participants	0 Participants	0 Participants	0 Participants	3 Participants	4 Participants
Number of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1 Alkaline Phosphatase	1 Participants	3 Participants	2 Participants	0 Participants	4 Participants	3 Participants	2 Participants	3 Participants
Number of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1 Total Bilirubin	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 1 BUN	0 Participants	1 Participants	0 Participants	0 Participants	2 Participants	5 Participants	4 Participants	2 Participants

PRIMARY outcome

Timeframe: 7 days (Day 22 to Day 28) following dose 2

Sodium increase, sodium decrease, potassium increase, potassium decrease, creatinine, ALT, AST, alkaline phosphatase, total bilirubin and BUN were graded by FDA toxicity grading scale in which grades are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = potentially life threatening. Blood samples were collected for safety laboratory tests from the first 50% of participants of each age and dose group, at 7 days following each vaccination (i.e., Visit 2 and Visit 4).

Outcome measures

Outcome measures
Measure	Age Group 18-64: FLU Q-PAN H5N8 375_B n=32 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 375_A n=26 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_B n=29 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_A n=28 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_B n=24 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_A n=23 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_B n=22 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_A n=23 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.
Number of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2 Sodium Increase	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2 Sodium Decrease	1 Participants	2 Participants	1 Participants	2 Participants	1 Participants	2 Participants	2 Participants	1 Participants
Number of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2 Potassium Increase	2 Participants	1 Participants	1 Participants	1 Participants	4 Participants	1 Participants	4 Participants	3 Participants
Number of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2 Potassium Decrease	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants
Number of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2 Creatinine	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2 ALT	1 Participants	3 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2 AST	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	4 Participants	0 Participants
Number of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2 Alkaline Phosphatase	1 Participants	3 Participants	0 Participants	0 Participants	3 Participants	2 Participants	2 Participants	3 Participants
Number of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2 Total Bilirubin	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Any Increase in Toxicity Grading in Biochemical Laboratory Parameters Following Dose 2 BUN	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants	3 Participants	1 Participants	5 Participants

PRIMARY outcome

Timeframe: 21 days (Day 1 to Day 22) following dose 1

Population: Analysis was performed on the total ES population that reported unsolicited AEs for dose 1 at specified timepoints.

An unsolicited adverse event is defined as an adverse event that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.

Outcome measures

Outcome measures
Measure	Age Group 18-64: FLU Q-PAN H5N8 375_B n=66 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 375_A n=65 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_B n=64 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_A n=63 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_B n=66 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_A n=64 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_B n=66 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_A n=64 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.
Number of Participants Reporting Unsolicited AEs Following Dose 1	4 Participants	6 Participants	7 Participants	7 Participants	4 Participants	5 Participants	5 Participants	8 Participants

PRIMARY outcome

Timeframe: 21 days (Day 22 to Day 43) following dose 2

Population: Analysis was performed on the total ES population that reported unsolicited AEs for dose 2 at specified timepoints.

Outcome measures

Outcome measures
Measure	Age Group 18-64: FLU Q-PAN H5N8 375_B n=63 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 375_A n=52 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_B n=54 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_A n=55 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_B n=49 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_A n=45 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_B n=49 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_A n=49 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.
Number of Participants Reporting Unsolicited AEs Following Dose 2	3 Participants	4 Participants	2 Participants	3 Participants	6 Participants	3 Participants	3 Participants	1 Participants

PRIMARY outcome

Timeframe: 21 days (Day 1 to Day 22) following dose 1

Population: Analysis was performed on the total ES population that reported unsolicited MAEs for dose 1 at specified timepoints.

MAE is defined as an AE that results in an unscheduled visit to a medical professional (e.g., symptoms or illnesses requiring a hospitalization, emergency room visit, or visit to/by a healthcare provider).

Outcome measures

Outcome measures
Measure	Age Group 18-64: FLU Q-PAN H5N8 375_B n=66 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 375_A n=65 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_B n=64 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_A n=63 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_B n=66 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_A n=64 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_B n=66 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_A n=64 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.
Number of Participants Reporting Unsolicited Medically Attended Adverse Events (MAEs) Following Dose 1	1 Participants	3 Participants	3 Participants	3 Participants	2 Participants	1 Participants	1 Participants	3 Participants

PRIMARY outcome

Timeframe: 21 days (Day 22 to Day 43) following dose 2

Population: Analysis was performed on the total ES population that reported unsolicited MAEs for dose 2 at specified timepoints.

Outcome measures

Outcome measures
Measure	Age Group 18-64: FLU Q-PAN H5N8 375_B n=63 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 375_A n=52 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_B n=54 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_A n=55 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_B n=49 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_A n=45 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_B n=49 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_A n=49 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.
Number of Participants Reporting Unsolicited MAEs Following Dose 2	2 Participants	1 Participants	1 Participants	2 Participants	1 Participants	0 Participants	2 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 6 months post dose 2 (administered on Day 22)

Population: Analysis was performed on the total ES population that reported unsolicited MAEs for dose 2 at specified timepoints.

Outcome measures

Outcome measures
Measure	Age Group 18-64: FLU Q-PAN H5N8 375_B n=66 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 375_A n=65 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_B n=64 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_A n=63 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_B n=66 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_A n=64 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_B n=66 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_A n=64 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.
Number of Participants Reporting Unsolicited MAEs up to 6 Months Post Dose 2 (Administered on Day 22)	4 Participants	6 Participants	6 Participants	8 Participants	6 Participants	6 Participants	11 Participants	8 Participants

PRIMARY outcome

Timeframe: From Day 1 to Day 43

Population: The analysis was performed on the Total ES which included participants who received a study intervention.

An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an abnormal pregnancy outcome (e.g., spontaneous abortion, fetal death, stillbirth, congenital anomalies, ectopic pregnancy), or is a suspected transmission of any infectious agent via an authorized medicinal product.

Outcome measures

Outcome measures
Measure	Age Group 18-64: FLU Q-PAN H5N8 375_B n=66 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 375_A n=65 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_B n=64 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_A n=63 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_B n=66 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_A n=64 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_B n=66 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_A n=64 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.
Number of Participants Reporting Serious Adverse Events (SAEs) up to Day 43	1 Participants	1 Participants	0 Participants	2 Participants	0 Participants	0 Participants	1 Participants	1 Participants

PRIMARY outcome

Timeframe: Day 1 to 6 months post dose 2 (administered on Day 22)

Population: The analysis was performed on the Total ES which included participants who received a study intervention.

Outcome measures

Outcome measures
Measure	Age Group 18-64: FLU Q-PAN H5N8 375_B n=66 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 375_A n=65 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_B n=64 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_A n=63 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_B n=66 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_A n=64 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_B n=66 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_A n=64 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.
Number of Participants Reporting SAEs up to 6 Months Post Dose 2 (Administered on Day 22)	1 Participants	1 Participants	0 Participants	2 Participants	2 Participants	2 Participants	2 Participants	2 Participants

PRIMARY outcome

Timeframe: From Day 1 to Day 43

Population: The analysis was performed on the Total ES which included participants who received a study intervention.

pIMDs are defined a subset of AEs of special interest that includes autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.

Outcome measures

Outcome measures
Measure	Age Group 18-64: FLU Q-PAN H5N8 375_B n=66 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 375_A n=65 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_B n=64 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_A n=63 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_B n=66 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_A n=64 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_B n=66 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_A n=64 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.
Number of Participants Reporting Potential Immune-mediated Diseases (pIMDs) up to Day 43	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 1 to 6 months post dose 2 (administered on Day 22)

Population: The analysis was performed on the Total ES which included participants who received a study intervention.

Outcome measures

Outcome measures
Measure	Age Group 18-64: FLU Q-PAN H5N8 375_B n=66 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 375_A n=65 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_B n=64 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_A n=63 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_B n=66 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_A n=64 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_B n=66 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_A n=64 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.
Number of Participants Reporting pIMDs up to 6 Months Post Dose 2 (Administered on Day 22)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1, Day 22, and 6 months post dose 2 (administered on Day 22)

Population: PPS population. Only those participants with data available at the specified time points have been analyzed.

Antibody titers were presented as geometric mean titers (GMTs).

Outcome measures

Outcome measures
Measure	Age Group 18-64: FLU Q-PAN H5N8 375_B n=64 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 375_A n=62 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_B n=59 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_A n=56 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_B n=62 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_A n=56 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_B n=60 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_A n=60 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.
HI Antibody Titers Against Vaccine-homologous H5N8 Day 1	5.4 Titer Interval 5.0 to 5.8	5.2 Titer Interval 5.0 to 5.5	5.2 Titer Interval 5.0 to 5.4	5.4 Titer Interval 4.9 to 5.9	6.7 Titer Interval 5.9 to 7.6	7.7 Titer Interval 6.6 to 9.1	6.4 Titer Interval 5.9 to 7.1	6.6 Titer Interval 5.9 to 7.4
HI Antibody Titers Against Vaccine-homologous H5N8 Day 22	49.1 Titer Interval 40.5 to 59.0	54.2 Titer Interval 43.8 to 66.8	52.7 Titer Interval 43.2 to 65.3	56.5 Titer Interval 46.2 to 69.0	40.2 Titer Interval 31.4 to 51.5	39.7 Titer Interval 28.8 to 49.5	44.7 Titer Interval 35.4 to 59.1	54.5 Titer Interval 43.3 to 71.5
HI Antibody Titers Against Vaccine-homologous H5N8 6 months post dose 2	23.7 Titer Interval 19.8 to 27.9	26.4 Titer Interval 21.9 to 31.8	26.5 Titer Interval 22.2 to 32.4	30.8 Titer Interval 25.7 to 36.8	25.5 Titer Interval 20.7 to 31.0	28.5 Titer Interval 22.3 to 35.0	25.3 Titer Interval 20.9 to 31.4	29.0 Titer Interval 23.7 to 36.2

SECONDARY outcome

Timeframe: At Day 22, and 6 months post dose 2 (administered on Day 22)

Population: PPS population. Only those participants with data available at the specified time point have been analyzed.

The GMFR is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.

Outcome measures

Outcome measures
Measure	Age Group 18-64: FLU Q-PAN H5N8 375_B n=59 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 375_A n=47 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_B n=49 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_A n=52 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_B n=47 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_A n=40 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_B n=44 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_A n=46 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.
GMFR of Serum HI Antibody Titers Against Vaccine-homologous H5N8 Day 22	9.1 Ratio Interval 7.6 to 11.1	10.2 Ratio Interval 8.3 to 12.6	10.2 Ratio Interval 8.2 to 12.3	10.6 Ratio Interval 8.7 to 13.0	5.8 Ratio Interval 4.5 to 7.5	5.1 Ratio Interval 4.2 to 7.2	6.9 Ratio Interval 5.1 to 8.6	8.3 Ratio Interval 6.3 to 10.4
GMFR of Serum HI Antibody Titers Against Vaccine-homologous H5N8 6 months post dose 2	4.3 Ratio Interval 3.7 to 5.2	5.0 Ratio Interval 4.1 to 6.0	5.1 Ratio Interval 4.2 to 6.1	5.8 Ratio Interval 4.8 to 6.9	3.6 Ratio Interval 3.0 to 4.5	3.9 Ratio Interval 3.2 to 5.0	3.8 Ratio Interval 3.0 to 4.5	4.3 Ratio Interval 3.4 to 5.2

SECONDARY outcome

Timeframe: At Day 1, Day 22, and 6 months post dose 2 (administered on Day 22)

Population: PPS population. Only those participants with data available at the specified timepoint have been analyzed.

Seroprotection rate is defined as the number of participants with HI titer value \>= 1:40 which is considered as indicating protection.

Outcome measures

Outcome measures
Measure	Age Group 18-64: FLU Q-PAN H5N8 375_B n=64 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 375_A n=62 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_B n=59 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_A n=56 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_B n=62 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_A n=56 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_B n=60 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_A n=60 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.
Number of Seroprotected Participants for HI Antibody Titers Day 1	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Seroprotected Participants for HI Antibody Titers Day 22	40 Participants	40 Participants	39 Participants	43 Participants	25 Participants	24 Participants	29 Participants	33 Participants
Number of Seroprotected Participants for HI Antibody Titers 6 months post dose 2	14 Participants	20 Participants	17 Participants	25 Participants	14 Participants	17 Participants	13 Participants	20 Participants

SECONDARY outcome

Timeframe: At Day 22, Day 43 and 6 months post dose 2 (administered on Day 22)

Population: PPS population. Only those participants with data available at the specified timepoint have been analyzed.

HI seroconversion is defined as a post-vaccination titer \>=1:40 in the serum of participants with pre-vaccination titer below 1:10 or as a \>=4-fold rise in post-vaccination HI titer with pre-vaccination titer \>=1:10.

Outcome measures

Outcome measures
Measure	Age Group 18-64: FLU Q-PAN H5N8 375_B n=59 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 375_A n=47 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_B n=49 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_A n=52 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_B n=47 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_A n=40 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_B n=44 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_A n=46 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.
Number of Seroconverted Participants for HI Antibody Titers Day 22	40 Participants	39 Participants	39 Participants	42 Participants	21 Participants	21 Participants	29 Participants	31 Participants
Number of Seroconverted Participants for HI Antibody Titers Day 43	55 Participants	45 Participants	46 Participants	49 Participants	39 Participants	36 Participants	40 Participants	40 Participants
Number of Seroconverted Participants for HI Antibody Titers 6 months post dose 2	13 Participants	20 Participants	17 Participants	24 Participants	12 Participants	14 Participants	12 Participants	20 Participants

SECONDARY outcome

Timeframe: At Day 1, Day 22, and 6 months post dose 2 (administered on Day 22)

Population: PPS population subset for MN testing. Only those participants with data available at the specified time points have been analyzed.

Microneutralization testing was performed on 50% of the participants, randomly selected and equally distributed across the different age groups.

Outcome measures

Outcome measures
Measure	Age Group 18-64: FLU Q-PAN H5N8 375_B n=32 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 375_A n=31 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_B n=31 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_A n=26 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_B n=32 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_A n=29 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_B n=29 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_A n=29 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.
Microneutralization (MN) Antibody Titers for a Subset of Participants Day 1	5.0 Titer 95% CI not calculated as there was no variation in the micro neutralizing titer at visit 1 and it was below level of detection (i.e., below lower limit of quantification) for all participants in this group.	5.0 Titer 95% CI not calculated as there was no variation in the micro neutralizing titer at visit 1 and it was below level of detection (i.e., below lower limit of quantification) for all participants in this group.	5.0 Titer 95% CI not calculated as there was no variation in the micro neutralizing titer at visit 1 and it was below level of detection (i.e., below lower limit of quantification) for all participants in this group.	5.1 Titer Interval 4.9 to 5.4	5.0 Titer 95% CI not calculated as there was no variation in the micro neutralizing titer at visit 1 and it was below level of detection (i.e., below lower limit of quantification) for all participants in this group.	5.2 Titer Interval 4.8 to 5.6	5.1 Titer Interval 4.9 to 5.4	5.0 Titer 95% CI not calculated as there was no variation in the micro neutralizing titer at visit 1 and it was below level of detection (i.e., below lower limit of quantification) for all participants in this group.
Microneutralization (MN) Antibody Titers for a Subset of Participants Day 22	7.0 Titer Interval 5.6 to 8.6	7.8 Titer Interval 6.0 to 10.0	8.1 Titer Interval 6.4 to 10.1	8.7 Titer Interval 7.0 to 11.3	6.4 Titer Interval 5.3 to 7.7	5.8 Titer Interval 4.6 to 7.2	6.7 Titer Interval 5.5 to 8.3	7.0 Titer Interval 5.7 to 8.5
Microneutralization (MN) Antibody Titers for a Subset of Participants 6 months post dose 2	6.4 Titer Interval 5.3 to 7.6	6.9 Titer Interval 5.6 to 8.5	7.0 Titer Interval 5.8 to 8.4	6.9 Titer Interval 5.7 to 8.4	6.5 Titer Interval 5.3 to 8.0	6.2 Titer Interval 4.7 to 8.1	6.1 Titer Interval 4.9 to 7.5	9.1 Titer Interval 7.2 to 11.4

SECONDARY outcome

Timeframe: At Day 1, Day 22, and 6 months post dose 2 (administered on Day 22)

Population: PPS population subset for MN testing. Only those participants with data available at the specified time points have been analyzed.

A seropositive participant is a participant whose antibody titer is greater than or equal to the assay cut-off value of 1:40.

Outcome measures

Outcome measures
Measure	Age Group 18-64: FLU Q-PAN H5N8 375_B n=32 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 375_A n=31 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_B n=31 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_A n=26 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_B n=32 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_A n=29 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_B n=29 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_A n=29 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.
Number of Seropositive Participants for MN Antibody Titers for a Subset of Participants Day 1	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Seropositive Participants for MN Antibody Titers for a Subset of Participants Day 22	10 Participants	10 Participants	13 Participants	14 Participants	5 Participants	3 Participants	8 Participants	8 Participants
Number of Seropositive Participants for MN Antibody Titers for a Subset of Participants 6 months post dose 2	8 Participants	8 Participants	8 Participants	8 Participants	8 Participants	4 Participants	4 Participants	10 Participants

SECONDARY outcome

Timeframe: At Day 22, Day 43, and 6 months post dose 2 (administered on Day 22)

Population: PPS population subset for MN testing. Only those participants with data available at the specified time points have been analyzed.

MN VR is defined as titer \>=4x LLOQ for participants with pre-vaccination titer below LLOQ or a \>=4 -fold increase from pre-vaccination titer for participants with pre-vaccination titer \>=LLOQ.

Outcome measures

Outcome measures
Measure	Age Group 18-64: FLU Q-PAN H5N8 375_B n=30 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 375_A n=22 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_B n=28 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group 18-64: FLU Q-PAN H5N8 750_A n=25 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_B n=24 Participants Participants received 2 doses of 375\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 375_A n=17 Participants Participants received 2 doses of 375\_A vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_B n=21 Participants Participants received 2 doses of 750\_B vaccine formulation, 21 days apart.	Age Group >=65: FLU Q-PAN H5N8 750_A n=23 Participants Participants received 2 doses of 750\_A vaccine formulation, 21 days apart.
Number of Participants Meeting Vaccine Response (VR) Criteria of MN Antibody Titers for a Subset of Participants Day 22	0 Participants	2 Participants	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Number of Participants Meeting Vaccine Response (VR) Criteria of MN Antibody Titers for a Subset of Participants Day 43	10 Participants	12 Participants	10 Participants	13 Participants	2 Participants	6 Participants	2 Participants	9 Participants
Number of Participants Meeting Vaccine Response (VR) Criteria of MN Antibody Titers for a Subset of Participants 6 months post dose 2	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants

Adverse Events

Age Group 18-64: FLU Q-PAN H5N8 375_B

Serious events: 1 serious events

Other events: 50 other events

Deaths: 0 deaths

Age Group 18-64: FLU Q-PAN H5N8 375_A

Serious events: 1 serious events

Other events: 40 other events

Deaths: 1 deaths

Age Group 18-64: FLU Q-PAN H5N8 750_B

Serious events: 0 serious events

Other events: 40 other events

Deaths: 0 deaths