Trial Outcomes & Findings for A Randomised, Double-blind, Placebo-controlled Phase IIb Trial to Test FLU-v Vaccine (NCT NCT02962908)

Last Updated: 2020-09-16

Results Overview

Comparison of the TH1 response in the treatment arms compared to placebo from baseline to day 42 following vaccination, calculated as the median fold change in the number of CD4+ and CD8+ T cells positive for IFN-gamma, TNF-alpha, IL-2 and CD107a. Fold change is calculated as the number of cells on day 42 divided by number of cells on day 0.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

175 participants

Primary outcome timeframe

day 0 to day 42

Results posted on

2020-09-16

Participant Flow

195 subjects were screened. Of those, N=20 subjects were removed from the study prior randomisation due to: * lost to follow up n=3 * didn't wish to continue after screening visit n=9 * did not meet inclusion/exclusion criteria n=8

Participant milestones

Participant milestones
Measure	2x Non-adjuvanted FLU-v FLU-v on Day 0 and Day 21 FLU-v: Subcutaneous injection in the upper arm with 500 ug of FLU-v as 0.5ml suspension in 0.01M HCl and 0.01M NaOH	1x Adjuvanted FLU-v adjuvanted FLU-v on Day 0, saline (0.5mL) on Day 21 adjuvanted FLU-v: Subcutaneous injection in the upper arm with 500ug of FLU-v emulsified in 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Non-adjuvanted Placebo saline solution (0.5ml) on Day 0 and Day 21 Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Adjuvanted Placebo Adjuvanted placebo on Day 0, saline (0.5mL) on Day 21 Saline: Subcutaneous injection in the upper arm with 0.5ml of saline Adjuvanted placebo: Subcutaneous injection in the upper arm with an emulsion made with 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection
Overall Study STARTED	58	58	32	27
Overall Study COMPLETED	58	50	32	24
Overall Study NOT COMPLETED	0	8	0	3

Reasons for withdrawal

Reasons for withdrawal
Measure	1x Adjuvanted FLU-v adjuvanted FLU-v on Day 0, saline (0.5mL) on Day 21 adjuvanted FLU-v: Subcutaneous injection in the upper arm with 500ug of FLU-v emulsified in 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Adjuvanted Placebo Adjuvanted placebo on Day 0, saline (0.5mL) on Day 21 Saline: Subcutaneous injection in the upper arm with 0.5ml of saline Adjuvanted placebo: Subcutaneous injection in the upper arm with an emulsion made with 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection
Overall Study Lost to Follow-up	3	1
Overall Study Withdrawal by Subject	3	2
Overall Study Protocol Violation	1	0
Overall Study Physician Decision	1	0

Baseline Characteristics

This baseline measure was only analysed in the FAS population, that is the Full Analysis Set which includes all those subjects that completed vaccination and had at least pre-vaccination immunogenicity data and at least one post-vaccination time point.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	2x Non-adjuvanted FLU-v n=58 Participants FLU-v on Day 0 and Day 21 FLU-v: Subcutaneous injection in the upper arm with 500 ug of FLU-v as 0.5ml suspension in 0.01M HCl and 0.01M NaOH	1x Adjuvanted FLU-v n=57 Participants adjuvanted FLU-v on Day 0, saline (0.5mL) on Day 21 adjuvanted FLU-v: Subcutaneous injection in the upper arm with 500ug of FLU-v emulsified in 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Non-adjuvanted Placebo n=32 Participants saline solution (0.5ml) on Day 0 and Day 21 Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Adjuvanted Placebo n=27 Participants Adjuvanted placebo on Day 0, saline (0.5mL) on Day 21 Saline: Subcutaneous injection in the upper arm with 0.5ml of saline Adjuvanted placebo: Subcutaneous injection in the upper arm with an emulsion made with 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection	Total n=174 Participants Total of all reporting groups
Age, Continuous	40.02 years STANDARD_DEVIATION 13.691 • n=5 Participants	40.12 years STANDARD_DEVIATION 12.221 • n=7 Participants	41.19 years STANDARD_DEVIATION 12.458 • n=5 Participants	39.07 years STANDARD_DEVIATION 13.074 • n=4 Participants	40.12 years STANDARD_DEVIATION 12.806 • n=21 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	30 Participants n=7 Participants	18 Participants n=5 Participants	13 Participants n=4 Participants	97 Participants n=21 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	27 Participants n=7 Participants	14 Participants n=5 Participants	14 Participants n=4 Participants	77 Participants n=21 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized Black of African descendant	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized White	56 Participants n=5 Participants	54 Participants n=7 Participants	32 Participants n=5 Participants	27 Participants n=4 Participants	169 Participants n=21 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Race/Ethnicity, Customized Unknown or not reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
previous influenza vaccination Never received influenza vaccination	37 Participants n=5 Participants • This baseline measure was only analysed in the FAS population, that is the Full Analysis Set which includes all those subjects that completed vaccination and had at least pre-vaccination immunogenicity data and at least one post-vaccination time point.	29 Participants n=7 Participants • This baseline measure was only analysed in the FAS population, that is the Full Analysis Set which includes all those subjects that completed vaccination and had at least pre-vaccination immunogenicity data and at least one post-vaccination time point.	15 Participants n=5 Participants • This baseline measure was only analysed in the FAS population, that is the Full Analysis Set which includes all those subjects that completed vaccination and had at least pre-vaccination immunogenicity data and at least one post-vaccination time point.	18 Participants n=4 Participants • This baseline measure was only analysed in the FAS population, that is the Full Analysis Set which includes all those subjects that completed vaccination and had at least pre-vaccination immunogenicity data and at least one post-vaccination time point.	99 Participants n=21 Participants • This baseline measure was only analysed in the FAS population, that is the Full Analysis Set which includes all those subjects that completed vaccination and had at least pre-vaccination immunogenicity data and at least one post-vaccination time point.
previous influenza vaccination Received in the previous 2 years	14 Participants n=5 Participants • This baseline measure was only analysed in the FAS population, that is the Full Analysis Set which includes all those subjects that completed vaccination and had at least pre-vaccination immunogenicity data and at least one post-vaccination time point.	20 Participants n=7 Participants • This baseline measure was only analysed in the FAS population, that is the Full Analysis Set which includes all those subjects that completed vaccination and had at least pre-vaccination immunogenicity data and at least one post-vaccination time point.	12 Participants n=5 Participants • This baseline measure was only analysed in the FAS population, that is the Full Analysis Set which includes all those subjects that completed vaccination and had at least pre-vaccination immunogenicity data and at least one post-vaccination time point.	5 Participants n=4 Participants • This baseline measure was only analysed in the FAS population, that is the Full Analysis Set which includes all those subjects that completed vaccination and had at least pre-vaccination immunogenicity data and at least one post-vaccination time point.	51 Participants n=21 Participants • This baseline measure was only analysed in the FAS population, that is the Full Analysis Set which includes all those subjects that completed vaccination and had at least pre-vaccination immunogenicity data and at least one post-vaccination time point.
previous influenza vaccination Received over 2 years ago	7 Participants n=5 Participants • This baseline measure was only analysed in the FAS population, that is the Full Analysis Set which includes all those subjects that completed vaccination and had at least pre-vaccination immunogenicity data and at least one post-vaccination time point.	8 Participants n=7 Participants • This baseline measure was only analysed in the FAS population, that is the Full Analysis Set which includes all those subjects that completed vaccination and had at least pre-vaccination immunogenicity data and at least one post-vaccination time point.	5 Participants n=5 Participants • This baseline measure was only analysed in the FAS population, that is the Full Analysis Set which includes all those subjects that completed vaccination and had at least pre-vaccination immunogenicity data and at least one post-vaccination time point.	4 Participants n=4 Participants • This baseline measure was only analysed in the FAS population, that is the Full Analysis Set which includes all those subjects that completed vaccination and had at least pre-vaccination immunogenicity data and at least one post-vaccination time point.	24 Participants n=21 Participants • This baseline measure was only analysed in the FAS population, that is the Full Analysis Set which includes all those subjects that completed vaccination and had at least pre-vaccination immunogenicity data and at least one post-vaccination time point.
HAI titer at screening HAI≥80 B/Phuket/3073/2013	21 Participants n=5 Participants	16 Participants n=7 Participants	12 Participants n=5 Participants	7 Participants n=4 Participants	56 Participants n=21 Participants
HAI titer at screening HAI≥80 B/Brisbane/60/2008	18 Participants n=5 Participants	19 Participants n=7 Participants	12 Participants n=5 Participants	7 Participants n=4 Participants	56 Participants n=21 Participants
HAI titer at screening HAI≥40 A/Hong Kong/5738/2014 (H3N2)	25 Participants n=5 Participants	26 Participants n=7 Participants	18 Participants n=5 Participants	10 Participants n=4 Participants	79 Participants n=21 Participants
HAI titer at screening HAI≥40 A/Michigan/45/15 (H1N1)	23 Participants n=5 Participants	29 Participants n=7 Participants	16 Participants n=5 Participants	11 Participants n=4 Participants	79 Participants n=21 Participants
HAI titer at screening any of the above	39 Participants n=5 Participants	40 Participants n=7 Participants	26 Participants n=5 Participants	17 Participants n=4 Participants	122 Participants n=21 Participants

PRIMARY outcome

Timeframe: day 0 to day 42

Population: FAS population: Full Analysis Set corresponds to subjects that completed the vaccination successfully and provided samples for immunogenicity analysis for baseline (pre-vaccination) and at least one time point post-vaccination. Only samples with acceptable positive and negative controls were used in the analysis.

Outcome measures

Outcome measures
Measure	2x Non-adjuvanted FLU-v n=58 Participants FLU-v on Day 0 and Day 21 FLU-v: Subcutaneous injection in the upper arm with 500 ug of FLU-v as 0.5ml suspension in 0.01M HCl and 0.01M NaOH	1x Adjuvanted FLU-v n=51 Participants adjuvanted FLU-v on Day 0, saline (0.5mL) on Day 21 adjuvanted FLU-v: Subcutaneous injection in the upper arm with 500ug of FLU-v emulsified in 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Non-adjuvanted Placebo n=32 Participants saline solution (0.5ml) on Day 0 and Day 21 Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Adjuvanted Placebo n=26 Participants Adjuvanted placebo on Day 0, saline (0.5mL) on Day 21 Saline: Subcutaneous injection in the upper arm with 0.5ml of saline Adjuvanted placebo: Subcutaneous injection in the upper arm with an emulsion made with 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection	1x Adjuvanted FLU-v, no Previous Vaccination participants who had not ever previously received an influenza vaccination, and who received adjuvanted FLU-v on Day 0, saline (0.5mL) on Day 21 adjuvanted FLU-v: Subcutaneous injection in the upper arm with 500ug of FLU-v emulsified in 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Combined Placebo, no Previous Vaccination participants who had not ever previously received an influenza vaccination, and who received either non-adjuvanted placebo or adjuvanted placebo Non-adjuvanted Placebo: saline solution (0.5ml) on Day 0 and Day 21 Adjuvanted Placebo: Adjuvanted placebo on Day 0, saline (0.5mL) on Day 21
CD4+ and CD8+ Th1 Cellular Immunogenicity on Day 42 IFN-gamma CD4+	0.5 fold change Interval -0.2 to 1.1	5.9 fold change Interval 1.0 to 10.9	1.0 fold change Interval -0.7 to 2.6	0.2 fold change Interval -0.6 to 1.0	—	—
CD4+ and CD8+ Th1 Cellular Immunogenicity on Day 42 TNF-alpha CD4+	0.0 fold change Interval -0.1 to 0.1	5.0 fold change Interval -10.9 to 20.9	0.0 fold change Interval -0.5 to 0.5	0.0 fold change Interval -0.3 to 0.3	—	—
CD4+ and CD8+ Th1 Cellular Immunogenicity on Day 42 IL-2 CD4+	0.0 fold change Interval -1.1 to 1.1	8.2 fold change Interval -0.4 to 16.7	0.0 fold change Interval -0.4 to 0.4	0.0 fold change Interval -0.1 to 0.1	—	—
CD4+ and CD8+ Th1 Cellular Immunogenicity on Day 42 CD107a CD4+	0.0 fold change Interval -0.4 to 0.4	2.0 fold change Interval 0.3 to 3.7	0.0 fold change Interval -0.5 to 0.5	0.0 fold change Interval -0.2 to 0.2	—	—
CD4+ and CD8+ Th1 Cellular Immunogenicity on Day 42 IFN-gamma CD8+	0.3 fold change Interval -0.1 to 0.6	0.3 fold change Interval -0.2 to 0.7	0.0 fold change Interval -0.1 to 0.1	0.0 fold change Interval -0.3 to 0.3	—	—
CD4+ and CD8+ Th1 Cellular Immunogenicity on Day 42 TNF-alpha CD8+	0.3 fold change Interval 0.0 to 0.6	0.3 fold change Interval -0.6 to 1.3	0.0 fold change Interval -0.6 to 0.6	0.0 fold change Interval -0.1 to 0.1	—	—
CD4+ and CD8+ Th1 Cellular Immunogenicity on Day 42 IL-2 CD8+	0.5 fold change Interval 0.1 to 0.9	0.0 fold change Interval -0.4 to 0.4	0.0 fold change Interval -0.5 to 0.5	0.0 fold change Interval -0.7 to 0.7	—	—
CD4+ and CD8+ Th1 Cellular Immunogenicity on Day 42 CD107a CD8+	0.0 fold change Interval -0.2 to 0.2	0.0 fold change Interval -0.5 to 0.5	0.0 fold change Interval -0.2 to 0.2	0.0 fold change Interval -0.1 to 0.1	—	—

PRIMARY outcome

Timeframe: Day 0 to day 180

Comparison of the TH1 response in the treatment arms compared to placebo from baseline to day 180 following vaccination, calculated as the median fold change in the number of CD4+ and CD8+ T cells positive for IFN-gamma, TNF-alpha, IL-2 and CD107a. Fold change is calculated as the number of cells on day 180 divided by number of cells on day 0.

Outcome measures

Outcome measures
Measure	2x Non-adjuvanted FLU-v n=58 Participants FLU-v on Day 0 and Day 21 FLU-v: Subcutaneous injection in the upper arm with 500 ug of FLU-v as 0.5ml suspension in 0.01M HCl and 0.01M NaOH	1x Adjuvanted FLU-v n=51 Participants adjuvanted FLU-v on Day 0, saline (0.5mL) on Day 21 adjuvanted FLU-v: Subcutaneous injection in the upper arm with 500ug of FLU-v emulsified in 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Non-adjuvanted Placebo n=32 Participants saline solution (0.5ml) on Day 0 and Day 21 Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Adjuvanted Placebo n=26 Participants Adjuvanted placebo on Day 0, saline (0.5mL) on Day 21 Saline: Subcutaneous injection in the upper arm with 0.5ml of saline Adjuvanted placebo: Subcutaneous injection in the upper arm with an emulsion made with 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection	1x Adjuvanted FLU-v, no Previous Vaccination participants who had not ever previously received an influenza vaccination, and who received adjuvanted FLU-v on Day 0, saline (0.5mL) on Day 21 adjuvanted FLU-v: Subcutaneous injection in the upper arm with 500ug of FLU-v emulsified in 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Combined Placebo, no Previous Vaccination participants who had not ever previously received an influenza vaccination, and who received either non-adjuvanted placebo or adjuvanted placebo Non-adjuvanted Placebo: saline solution (0.5ml) on Day 0 and Day 21 Adjuvanted Placebo: Adjuvanted placebo on Day 0, saline (0.5mL) on Day 21
CD4+ and CD8+ Th1 Cellular Immunogenicity on Day 180 IFN-gamma CD4+	0.5 fold change Interval 0.2 to 1.2	4.4 fold change Interval 1.0 to 7.8	0.1 fold change Interval -0.4 to 0.6	0.9 fold change Interval -1.4 to 3.2	—	—
CD4+ and CD8+ Th1 Cellular Immunogenicity on Day 180 TNF-alpha CD4+	0.0 fold change Interval 0.0 to 0.0	0.6 fold change Interval -3.5 to 4.8	0.0 fold change Interval 0.0 to 0.0	0.0 fold change Interval -1.2 to 1.2	—	—
CD4+ and CD8+ Th1 Cellular Immunogenicity on Day 180 IL-2 CD4+	0.2 fold change Interval -0.6 to 1.1	6.5 fold change Interval 2.1 to 10.9	0.0 fold change Interval -0.2 to 0.2	0.0 fold change Interval -0.1 to 0.1	—	—
CD4+ and CD8+ Th1 Cellular Immunogenicity on Day 180 CD107a CD4+	0.6 fold change Interval -0.1 to 1.3	1.0 fold change Interval 0.2 to 1.8	0.0 fold change Interval -0.1 to 0.1	0.6 fold change Interval -0.7 to 1.9	—	—
CD4+ and CD8+ Th1 Cellular Immunogenicity on Day 180 IFN-gamma CD8+	0.0 fold change Interval -0.5 to 0.6	0.2 fold change Interval -0.4 to 0.7	0.0 fold change Interval -0.6 to 0.6	0.0 fold change Interval -0.5 to 0.5	—	—
CD4+ and CD8+ Th1 Cellular Immunogenicity on Day 180 TNF-alpha CD8+	0.1 fold change Interval -0.5 to 0.6	0.2 fold change Interval -0.2 to 0.6	0.1 fold change Interval -0.7 to 0.9	0.1 fold change Interval -1.8 to 1.85	—	—
CD4+ and CD8+ Th1 Cellular Immunogenicity on Day 180 IL-2 CD8+	0.3 fold change Interval -0.3 to 0.7	0.0 fold change Interval -0.6 to 0.6	0.0 fold change Interval -0.3 to 0.3	0.0 fold change Interval -0.4 to 0.4	—	—
CD4+ and CD8+ Th1 Cellular Immunogenicity on Day 180 CD107a CD8+	0.0 fold change Interval -0.4 to 0.4	0.0 fold change Interval -0.9 to 1.5	0.0 fold change Interval -0.5 to 0.5	0.5 fold change Interval -3.2 to 6.8	—	—

PRIMARY outcome

Timeframe: prevaccination, day 42 (21 days after last vaccination) and day 180.

To compare the number of subjects that showed at least a two-fold increase on day 42 and day 180 following vaccination in the number of CD4+and CD8+ T-cells secreting TH1 cytokines in all groups.

Outcome measures

Outcome measures
Measure	2x Non-adjuvanted FLU-v n=58 Participants FLU-v on Day 0 and Day 21 FLU-v: Subcutaneous injection in the upper arm with 500 ug of FLU-v as 0.5ml suspension in 0.01M HCl and 0.01M NaOH	1x Adjuvanted FLU-v n=51 Participants adjuvanted FLU-v on Day 0, saline (0.5mL) on Day 21 adjuvanted FLU-v: Subcutaneous injection in the upper arm with 500ug of FLU-v emulsified in 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Non-adjuvanted Placebo n=32 Participants saline solution (0.5ml) on Day 0 and Day 21 Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Adjuvanted Placebo n=26 Participants Adjuvanted placebo on Day 0, saline (0.5mL) on Day 21 Saline: Subcutaneous injection in the upper arm with 0.5ml of saline Adjuvanted placebo: Subcutaneous injection in the upper arm with an emulsion made with 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection	1x Adjuvanted FLU-v, no Previous Vaccination participants who had not ever previously received an influenza vaccination, and who received adjuvanted FLU-v on Day 0, saline (0.5mL) on Day 21 adjuvanted FLU-v: Subcutaneous injection in the upper arm with 500ug of FLU-v emulsified in 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Combined Placebo, no Previous Vaccination participants who had not ever previously received an influenza vaccination, and who received either non-adjuvanted placebo or adjuvanted placebo Non-adjuvanted Placebo: saline solution (0.5ml) on Day 0 and Day 21 Adjuvanted Placebo: Adjuvanted placebo on Day 0, saline (0.5mL) on Day 21
Percentage of TH1 Cytokine Responders (Responders Defined as Those With >2 Fold Median Increase From Baseline in CD4+ and CD8+ T-cells Positive for Particular Cytokine) IFNg+CD4+ day 42	23 Participants	40 Participants	13 Participants	8 Participants	—	—
Percentage of TH1 Cytokine Responders (Responders Defined as Those With >2 Fold Median Increase From Baseline in CD4+ and CD8+ T-cells Positive for Particular Cytokine) TNFalpha+ CD4+ day 42	16 Participants	33 Participants	12 Participants	9 Participants	—	—
Percentage of TH1 Cytokine Responders (Responders Defined as Those With >2 Fold Median Increase From Baseline in CD4+ and CD8+ T-cells Positive for Particular Cytokine) IL2+ CD4+ day 42	23 Participants	36 Participants	13 Participants	4 Participants	—	—
Percentage of TH1 Cytokine Responders (Responders Defined as Those With >2 Fold Median Increase From Baseline in CD4+ and CD8+ T-cells Positive for Particular Cytokine) CD107a+ CD4+ day 42	22 Participants	26 Participants	8 Participants	4 Participants	—	—
Percentage of TH1 Cytokine Responders (Responders Defined as Those With >2 Fold Median Increase From Baseline in CD4+ and CD8+ T-cells Positive for Particular Cytokine) IFNg+ CD4+ day 180	26 Participants	37 Participants	8 Participants	11 Participants	—	—
Percentage of TH1 Cytokine Responders (Responders Defined as Those With >2 Fold Median Increase From Baseline in CD4+ and CD8+ T-cells Positive for Particular Cytokine) TNFa+ CD4+ day 180	17 Participants	26 Participants	9 Participants	9 Participants	—	—
Percentage of TH1 Cytokine Responders (Responders Defined as Those With >2 Fold Median Increase From Baseline in CD4+ and CD8+ T-cells Positive for Particular Cytokine) IL-2+ CD4+ day 180	26 Participants	39 Participants	13 Participants	9 Participants	—	—
Percentage of TH1 Cytokine Responders (Responders Defined as Those With >2 Fold Median Increase From Baseline in CD4+ and CD8+ T-cells Positive for Particular Cytokine) CD107a+ CD4+ day 180	24 Participants	21 Participants	5 Participants	8 Participants	—	—
Percentage of TH1 Cytokine Responders (Responders Defined as Those With >2 Fold Median Increase From Baseline in CD4+ and CD8+ T-cells Positive for Particular Cytokine) IFN-gamma day 42 CD8+	22 Participants	16 Participants	9 Participants	4 Participants	—	—
Percentage of TH1 Cytokine Responders (Responders Defined as Those With >2 Fold Median Increase From Baseline in CD4+ and CD8+ T-cells Positive for Particular Cytokine) TNF-alpha day 42 CD8+	22 Participants	23 Participants	10 Participants	6 Participants	—	—
Percentage of TH1 Cytokine Responders (Responders Defined as Those With >2 Fold Median Increase From Baseline in CD4+ and CD8+ T-cells Positive for Particular Cytokine) IL2 day 42 CD8+	25 Participants	17 Participants	9 Participants	8 Participants	—	—
Percentage of TH1 Cytokine Responders (Responders Defined as Those With >2 Fold Median Increase From Baseline in CD4+ and CD8+ T-cells Positive for Particular Cytokine) CD107a day 42 CD8+	23 Participants	19 Participants	5 Participants	2 Participants	—	—
Percentage of TH1 Cytokine Responders (Responders Defined as Those With >2 Fold Median Increase From Baseline in CD4+ and CD8+ T-cells Positive for Particular Cytokine) IFN-gamma day 180 CD8+	27 Participants	22 Participants	13 Participants	7 Participants	—	—
Percentage of TH1 Cytokine Responders (Responders Defined as Those With >2 Fold Median Increase From Baseline in CD4+ and CD8+ T-cells Positive for Particular Cytokine) TNF-alpha day 180 CD8+	21 Participants	18 Participants	14 Participants	12 Participants	—	—
Percentage of TH1 Cytokine Responders (Responders Defined as Those With >2 Fold Median Increase From Baseline in CD4+ and CD8+ T-cells Positive for Particular Cytokine) IL2 day 180 CD8+	11 Participants	16 Participants	8 Participants	5 Participants	—	—
Percentage of TH1 Cytokine Responders (Responders Defined as Those With >2 Fold Median Increase From Baseline in CD4+ and CD8+ T-cells Positive for Particular Cytokine) CD107a day 180 CD8+	19 Participants	24 Participants	8 Participants	8 Participants	—	—

PRIMARY outcome

Timeframe: day 0 to day 42 and day 180

Population: FAS: Full Analysis Set corresponds to subjects that completed the vaccination successfully and provided samples for immunogenicity analysis for baseline (pre-vaccination) and at least one time point post-vaccination. Only samples with acceptable positive and negative controls were used in the analysis.

To compare the number of subjects identified as responders for cytokine markers as determined by MIMOSA analysis (Responders based on a false discovery rate derived P-value \<0.05).

Outcome measures

Outcome measures
Measure	2x Non-adjuvanted FLU-v n=58 Participants FLU-v on Day 0 and Day 21 FLU-v: Subcutaneous injection in the upper arm with 500 ug of FLU-v as 0.5ml suspension in 0.01M HCl and 0.01M NaOH	1x Adjuvanted FLU-v n=51 Participants adjuvanted FLU-v on Day 0, saline (0.5mL) on Day 21 adjuvanted FLU-v: Subcutaneous injection in the upper arm with 500ug of FLU-v emulsified in 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Non-adjuvanted Placebo n=32 Participants saline solution (0.5ml) on Day 0 and Day 21 Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Adjuvanted Placebo n=26 Participants Adjuvanted placebo on Day 0, saline (0.5mL) on Day 21 Saline: Subcutaneous injection in the upper arm with 0.5ml of saline Adjuvanted placebo: Subcutaneous injection in the upper arm with an emulsion made with 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection	1x Adjuvanted FLU-v, no Previous Vaccination participants who had not ever previously received an influenza vaccination, and who received adjuvanted FLU-v on Day 0, saline (0.5mL) on Day 21 adjuvanted FLU-v: Subcutaneous injection in the upper arm with 500ug of FLU-v emulsified in 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Combined Placebo, no Previous Vaccination participants who had not ever previously received an influenza vaccination, and who received either non-adjuvanted placebo or adjuvanted placebo Non-adjuvanted Placebo: saline solution (0.5ml) on Day 0 and Day 21 Adjuvanted Placebo: Adjuvanted placebo on Day 0, saline (0.5mL) on Day 21
Percentage of CD4+ and CD8+ TH1 Cytokine Responders Determined by Mixture Models for Single-cell Assays (MIMOSA) IFN-gamma day 42 CD4+	7 Participants	38 Participants	1 Participants	2 Participants	—	—
Percentage of CD4+ and CD8+ TH1 Cytokine Responders Determined by Mixture Models for Single-cell Assays (MIMOSA) TNF-alpha day 42 CD4+	3 Participants	22 Participants	1 Participants	0 Participants	—	—
Percentage of CD4+ and CD8+ TH1 Cytokine Responders Determined by Mixture Models for Single-cell Assays (MIMOSA) IL-2 day 42 CD4+	1 Participants	28 Participants	1 Participants	0 Participants	—	—
Percentage of CD4+ and CD8+ TH1 Cytokine Responders Determined by Mixture Models for Single-cell Assays (MIMOSA) CD107a day 42 CD4+	1 Participants	5 Participants	1 Participants	0 Participants	—	—
Percentage of CD4+ and CD8+ TH1 Cytokine Responders Determined by Mixture Models for Single-cell Assays (MIMOSA) IFN-gamma day 180 CD4+	8 Participants	31 Participants	2 Participants	1 Participants	—	—
Percentage of CD4+ and CD8+ TH1 Cytokine Responders Determined by Mixture Models for Single-cell Assays (MIMOSA) TNF-alpha day 180 CD4+	2 Participants	12 Participants	1 Participants	0 Participants	—	—
Percentage of CD4+ and CD8+ TH1 Cytokine Responders Determined by Mixture Models for Single-cell Assays (MIMOSA) IL-2 day 180 CD4+	1 Participants	28 Participants	1 Participants	0 Participants	—	—
Percentage of CD4+ and CD8+ TH1 Cytokine Responders Determined by Mixture Models for Single-cell Assays (MIMOSA) CD107a day 180 CD4+	2 Participants	4 Participants	2 Participants	1 Participants	—	—
Percentage of CD4+ and CD8+ TH1 Cytokine Responders Determined by Mixture Models for Single-cell Assays (MIMOSA) IFN-gamma day 42 CD8+	3 Participants	3 Participants	0 Participants	0 Participants	—	—
Percentage of CD4+ and CD8+ TH1 Cytokine Responders Determined by Mixture Models for Single-cell Assays (MIMOSA) TNF-alpha day 42 CD8+	0 Participants	1 Participants	0 Participants	0 Participants	—	—
Percentage of CD4+ and CD8+ TH1 Cytokine Responders Determined by Mixture Models for Single-cell Assays (MIMOSA) IL2 day 42 CD8+	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Percentage of CD4+ and CD8+ TH1 Cytokine Responders Determined by Mixture Models for Single-cell Assays (MIMOSA) CD107a day 42 CD8+	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Percentage of CD4+ and CD8+ TH1 Cytokine Responders Determined by Mixture Models for Single-cell Assays (MIMOSA) IFN-gamma day 180 CD8+	4 Participants	3 Participants	0 Participants	1 Participants	—	—
Percentage of CD4+ and CD8+ TH1 Cytokine Responders Determined by Mixture Models for Single-cell Assays (MIMOSA) TNF-alpha day 180 CD8+	1 Participants	1 Participants	0 Participants	0 Participants	—	—
Percentage of CD4+ and CD8+ TH1 Cytokine Responders Determined by Mixture Models for Single-cell Assays (MIMOSA) IL2 day 180 CD8+	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Percentage of CD4+ and CD8+ TH1 Cytokine Responders Determined by Mixture Models for Single-cell Assays (MIMOSA) CD107a day 180 CD8+	0 Participants	1 Participants	0 Participants	0 Participants	—	—

PRIMARY outcome

Timeframe: day 0 to day 42, day 0 to day 180

Median fold change in IFN-gamma secretion from PBMCs stimulated in vitro with FLU-v antigens. IFN-gamma secretion was measured by ELISA.Fold change was measured as secretion on day 42 divided by secretion on day 0, and secretion on day 180 divided by secretion on day 0.

Outcome measures

Outcome measures
Measure	2x Non-adjuvanted FLU-v n=58 Participants FLU-v on Day 0 and Day 21 FLU-v: Subcutaneous injection in the upper arm with 500 ug of FLU-v as 0.5ml suspension in 0.01M HCl and 0.01M NaOH	1x Adjuvanted FLU-v n=51 Participants adjuvanted FLU-v on Day 0, saline (0.5mL) on Day 21 adjuvanted FLU-v: Subcutaneous injection in the upper arm with 500ug of FLU-v emulsified in 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Non-adjuvanted Placebo n=32 Participants saline solution (0.5ml) on Day 0 and Day 21 Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Adjuvanted Placebo n=26 Participants Adjuvanted placebo on Day 0, saline (0.5mL) on Day 21 Saline: Subcutaneous injection in the upper arm with 0.5ml of saline Adjuvanted placebo: Subcutaneous injection in the upper arm with an emulsion made with 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection	1x Adjuvanted FLU-v, no Previous Vaccination participants who had not ever previously received an influenza vaccination, and who received adjuvanted FLU-v on Day 0, saline (0.5mL) on Day 21 adjuvanted FLU-v: Subcutaneous injection in the upper arm with 500ug of FLU-v emulsified in 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Combined Placebo, no Previous Vaccination participants who had not ever previously received an influenza vaccination, and who received either non-adjuvanted placebo or adjuvanted placebo Non-adjuvanted Placebo: saline solution (0.5ml) on Day 0 and Day 21 Adjuvanted Placebo: Adjuvanted placebo on Day 0, saline (0.5mL) on Day 21
IFN-gamma Responses Measured by ELISA Day 42	0.8 fold change Interval -2.3 to 3.9	59.0 fold change Interval 33.3 to 84.7	1.0 fold change Interval -0.8 to 2.8	1.0 fold change Interval -2.4 to 4.4	—	—
IFN-gamma Responses Measured by ELISA Day 180	1.0 fold change Interval 0.7 to 1.3	27.3 fold change Interval 5.2 to 49.4	1.0 fold change Interval -1.4 to 3.4	0.9 fold change Interval 0.0 to 1.9	—	—

PRIMARY outcome

Timeframe: prevaccination (day 0) to postvaccination (day 42 and day 180)

Population: FAS: Full Analysis Set including subjects that completed vaccination and provided immunogenicity samples for prevaccination and at least one post-vaccination time point (day 42 or day 180). Only samples that meet the acceptance criteria based on the positive and negative controls were used in the analysis.

Responders were defined as subjects having at least a two-fold increase in the amount of IFNg secreted on day 42 and day 180 compared the amount secreted on day 0. IFNg was measured by ELISA

Outcome measures

Outcome measures
Measure	2x Non-adjuvanted FLU-v n=58 Participants FLU-v on Day 0 and Day 21 FLU-v: Subcutaneous injection in the upper arm with 500 ug of FLU-v as 0.5ml suspension in 0.01M HCl and 0.01M NaOH	1x Adjuvanted FLU-v n=51 Participants adjuvanted FLU-v on Day 0, saline (0.5mL) on Day 21 adjuvanted FLU-v: Subcutaneous injection in the upper arm with 500ug of FLU-v emulsified in 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Non-adjuvanted Placebo n=32 Participants saline solution (0.5ml) on Day 0 and Day 21 Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Adjuvanted Placebo n=26 Participants Adjuvanted placebo on Day 0, saline (0.5mL) on Day 21 Saline: Subcutaneous injection in the upper arm with 0.5ml of saline Adjuvanted placebo: Subcutaneous injection in the upper arm with an emulsion made with 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection	1x Adjuvanted FLU-v, no Previous Vaccination participants who had not ever previously received an influenza vaccination, and who received adjuvanted FLU-v on Day 0, saline (0.5mL) on Day 21 adjuvanted FLU-v: Subcutaneous injection in the upper arm with 500ug of FLU-v emulsified in 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Combined Placebo, no Previous Vaccination participants who had not ever previously received an influenza vaccination, and who received either non-adjuvanted placebo or adjuvanted placebo Non-adjuvanted Placebo: saline solution (0.5ml) on Day 0 and Day 21 Adjuvanted Placebo: Adjuvanted placebo on Day 0, saline (0.5mL) on Day 21
Percentage of Responders on Day 42 and Day 180 for IFNgamma Secretion by PBMCs day 42	28 Participants	42 Participants	10 Participants	9 Participants	—	—
Percentage of Responders on Day 42 and Day 180 for IFNgamma Secretion by PBMCs day 180	22 Participants	40 Participants	13 Participants	11 Participants	—	—

PRIMARY outcome

Timeframe: until 21 days after the last dosing of the study vaccine

Population: Safety Population: All subjects that received at least one vaccination

To evaluate the solicited AEs in all subjects

Outcome measures

Outcome measures
Measure	2x Non-adjuvanted FLU-v n=58 Participants FLU-v on Day 0 and Day 21 FLU-v: Subcutaneous injection in the upper arm with 500 ug of FLU-v as 0.5ml suspension in 0.01M HCl and 0.01M NaOH	1x Adjuvanted FLU-v n=57 Participants adjuvanted FLU-v on Day 0, saline (0.5mL) on Day 21 adjuvanted FLU-v: Subcutaneous injection in the upper arm with 500ug of FLU-v emulsified in 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Non-adjuvanted Placebo n=32 Participants saline solution (0.5ml) on Day 0 and Day 21 Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Adjuvanted Placebo n=27 Participants Adjuvanted placebo on Day 0, saline (0.5mL) on Day 21 Saline: Subcutaneous injection in the upper arm with 0.5ml of saline Adjuvanted placebo: Subcutaneous injection in the upper arm with an emulsion made with 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection	1x Adjuvanted FLU-v, no Previous Vaccination participants who had not ever previously received an influenza vaccination, and who received adjuvanted FLU-v on Day 0, saline (0.5mL) on Day 21 adjuvanted FLU-v: Subcutaneous injection in the upper arm with 500ug of FLU-v emulsified in 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Combined Placebo, no Previous Vaccination participants who had not ever previously received an influenza vaccination, and who received either non-adjuvanted placebo or adjuvanted placebo Non-adjuvanted Placebo: saline solution (0.5ml) on Day 0 and Day 21 Adjuvanted Placebo: Adjuvanted placebo on Day 0, saline (0.5mL) on Day 21
Solicited AEs All solicited AEs	275 Events	485 Events	149 Events	147 Events	—	—
Solicited AEs Solicited AEs unrelated to vaccination	12 Events	13 Events	8 Events	0 Events	—	—
Solicited AEs Solicited AEs unlikely related to vaccination	72 Events	74 Events	71 Events	34 Events	—	—
Solicited AEs Solicited AEs possibly related to vaccination	108 Events	134 Events	64 Events	39 Events	—	—
Solicited AEs Solicited AEs probably related to vaccination	16 Events	16 Events	0 Events	12 Events	—	—
Solicited AEs Solicited AEs definately related to vaccination	67 Events	248 Events	6 Events	62 Events	—	—
Solicited AEs Mild solicited AEs	210 Events	339 Events	124 Events	111 Events	—	—
Solicited AEs Moderate solicited AEs	59 Events	132 Events	24 Events	34 Events	—	—
Solicited AEs Severe solicited AEs	6 Events	14 Events	1 Events	2 Events	—	—

SECONDARY outcome

Timeframe: prevaccination, day 42 (21 days after last vaccination) and day 180.

To evaluate the IgG levels as a measure of antibody responses to FLU-v on day 0 (baseline) and on days 42 and 180 following FLU-v vaccination. IgG antibodies were measured by ELISA. The geometric mean for each treatment group was provided.

Outcome measures

Outcome measures
Measure	2x Non-adjuvanted FLU-v n=58 Participants FLU-v on Day 0 and Day 21 FLU-v: Subcutaneous injection in the upper arm with 500 ug of FLU-v as 0.5ml suspension in 0.01M HCl and 0.01M NaOH	1x Adjuvanted FLU-v n=51 Participants adjuvanted FLU-v on Day 0, saline (0.5mL) on Day 21 adjuvanted FLU-v: Subcutaneous injection in the upper arm with 500ug of FLU-v emulsified in 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Non-adjuvanted Placebo n=32 Participants saline solution (0.5ml) on Day 0 and Day 21 Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Adjuvanted Placebo n=26 Participants Adjuvanted placebo on Day 0, saline (0.5mL) on Day 21 Saline: Subcutaneous injection in the upper arm with 0.5ml of saline Adjuvanted placebo: Subcutaneous injection in the upper arm with an emulsion made with 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection	1x Adjuvanted FLU-v, no Previous Vaccination participants who had not ever previously received an influenza vaccination, and who received adjuvanted FLU-v on Day 0, saline (0.5mL) on Day 21 adjuvanted FLU-v: Subcutaneous injection in the upper arm with 500ug of FLU-v emulsified in 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Combined Placebo, no Previous Vaccination participants who had not ever previously received an influenza vaccination, and who received either non-adjuvanted placebo or adjuvanted placebo Non-adjuvanted Placebo: saline solution (0.5ml) on Day 0 and Day 21 Adjuvanted Placebo: Adjuvanted placebo on Day 0, saline (0.5mL) on Day 21
Antibody Responses to FLU-v day 0	499.11 IgG ng/ml Standard Error 103.19	362.86 IgG ng/ml Standard Error 82.93	331.16 IgG ng/ml Standard Error 59.00	371.89 IgG ng/ml Standard Error 67.47	—	—
Antibody Responses to FLU-v day 42	2593.02 IgG ng/ml Standard Error 1652.34	8740.48 IgG ng/ml Standard Error 2432.90	336.37 IgG ng/ml Standard Error 58.92	381.17 IgG ng/ml Standard Error 61.18	—	—
Antibody Responses to FLU-v day 180	1276.34 IgG ng/ml Standard Error 344.52	4769.16 IgG ng/ml Standard Error 1131.67	344.88 IgG ng/ml Standard Error 66.57	387.26 IgG ng/ml Standard Error 61.48	—	—

SECONDARY outcome

Timeframe: prevaccination, day 42 (21 days after last vaccination) and day 180.

Population: FAS: Full Analysis Set includes all subjects that completed the vaccination successfully and provided samples for immunogenicity analysis at baseline (Pre-vaccination) and at least one time point post-vaccination. Only samples that met the acceptance criteria based on positive and negative controls were used in the analysis

To evaluate the level of TH2 cytokines (IL-4) from baseline in all groups 42 and 180 days following FLU-v vaccination.

Outcome measures

Outcome measures
Measure	2x Non-adjuvanted FLU-v n=58 Participants FLU-v on Day 0 and Day 21 FLU-v: Subcutaneous injection in the upper arm with 500 ug of FLU-v as 0.5ml suspension in 0.01M HCl and 0.01M NaOH	1x Adjuvanted FLU-v n=51 Participants adjuvanted FLU-v on Day 0, saline (0.5mL) on Day 21 adjuvanted FLU-v: Subcutaneous injection in the upper arm with 500ug of FLU-v emulsified in 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Non-adjuvanted Placebo n=32 Participants saline solution (0.5ml) on Day 0 and Day 21 Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Adjuvanted Placebo n=26 Participants Adjuvanted placebo on Day 0, saline (0.5mL) on Day 21 Saline: Subcutaneous injection in the upper arm with 0.5ml of saline Adjuvanted placebo: Subcutaneous injection in the upper arm with an emulsion made with 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection	1x Adjuvanted FLU-v, no Previous Vaccination participants who had not ever previously received an influenza vaccination, and who received adjuvanted FLU-v on Day 0, saline (0.5mL) on Day 21 adjuvanted FLU-v: Subcutaneous injection in the upper arm with 500ug of FLU-v emulsified in 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Combined Placebo, no Previous Vaccination participants who had not ever previously received an influenza vaccination, and who received either non-adjuvanted placebo or adjuvanted placebo Non-adjuvanted Placebo: saline solution (0.5ml) on Day 0 and Day 21 Adjuvanted Placebo: Adjuvanted placebo on Day 0, saline (0.5mL) on Day 21
Th2 Cytokine Responses (IL-4) IL-4+CD4+ cells day 42	NA percentage of responders Below level of detection	NA percentage of responders below level of detection	NA percentage of responders below level of detection	NA percentage of responders below level of detection	—	—
Th2 Cytokine Responses (IL-4) IL-4+ CD8+ cells day 42	NA percentage of responders below level of detection	NA percentage of responders below level of detection	NA percentage of responders below level of detection	NA percentage of responders below level of detection	—	—
Th2 Cytokine Responses (IL-4) IL-4+ CD4+ cells day 180	NA percentage of responders below level of detection	NA percentage of responders below level of detection	NA percentage of responders below level of detection	NA percentage of responders below level of detection	—	—
Th2 Cytokine Responses (IL-4) IL-4+ CD8+ cells day 180	NA percentage of responders below level of detection	NA percentage of responders below level of detection	NA percentage of responders below level of detection	NA percentage of responders below level of detection	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: From the start of the vacciantion until study completion for each subject, approximately no more than 7 months

Population: Safety Population: all subjects that received at least one vaccination

To evaluate unsolicited AEs and SAEs in all subjects

Outcome measures

Outcome measures
Measure	2x Non-adjuvanted FLU-v n=58 Participants FLU-v on Day 0 and Day 21 FLU-v: Subcutaneous injection in the upper arm with 500 ug of FLU-v as 0.5ml suspension in 0.01M HCl and 0.01M NaOH	1x Adjuvanted FLU-v n=57 Participants adjuvanted FLU-v on Day 0, saline (0.5mL) on Day 21 adjuvanted FLU-v: Subcutaneous injection in the upper arm with 500ug of FLU-v emulsified in 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Non-adjuvanted Placebo n=32 Participants saline solution (0.5ml) on Day 0 and Day 21 Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Adjuvanted Placebo n=27 Participants Adjuvanted placebo on Day 0, saline (0.5mL) on Day 21 Saline: Subcutaneous injection in the upper arm with 0.5ml of saline Adjuvanted placebo: Subcutaneous injection in the upper arm with an emulsion made with 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection	1x Adjuvanted FLU-v, no Previous Vaccination participants who had not ever previously received an influenza vaccination, and who received adjuvanted FLU-v on Day 0, saline (0.5mL) on Day 21 adjuvanted FLU-v: Subcutaneous injection in the upper arm with 500ug of FLU-v emulsified in 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Combined Placebo, no Previous Vaccination participants who had not ever previously received an influenza vaccination, and who received either non-adjuvanted placebo or adjuvanted placebo Non-adjuvanted Placebo: saline solution (0.5ml) on Day 0 and Day 21 Adjuvanted Placebo: Adjuvanted placebo on Day 0, saline (0.5mL) on Day 21
Unsolicited AEs and SAEs All unsolicited AEs	19 events	24 events	13 events	9 events	—	—
Unsolicited AEs and SAEs Unsolicited AEs unrelated to the vaccine	8 events	11 events	5 events	5 events	—	—
Unsolicited AEs and SAEs Unsolicited AEs unlikely related to the vacccine	4 events	8 events	7 events	3 events	—	—
Unsolicited AEs and SAEs Unsolicited AEs possibly related to the vacccine	5 events	4 events	1 events	1 events	—	—
Unsolicited AEs and SAEs Unsolicited AEs probably related to the vaccine	0 events	0 events	0 events	0 events	—	—
Unsolicited AEs and SAEs Unsolicited AEs definately related to the vaccine	2 events	1 events	0 events	0 events	—	—
Unsolicited AEs and SAEs Mild unsolicited AEs	15 events	16 events	10 events	4 events	—	—
Unsolicited AEs and SAEs Moderate unsolicited AEs	3 events	4 events	1 events	5 events	—	—
Unsolicited AEs and SAEs Severe unsolicited AEs	1 events	3 events	2 events	0 events	—	—
Unsolicited AEs and SAEs Severe Adverse Events	2 events	3 events	0 events	0 events	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: For up to 4 months during the influenza season

Population: FAS: Full Analysis Set includes subjects that completed vaccination and provided samples to measure immunogenicity data prevaccination (day 0) and at least one time point post vaccination (day 42 or day 180)

During the influenza season (Dec 2016 to March 2017), fully vaccinated subjects will contact the trial center immediately if they feel unwell for 24h, with a sudden onset of flu-like symptoms. The medical staff will arrange for a nasopharyngeal swab to be performed if the subject has at least one respiratory (cough, sore throat, shortness of breath, runny nose, stuffy nose, sneezing and earache) and one systemic symptom (fever, malaise, headache and myalgia (muscle and joint pain). Swabs should be taken from the reported subjects within 3 days from the trial center being contacted or within 4 days of the onset of symptoms, whatever time is shorter.

Outcome measures

Outcome measures
Measure	2x Non-adjuvanted FLU-v n=58 Participants FLU-v on Day 0 and Day 21 FLU-v: Subcutaneous injection in the upper arm with 500 ug of FLU-v as 0.5ml suspension in 0.01M HCl and 0.01M NaOH	1x Adjuvanted FLU-v n=51 Participants adjuvanted FLU-v on Day 0, saline (0.5mL) on Day 21 adjuvanted FLU-v: Subcutaneous injection in the upper arm with 500ug of FLU-v emulsified in 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Non-adjuvanted Placebo n=32 Participants saline solution (0.5ml) on Day 0 and Day 21 Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Adjuvanted Placebo n=26 Participants Adjuvanted placebo on Day 0, saline (0.5mL) on Day 21 Saline: Subcutaneous injection in the upper arm with 0.5ml of saline Adjuvanted placebo: Subcutaneous injection in the upper arm with an emulsion made with 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection	1x Adjuvanted FLU-v, no Previous Vaccination participants who had not ever previously received an influenza vaccination, and who received adjuvanted FLU-v on Day 0, saline (0.5mL) on Day 21 adjuvanted FLU-v: Subcutaneous injection in the upper arm with 500ug of FLU-v emulsified in 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Combined Placebo, no Previous Vaccination participants who had not ever previously received an influenza vaccination, and who received either non-adjuvanted placebo or adjuvanted placebo Non-adjuvanted Placebo: saline solution (0.5ml) on Day 0 and Day 21 Adjuvanted Placebo: Adjuvanted placebo on Day 0, saline (0.5mL) on Day 21
Percentage of Participants Who Tested Positive for Influenza Strains positive for influenza A strains	5.2 percentage of subjects	7.8 percentage of subjects	6.3 percentage of subjects	19.2 percentage of subjects	—	—
Percentage of Participants Who Tested Positive for Influenza Strains positive for influenza B strains	0.0 percentage of subjects	2.0 percentage of subjects	3.1 percentage of subjects	3.8 percentage of subjects	—	—
Percentage of Participants Who Tested Positive for Influenza Strains positive for influenza H1 strains	0.0 percentage of subjects	0.0 percentage of subjects	0.0 percentage of subjects	0.0 percentage of subjects	—	—
Percentage of Participants Who Tested Positive for Influenza Strains positive for influenza H3 strains	5.2 percentage of subjects	7.8 percentage of subjects	6.3 percentage of subjects	19.2 percentage of subjects	—	—
Percentage of Participants Who Tested Positive for Influenza Strains positive for any influenza strain	5.2 percentage of subjects	9.8 percentage of subjects	9.4 percentage of subjects	23.1 percentage of subjects	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Symptoms experienced during an influenza infection episode, approximately 7-10 days.

Population: FAS: Full Analysis Set includes subjects that completed vaccination and provided samples to assess immunogenicity at pre-vaccination (day 0) and at least one post-vaccination time point (day 42 or day 180).

Subjects recorded daily influenza symptoms from December 2016 up to March 2017. Subjects with a sudden onset of at least one respiratory and one systemic symptom were swabbed. If the results were positive for influenza then the symptoms were included in the analysis. The duration of symptoms was recorded as the number of symptomatic days during the influenza episode. Fever (≥38oC), malaise, headache, myalgia (muscle and joint pain), cough, sore throat, shortness of breath, runny nose, stuffy nose, sneezing and earache were scored on a severity scale of 0 to 3 (0: no symptom, 1: mild, 2: moderate, 3: severe). The daily severity score was the sum of the severity score for all symptoms listed above on a single day. The total score was the sum of all daily scores during the influenza episode. The peak score was the highest daily score during the influenza episode. The average score was the total score divided by the number of days the influenza episode lasted.

Outcome measures

Outcome measures
Measure	2x Non-adjuvanted FLU-v n=58 Participants FLU-v on Day 0 and Day 21 FLU-v: Subcutaneous injection in the upper arm with 500 ug of FLU-v as 0.5ml suspension in 0.01M HCl and 0.01M NaOH	1x Adjuvanted FLU-v n=51 Participants adjuvanted FLU-v on Day 0, saline (0.5mL) on Day 21 adjuvanted FLU-v: Subcutaneous injection in the upper arm with 500ug of FLU-v emulsified in 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Non-adjuvanted Placebo n=32 Participants saline solution (0.5ml) on Day 0 and Day 21 Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Adjuvanted Placebo n=26 Participants Adjuvanted placebo on Day 0, saline (0.5mL) on Day 21 Saline: Subcutaneous injection in the upper arm with 0.5ml of saline Adjuvanted placebo: Subcutaneous injection in the upper arm with an emulsion made with 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection	1x Adjuvanted FLU-v, no Previous Vaccination participants who had not ever previously received an influenza vaccination, and who received adjuvanted FLU-v on Day 0, saline (0.5mL) on Day 21 adjuvanted FLU-v: Subcutaneous injection in the upper arm with 500ug of FLU-v emulsified in 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Combined Placebo, no Previous Vaccination participants who had not ever previously received an influenza vaccination, and who received either non-adjuvanted placebo or adjuvanted placebo Non-adjuvanted Placebo: saline solution (0.5ml) on Day 0 and Day 21 Adjuvanted Placebo: Adjuvanted placebo on Day 0, saline (0.5mL) on Day 21
Severity of Symptoms in RT-PCR Influenza-confirmed Subjects. total symptom score	113.67 units on a scale Standard Error 50.87	30.80 units on a scale Standard Error 8.46	57.33 units on a scale Standard Error 13.28	55.17 units on a scale Standard Error 12.96	—	—
Severity of Symptoms in RT-PCR Influenza-confirmed Subjects. total symptom peak	17.67 units on a scale Standard Error 3.48	13.80 units on a scale Standard Error 1.16	15.33 units on a scale Standard Error 1.20	16.50 units on a scale Standard Error 2.73	—	—
Severity of Symptoms in RT-PCR Influenza-confirmed Subjects. average severity symptom score	10.63 units on a scale Standard Error 1.13	10.92 units on a scale Standard Error 1.61	8.59 units on a scale Standard Error 1.44	13.76 units on a scale Standard Error 2.12	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: During an influenza episode

Population: FAS population: subjects that completed the vaccination and had immunogenicity data at pre-vaccination and at least one time point post-vaccination.

Outcome measures

Outcome measures
Measure	2x Non-adjuvanted FLU-v n=58 Participants FLU-v on Day 0 and Day 21 FLU-v: Subcutaneous injection in the upper arm with 500 ug of FLU-v as 0.5ml suspension in 0.01M HCl and 0.01M NaOH	1x Adjuvanted FLU-v n=51 Participants adjuvanted FLU-v on Day 0, saline (0.5mL) on Day 21 adjuvanted FLU-v: Subcutaneous injection in the upper arm with 500ug of FLU-v emulsified in 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Non-adjuvanted Placebo n=32 Participants saline solution (0.5ml) on Day 0 and Day 21 Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Adjuvanted Placebo n=26 Participants Adjuvanted placebo on Day 0, saline (0.5mL) on Day 21 Saline: Subcutaneous injection in the upper arm with 0.5ml of saline Adjuvanted placebo: Subcutaneous injection in the upper arm with an emulsion made with 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection	1x Adjuvanted FLU-v, no Previous Vaccination participants who had not ever previously received an influenza vaccination, and who received adjuvanted FLU-v on Day 0, saline (0.5mL) on Day 21 adjuvanted FLU-v: Subcutaneous injection in the upper arm with 500ug of FLU-v emulsified in 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Combined Placebo, no Previous Vaccination participants who had not ever previously received an influenza vaccination, and who received either non-adjuvanted placebo or adjuvanted placebo Non-adjuvanted Placebo: saline solution (0.5ml) on Day 0 and Day 21 Adjuvanted Placebo: Adjuvanted placebo on Day 0, saline (0.5mL) on Day 21
Duration of Influenza Symptoms in RT-PCR Confirmed Infected Subjects.	11.67 days Standard Error 5.61	3.20 days Standard Error 1.07	7.33 days Standard Error 2.19	4.00 days Standard Error 0.86	—	—

POST_HOC outcome

Timeframe: day 0 to day 42, day 0 to day 180

Population: FAS

Antigen specific responders in FLU-v vaccinated arms compared to combined placebo group, grouped into those who had recieved an influenza vaccination within the previous 2 years and those who had not ever received a previous influenza vaccination. Responders were defined as those having a ≥2-fold increase in response in IFN-gamma secretion by peripheral blood mononuclear cells from day 0 to day 42 or day 180, as measured by enzyme-linked immunosorbent assay. The combined placebo group includes participants randomly assigned to adjuvanted placebo and those assigned to nonadjuvanted placebo.

Outcome measures

Outcome measures
Measure	2x Non-adjuvanted FLU-v n=14 Participants FLU-v on Day 0 and Day 21 FLU-v: Subcutaneous injection in the upper arm with 500 ug of FLU-v as 0.5ml suspension in 0.01M HCl and 0.01M NaOH	1x Adjuvanted FLU-v n=18 Participants adjuvanted FLU-v on Day 0, saline (0.5mL) on Day 21 adjuvanted FLU-v: Subcutaneous injection in the upper arm with 500ug of FLU-v emulsified in 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Non-adjuvanted Placebo n=16 Participants saline solution (0.5ml) on Day 0 and Day 21 Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Adjuvanted Placebo n=37 Participants Adjuvanted placebo on Day 0, saline (0.5mL) on Day 21 Saline: Subcutaneous injection in the upper arm with 0.5ml of saline Adjuvanted placebo: Subcutaneous injection in the upper arm with an emulsion made with 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection	1x Adjuvanted FLU-v, no Previous Vaccination n=25 Participants participants who had not ever previously received an influenza vaccination, and who received adjuvanted FLU-v on Day 0, saline (0.5mL) on Day 21 adjuvanted FLU-v: Subcutaneous injection in the upper arm with 500ug of FLU-v emulsified in 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Combined Placebo, no Previous Vaccination n=33 Participants participants who had not ever previously received an influenza vaccination, and who received either non-adjuvanted placebo or adjuvanted placebo Non-adjuvanted Placebo: saline solution (0.5ml) on Day 0 and Day 21 Adjuvanted Placebo: Adjuvanted placebo on Day 0, saline (0.5mL) on Day 21
Effect of Influenza Vaccination in Previous 2 Years on Immunogenicity Responders on day 42	6 Participants	13 Participants	6 Participants	20 Participants	21 Participants	10 Participants
Effect of Influenza Vaccination in Previous 2 Years on Immunogenicity Responders on day 180	5 Participants	13 Participants	8 Participants	15 Participants	21 Participants	15 Participants

Adverse Events

2x Non-adjuvanted FLU-v

Serious events: 2 serious events

Other events: 41 other events

Deaths: 0 deaths

1x Adjuvanted FLU-v

Serious events: 2 serious events

Other events: 50 other events

Deaths: 0 deaths

Non-adjuvanted Placebo

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Adjuvanted Placebo

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	2x Non-adjuvanted FLU-v n=58 participants at risk FLU-v on Day 0 and Day 21 FLU-v: Subcutaneous injection in the upper arm with 500 ug of FLU-v as 0.5ml suspension in 0.01M HCl and 0.01M NaOH	1x Adjuvanted FLU-v n=57 participants at risk adjuvanted FLU-v on Day 0, saline (0.5mL) on Day 21 adjuvanted FLU-v: Subcutaneous injection in the upper arm with 500ug of FLU-v emulsified in 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Non-adjuvanted Placebo n=32 participants at risk saline solution (0.5ml) on Day 0 and Day 21 Saline: Subcutaneous injection in the upper arm with 0.5ml of saline	Adjuvanted Placebo n=27 participants at risk Adjuvanted placebo on Day 0, saline (0.5mL) on Day 21 Saline: Subcutaneous injection in the upper arm with 0.5ml of saline Adjuvanted placebo: Subcutaneous injection in the upper arm with an emulsion made with 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection
Surgical and medical procedures Abdominal hernia repair	1.7% 1/58 • Number of events 1 • From vaccination to study completion (approx. 7 months) Solicited Adverse Events were collected for 21 days after each vaccination. Subjects had to fill in the AEs diary card daily and return to the clinic on the next scheduled visit. Unsolicited Adverse Events and Severe Adverse Events were collected at any time during the study directly to the PI or study doctor.	0.00% 0/57 • From vaccination to study completion (approx. 7 months) Solicited Adverse Events were collected for 21 days after each vaccination. Subjects had to fill in the AEs diary card daily and return to the clinic on the next scheduled visit. Unsolicited Adverse Events and Severe Adverse Events were collected at any time during the study directly to the PI or study doctor.	0.00% 0/32 • From vaccination to study completion (approx. 7 months) Solicited Adverse Events were collected for 21 days after each vaccination. Subjects had to fill in the AEs diary card daily and return to the clinic on the next scheduled visit. Unsolicited Adverse Events and Severe Adverse Events were collected at any time during the study directly to the PI or study doctor.	0.00% 0/27 • From vaccination to study completion (approx. 7 months) Solicited Adverse Events were collected for 21 days after each vaccination. Subjects had to fill in the AEs diary card daily and return to the clinic on the next scheduled visit. Unsolicited Adverse Events and Severe Adverse Events were collected at any time during the study directly to the PI or study doctor.
Cardiac disorders Myocardial Infarction	1.7% 1/58 • Number of events 1 • From vaccination to study completion (approx. 7 months) Solicited Adverse Events were collected for 21 days after each vaccination. Subjects had to fill in the AEs diary card daily and return to the clinic on the next scheduled visit. Unsolicited Adverse Events and Severe Adverse Events were collected at any time during the study directly to the PI or study doctor.	0.00% 0/57 • From vaccination to study completion (approx. 7 months) Solicited Adverse Events were collected for 21 days after each vaccination. Subjects had to fill in the AEs diary card daily and return to the clinic on the next scheduled visit. Unsolicited Adverse Events and Severe Adverse Events were collected at any time during the study directly to the PI or study doctor.	0.00% 0/32 • From vaccination to study completion (approx. 7 months) Solicited Adverse Events were collected for 21 days after each vaccination. Subjects had to fill in the AEs diary card daily and return to the clinic on the next scheduled visit. Unsolicited Adverse Events and Severe Adverse Events were collected at any time during the study directly to the PI or study doctor.	0.00% 0/27 • From vaccination to study completion (approx. 7 months) Solicited Adverse Events were collected for 21 days after each vaccination. Subjects had to fill in the AEs diary card daily and return to the clinic on the next scheduled visit. Unsolicited Adverse Events and Severe Adverse Events were collected at any time during the study directly to the PI or study doctor.
Injury, poisoning and procedural complications upper limb fracture	0.00% 0/58 • From vaccination to study completion (approx. 7 months) Solicited Adverse Events were collected for 21 days after each vaccination. Subjects had to fill in the AEs diary card daily and return to the clinic on the next scheduled visit. Unsolicited Adverse Events and Severe Adverse Events were collected at any time during the study directly to the PI or study doctor.	1.8% 1/57 • Number of events 1 • From vaccination to study completion (approx. 7 months) Solicited Adverse Events were collected for 21 days after each vaccination. Subjects had to fill in the AEs diary card daily and return to the clinic on the next scheduled visit. Unsolicited Adverse Events and Severe Adverse Events were collected at any time during the study directly to the PI or study doctor.	0.00% 0/32 • From vaccination to study completion (approx. 7 months) Solicited Adverse Events were collected for 21 days after each vaccination. Subjects had to fill in the AEs diary card daily and return to the clinic on the next scheduled visit. Unsolicited Adverse Events and Severe Adverse Events were collected at any time during the study directly to the PI or study doctor.	0.00% 0/27 • From vaccination to study completion (approx. 7 months) Solicited Adverse Events were collected for 21 days after each vaccination. Subjects had to fill in the AEs diary card daily and return to the clinic on the next scheduled visit. Unsolicited Adverse Events and Severe Adverse Events were collected at any time during the study directly to the PI or study doctor.
Psychiatric disorders Depression	0.00% 0/58 • From vaccination to study completion (approx. 7 months) Solicited Adverse Events were collected for 21 days after each vaccination. Subjects had to fill in the AEs diary card daily and return to the clinic on the next scheduled visit. Unsolicited Adverse Events and Severe Adverse Events were collected at any time during the study directly to the PI or study doctor.	1.8% 1/57 • Number of events 1 • From vaccination to study completion (approx. 7 months) Solicited Adverse Events were collected for 21 days after each vaccination. Subjects had to fill in the AEs diary card daily and return to the clinic on the next scheduled visit. Unsolicited Adverse Events and Severe Adverse Events were collected at any time during the study directly to the PI or study doctor.	0.00% 0/32 • From vaccination to study completion (approx. 7 months) Solicited Adverse Events were collected for 21 days after each vaccination. Subjects had to fill in the AEs diary card daily and return to the clinic on the next scheduled visit. Unsolicited Adverse Events and Severe Adverse Events were collected at any time during the study directly to the PI or study doctor.	0.00% 0/27 • From vaccination to study completion (approx. 7 months) Solicited Adverse Events were collected for 21 days after each vaccination. Subjects had to fill in the AEs diary card daily and return to the clinic on the next scheduled visit. Unsolicited Adverse Events and Severe Adverse Events were collected at any time during the study directly to the PI or study doctor.
Psychiatric disorders Alcohol problem	0.00% 0/58 • From vaccination to study completion (approx. 7 months) Solicited Adverse Events were collected for 21 days after each vaccination. Subjects had to fill in the AEs diary card daily and return to the clinic on the next scheduled visit. Unsolicited Adverse Events and Severe Adverse Events were collected at any time during the study directly to the PI or study doctor.	1.8% 1/57 • Number of events 1 • From vaccination to study completion (approx. 7 months) Solicited Adverse Events were collected for 21 days after each vaccination. Subjects had to fill in the AEs diary card daily and return to the clinic on the next scheduled visit. Unsolicited Adverse Events and Severe Adverse Events were collected at any time during the study directly to the PI or study doctor.	0.00% 0/32 • From vaccination to study completion (approx. 7 months) Solicited Adverse Events were collected for 21 days after each vaccination. Subjects had to fill in the AEs diary card daily and return to the clinic on the next scheduled visit. Unsolicited Adverse Events and Severe Adverse Events were collected at any time during the study directly to the PI or study doctor.	0.00% 0/27 • From vaccination to study completion (approx. 7 months) Solicited Adverse Events were collected for 21 days after each vaccination. Subjects had to fill in the AEs diary card daily and return to the clinic on the next scheduled visit. Unsolicited Adverse Events and Severe Adverse Events were collected at any time during the study directly to the PI or study doctor.

Other adverse events

Additional Information

Dr Olga Pleguezuelos, Chief Scientific Officer

PepTcell Ltd (trading as SEEK)

Phone: +44 020 7153 6601

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place