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Clinical Trial Results:
A Phase I/II, randomized, controlled, observer-blind, multi-center study to assess the reactogenicity, safety and immunogenicity of three GlaxoSmithKline (GSK) Biologicals’ investigational supra-seasonal universal influenza vaccines (SUIVs) (unadjuvanted or adjuvanted with AS03 or AS01) administered as a 1 or 2-dose priming schedule followed by a booster dose 12 months post-primary vaccination in 18 to 39 year-old healthy subjects

Summary
EudraCT number	2017-001584-20
Trial protocol	BE
Global end of trial date	26 Mar 2020

Results information
Results version number	v2(current)
This version publication date	01 May 2021
First version publication date	01 Apr 2021
Other versions	v1
Version creation reason	Correction of full data set Results have been amended to account for consistency with other registries.

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

207543

ISRCTN number

US NCT number

NCT03275389

WHO universal trial number (UTN)

Sponsor organisation name

GlaxoSmithKline Biologicals

Sponsor organisation address

Rue de l’Institut 89, Rixensart, Belgium, B-1330

Public contact

Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com

Scientific contact

Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

10 Dec 2020

Is this the analysis of the primary completion data?

Yes

Primary completion date

26 Mar 2020

Global end of trial reached?

Yes

Global end of trial date

26 Mar 2020

Was the trial ended prematurely?

Main objective of the trial

To assess the reactogenicity and safety of each vaccine dose throughout the entire study period, in all study groups. To describe the anti-H1 stalk humoral immune response 28 days after each priming dose (1 or 2 dose(s)) in all study groups.

Protection of trial subjects

The subjects were observed closely for at least 60 minutes (Phase I subjects) or 30 minutes (Phase II subjects) following the administration of the vaccines/products, with appropriate medical treatment readily available in case of anaphylaxis.

Background therapy

Evidence for comparator

Actual start date of recruitment

08 Sep 2017

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Belgium: 101

Country: Number of subjects enrolled

United States: 369

Worldwide total number of subjects

470

EEA total number of subjects

101

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

470

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

470 subjects were enrolled and randomized in the study, however, while 2 subjects were allocated subjects numbers, they did not receive any vaccine dose.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Assessor

Blinding implementation details

The site staff worked in an observer-blind manner. As the vaccines appearance and preparation were different, two teams of study personnel were set up: • A team of unblinded personnel (responsible for the reception, preparation and administration of the vaccines). • A team of blinded personnel (responsible for the clinical safety evaluation of the subjects).

Are arms mutually exclusive

Yes

D-SUIV Adjuvanted Group 1

Arm description

Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.

Arm type

Experimental

Investigational medicinal product name

D-SUIV cH8/1N1+AS03 Placebo D-SUIV cH5/1N1+AS03

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solvent for emulsion for injection

Routes of administration

Intramuscular use

Dosage and administration details

1 dose at Day 1 (D-SUIV cH8/1N1+AS03) 1 dose at Day 57 (Placebo); 1 dose at Month 14 (D-SUIV cH5/1N1+AS03)

D-SUIV Adjuvanted Group 2

Arm description

Subjects received one dose of D-SUIV cH5/1N1+AS03 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.

Arm type

Experimental

Investigational medicinal product name

D-SUIV cH5/1N1+AS03 Placebo D-SUIV cH8/1N1+AS03

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solvent for emulsion for injection

Routes of administration

Intramuscular use

Dosage and administration details

1 dose at Day 1 (D-SUIV cH5/1N1+AS03); 1 dose at Day 57 (Placebo); 1 dose at Month 14 (D-SUIV cH8/1N1+AS03)

D-SUIV Adjuvanted Group 3

Arm description

Subjects received one dose of D-SUIV cH8/1N1+AS03 vaccine at Day 1, one dose D-SUIV cH5/1N1+AS03 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS03 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.

Arm type

Experimental

Investigational medicinal product name

D-SUIV cH8/1N1+AS03 D-SUIV cH5/1N1+AS03 D-SUIV cH11/1N1+AS03

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solvent for emulsion for injection

Routes of administration

Intramuscular use

Dosage and administration details

1 dose at Day 1 (D-SUIV cH8/1N1+AS03); 1 dose at Day 57 (D-SUIV cH5/1N1+AS03); 1 dose at Month 14 (D-SUIV cH11/1N1+AS03)

D-SUIV Adjuvanted Group 4

Arm description

Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.

Arm type

Experimental

Investigational medicinal product name

D-SUIV cH8/1N1+AS01 Placebo D-SUIV cH5/1N1+AS01

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solvent for emulsion for injection

Routes of administration

Intramuscular use

Dosage and administration details

1 dose at Day 1 (D-SUIV cH8/1N1+AS01); 1 dose at Day 57 (Placebo); 1 dose at Month 14 (D-SUIV cH5/1N1+AS01)

D-SUIV Adjuvanted Group 5

Arm description

Subjects received one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.

Arm type

Experimental

Investigational medicinal product name

D-SUIV cH5/1N1+AS01 Placebo D-SUIV cH8/1N1+AS01

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solvent for suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

1 dose at Day 1 (D-SUIV cH5/1N1+AS01); 1 dose at Day 57 (Placebo); 1 dose at Month 14 (D-SUIV cH8/1N1+AS01)

D-SUIV Adjuvanted Group 6

Arm description

Subjects received one dose of D-SUIV cH8/1N1+AS01 vaccine at Day 1, one dose of D-SUIV cH5/1N1+AS01 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1+AS01 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.

Arm type

Experimental

Investigational medicinal product name

D-SUIV cH8/1N1+AS01 D-SUIV cH5/1N1+AS01 D-SUIV cH11/1N1+AS01

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solvent for suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

1 dose at Day 1 (D-SUIV cH8/1N1+AS01); 1 dose at Day 57 (D-SUIV cH5/1N1+AS01); 1 dose at Month 14 (D-SUIV cH11/1N1+AS01)

D-SUIV Unadjuvanted Group 1

Arm description

Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH5/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.

Arm type

Experimental

Investigational medicinal product name

D-SUIV cH8/1N1 Placebo D-SUIV cH5/1N1

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solvent for suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

1 dose at Day 1 (D-SUIV cH8/1N1); 1 dose at Day 57 (Placebo); 1 dose at Month 14 (D-SUIV cH5/1N1)

D-SUIV Unadjuvanted Group 2

Arm description

Subjects received one dose of D-SUIV cH5/1N1 vaccine at Day 1, one dose of Placebo at Day 57 and one booster dose of D-SUIV cH8/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.

Arm type

Experimental

Investigational medicinal product name

D-SUIV cH5/1N1 Placebo D-SUIV cH8/1N1

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solvent for suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

1 dose at Day 1 (D-SUIV cH5/1N1); 1 dose at Day 57 (Placebo); 1 dose at Month 14 (D-SUIV cH8/1N1)

D-SUIV Unadjuvanted Group 3

Arm description

Subjects received one dose of D-SUIV cH8/1N1 vaccine at Day 1, one dose of D-SUIV cH5/1N1 vaccine at Day 57 and one booster dose of D-SUIV cH11/1N1 vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.

Arm type

Experimental

Investigational medicinal product name

D-SUIV cH8/1N1 D-SUIV cH5/1N1 D-SUIV cH11/1N1

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder and solvent for suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

1 dose at Day 1 (D-SUIV cH8/1N1); 1 dose at Day 57 (D-SUIV cH5/1N1); 1 dose at Month 14 (D-SUIV cH11/1N1)

IIV4 Group

Arm description

Subjects received one dose of Fluarix Quadrivalent (IIV4) vaccine at Day 1, one dose of Placebo at Day 57 and one dose of Fluarix Quadrivalent vaccine at Month 14. All doses were administered intramuscularly in the non-dominant arm.

Arm type

Active comparator

Investigational medicinal product name

Fluarix Quadrivalent (IIV4); Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Suspension for injection in pre-filled syringe

Routes of administration

Intramuscular use

Dosage and administration details

1 dose at Day 1 (Fluarix Quadrivalent (IIV4)) 1 dose at Day 57 (Placebo) 1 dose at Month 14 (Fluarix Quadrivalent)

Number of subjects in period 1 ^[1]	D-SUIV Adjuvanted Group 1	D-SUIV Adjuvanted Group 2	D-SUIV Adjuvanted Group 3	D-SUIV Adjuvanted Group 4	D-SUIV Adjuvanted Group 5	D-SUIV Adjuvanted Group 6	D-SUIV Unadjuvanted Group 1	D-SUIV Unadjuvanted Group 2	D-SUIV Unadjuvanted Group 3	IIV4 Group
Started	45	46	47	47	48	47	47	48	46	47
Completed	34	30	24	25	32	29	22	30	31	29
Not completed	11	16	23	22	16	18	25	18	15	18
NOT WILLING TO PARTICIPATE THIS VISIT	-	-	1	-	-	-	-	-	-	1
Unknown	-	4	3	2	2	2	-	-	1	-
MIGRATED / MOVED FROM THE STUDY AREA	-	2	-	3	-	-	1	-	-	-
Lost to follow-up	10	10	19	12	11	12	21	15	12	14
SERIOUS ADVERSE EVENT AND/OR PIMD	-	-	-	-	-	1	-	-	-	1
CONSENT WITHDRAWAL NOT DUE TO ADV. EVENT	1	-	-	5	3	3	3	3	2	2

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: 470 subjects were enrolled and randomized in the study, however, while 2 subjects were allocated subjects numbers, they did not receive any vaccine dose.

Baseline characteristics

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Reporting group title

D-SUIV Adjuvanted Group 1

Reporting group description

Reporting group title

D-SUIV Adjuvanted Group 2

Reporting group description

Reporting group title

D-SUIV Adjuvanted Group 3

Reporting group description

Reporting group title

D-SUIV Adjuvanted Group 4

Reporting group description

Reporting group title

D-SUIV Adjuvanted Group 5

Reporting group description

Reporting group title

D-SUIV Adjuvanted Group 6

Reporting group description

Reporting group title

D-SUIV Unadjuvanted Group 1

Reporting group description

Reporting group title

D-SUIV Unadjuvanted Group 2

Reporting group description

Reporting group title

D-SUIV Unadjuvanted Group 3

Reporting group description

Reporting group title

IIV4 Group

Reporting group description

Reporting group values	D-SUIV Adjuvanted Group 1	D-SUIV Adjuvanted Group 2	D-SUIV Adjuvanted Group 3	D-SUIV Adjuvanted Group 4	D-SUIV Adjuvanted Group 5	D-SUIV Adjuvanted Group 6	D-SUIV Unadjuvanted Group 1	D-SUIV Unadjuvanted Group 2	D-SUIV Unadjuvanted Group 3	IIV4 Group	Total
Number of subjects	45	46	47	47	48	47	47	48	46	47	468
Age categorical
Units: Subjects
In utero	0	0	0	0	0	0	0	0	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0	0	0	0	0	0	0	0	0
Newborns (0-27 days)	0	0	0	0	0	0	0	0	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0	0	0	0	0	0	0	0	0
Children (2-11 years)	0	0	0	0	0	0	0	0	0	0	0
Adolescents (12-17 years)	0	0	0	0	0	0	0	0	0	0	0
Adults (18-64 years)	45	46	47	47	48	47	47	48	46	47	468
From 65-84 years	0	0	0	0	0	0	0	0	0	0	0
85 years and over	0	0	0	0	0	0	0	0	0	0	0
Age continuous
Units: years
arithmetic mean (standard deviation)	29.0 ± 6.6	29.3 ± 5.7	28.6 ± 6.0	28.7 ± 6.4	29.1 ± 6.2	28.8 ± 6.1	29.6 ± 5.8	28.5 ± 5.9	28.8 ± 5.9	29.3 ± 5.8	-
Sex: Female, Male
Units: Participants
Female	26	27	28	28	27	27	27	26	25	27	268
Male	19	19	19	19	21	20	20	22	21	20	200
Race/Ethnicity, Customized
Units: Subjects
American indian or alaska native	0	0	0	0	1	0	0	0	0	0	1
Asian - central / south asian heritage	0	0	0	0	0	0	0	0	1	0	1
Asian - east asian heritage	0	1	0	0	0	0	0	0	0	0	1
Asian - south east asian heritage	0	1	0	1	0	0	0	0	0	0	2
Black or african american	11	9	10	8	5	7	10	13	6	9	88
Native hawaiian or other pacific islander	0	0	0	0	0	0	1	0	0	0	1
Other, Not specified	0	0	0	2	2	1	1	1	2	1	10
White - arabic / north african heritage	0	1	0	0	0	1	0	1	0	2	5
White - caucasian / european heritage	34	34	37	36	40	38	35	33	37	35	359

End points

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Reporting group title

D-SUIV Adjuvanted Group 1

Reporting group description

Reporting group title

D-SUIV Adjuvanted Group 2

Reporting group description

Reporting group title

D-SUIV Adjuvanted Group 3

Reporting group description

Reporting group title

D-SUIV Adjuvanted Group 4

Reporting group description

Reporting group title

D-SUIV Adjuvanted Group 5

Reporting group description

Reporting group title

D-SUIV Adjuvanted Group 6

Reporting group description

Reporting group title

D-SUIV Unadjuvanted Group 1

Reporting group description

Reporting group title

D-SUIV Unadjuvanted Group 2

Reporting group description

Reporting group title

D-SUIV Unadjuvanted Group 3

Reporting group description

Reporting group title

IIV4 Group

Reporting group description

Primary: Number of subjects with solicited local adverse events (AEs) after first dose administration

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End point title

Number of subjects with solicited local adverse events (AEs) after first dose administration ^[1]

End point description

Assessed solicited local symptoms are pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Any erythema/swelling = erythema/swelling spreading beyond 20 millimeters (mm) of injection site.

End point type

Primary

End point timeframe

During the 7-day (Days 1-7) follow-up period after first vaccine dose

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This outcome was descriptive; hence no statistical analyses were required.

End point values	D-SUIV Adjuvanted Group 1	D-SUIV Adjuvanted Group 2	D-SUIV Adjuvanted Group 3	D-SUIV Adjuvanted Group 4	D-SUIV Adjuvanted Group 5	D-SUIV Adjuvanted Group 6	D-SUIV Unadjuvanted Group 1	D-SUIV Unadjuvanted Group 2	D-SUIV Unadjuvanted Group 3	IIV4 Group
Number of subjects analysed	44	46	45	46	46	46	45	47	46	45
Units: Participants
Erythema	1	3	2	2	1	3	1	0	1	0
Pain	34	42	37	39	40	42	16	13	15	35
Swelling	4	2	2	4	3	2	0	0	1	0

No statistical analyses for this end point

Primary: Number of subjects with solicited local AEs after second dose administration

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End point title

Number of subjects with solicited local AEs after second dose administration ^[2]

End point description

End point type

Primary

End point timeframe

During the 7-day (Days 1-7) follow-up period after second vaccine dose

Notes
[2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This outcome was descriptive; hence no statistical analyses were required.

End point values	D-SUIV Adjuvanted Group 1	D-SUIV Adjuvanted Group 2	D-SUIV Adjuvanted Group 3	D-SUIV Adjuvanted Group 4	D-SUIV Adjuvanted Group 5	D-SUIV Adjuvanted Group 6	D-SUIV Unadjuvanted Group 1	D-SUIV Unadjuvanted Group 2	D-SUIV Unadjuvanted Group 3	IIV4 Group
Number of subjects analysed	40	37	36	41	41	37	38	39	40	39
Units: Participants
Erythema	0	0	1	0	0	0	0	0	0	0
Pain	5	2	29	2	8	32	4	5	12	10
Swelling	0	0	4	0	0	2	0	0	0	0

No statistical analyses for this end point

Primary: Number of subjects with solicited local AEs after booster dose administration

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End point title

Number of subjects with solicited local AEs after booster dose administration ^[3]

End point description

End point type

Primary

End point timeframe

During the 7-day (Days 1-7) follow-up period after booster vaccine dose

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This outcome was descriptive; hence no statistical analyses were required.

End point values	D-SUIV Adjuvanted Group 1	D-SUIV Adjuvanted Group 2	D-SUIV Adjuvanted Group 3	D-SUIV Adjuvanted Group 4	D-SUIV Adjuvanted Group 5	D-SUIV Adjuvanted Group 6	D-SUIV Unadjuvanted Group 1	D-SUIV Unadjuvanted Group 2	D-SUIV Unadjuvanted Group 3	IIV4 Group
Number of subjects analysed	33	32	27	30	31	30	24	32	33	31
Units: Participants
Erythema	1	1	0	0	1	1	0	0	0	0
Pain	27	31	26	29	28	25	4	10	13	21
Swelling	2	2	0	1	1	1	0	0	0	0

No statistical analyses for this end point

Primary: Number of subjects with solicited general AEs after first dose administration

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End point title

Number of subjects with solicited general AEs after first dose administration ^[4]

End point description

Assessed solicited general symptoms are arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering and fever [defined as oral temperature equal to or above 38.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade

End point type

Primary

End point timeframe

During the 7-day (Days 1-7) follow-up period after first vaccine dose

Notes
[4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This outcome was descriptive; hence no statistical analyses were required.

End point values	D-SUIV Adjuvanted Group 1	D-SUIV Adjuvanted Group 2	D-SUIV Adjuvanted Group 3	D-SUIV Adjuvanted Group 4	D-SUIV Adjuvanted Group 5	D-SUIV Adjuvanted Group 6	D-SUIV Unadjuvanted Group 1	D-SUIV Unadjuvanted Group 2	D-SUIV Unadjuvanted Group 3	IIV4 Group
Number of subjects analysed	44	46	45	46	46	46	45	47	46	46
Units: Participants
Arthralgia	4	6	9	2	3	8	6	5	2	5
Fatigue	17	18	22	18	21	18	17	19	12	12
Gastrointestinal symptoms	6	7	10	6	8	8	6	8	10	8
Headache	18	18	19	23	16	26	16	19	15	14
Myalgia	16	13	19	17	19	20	9	9	6	11
Shivering	6	3	10	10	8	9	2	2	2	3
Temperature	1	1	0	2	2	1	1	1	0	0

No statistical analyses for this end point

Primary: Number of subjects with solicited general AEs after second dose administration

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End point title

Number of subjects with solicited general AEs after second dose administration ^[5]

End point description

End point type

Primary

End point timeframe

During the 7-day (Days 1-7) follow-up period after second vaccine dose

Notes
[5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This outcome was descriptive; hence no statistical analyses were required.

End point values	D-SUIV Adjuvanted Group 1	D-SUIV Adjuvanted Group 2	D-SUIV Adjuvanted Group 3	D-SUIV Adjuvanted Group 4	D-SUIV Adjuvanted Group 5	D-SUIV Adjuvanted Group 6	D-SUIV Unadjuvanted Group 1	D-SUIV Unadjuvanted Group 2	D-SUIV Unadjuvanted Group 3	IIV4 Group
Number of subjects analysed	40	37	36	41	41	39	38	39	40	40
Units: Participants
Arthralgia	3	4	4	0	4	4	0	0	2	2
Fatigue	7	7	10	6	7	8	5	5	10	5
Gastrointestinal symptoms	3	4	4	3	3	6	1	4	2	2
Headache	8	12	13	7	9	12	5	12	8	7
Myalgia	5	6	12	1	4	16	3	2	6	3
Shivering	2	4	4	0	3	5	1	0	2	1
Temperature	1	2	0	0	1	2	0	0	0	0

No statistical analyses for this end point

Primary: Number of subjects with solicited general AEs after booster dose administration

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End point title

Number of subjects with solicited general AEs after booster dose administration ^[6]

End point description

End point type

Primary

End point timeframe

During the 7-day (Days 1-7) follow-up period after booster vaccine dose

Notes
[6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This outcome was descriptive; hence no statistical analyses were required.

End point values	D-SUIV Adjuvanted Group 1	D-SUIV Adjuvanted Group 2	D-SUIV Adjuvanted Group 3	D-SUIV Adjuvanted Group 4	D-SUIV Adjuvanted Group 5	D-SUIV Adjuvanted Group 6	D-SUIV Unadjuvanted Group 1	D-SUIV Unadjuvanted Group 2	D-SUIV Unadjuvanted Group 3	IIV4 Group
Number of subjects analysed	33	32	27	30	31	30	24	32	33	31
Units: Participants
Arthralgia	6	8	4	4	9	4	1	1	2	1
Fatigue	15	19	17	16	20	9	2	6	6	3
Gastrointestinal symptoms	3	8	8	5	6	5	1	2	4	0
Headache	9	13	14	15	16	15	3	7	6	4
Myalgia	15	17	15	15	13	10	0	4	5	3
Shivering	5	13	6	6	14	9	0	1	2	1
Temperature	2	3	1	4	2	1	0	0	0	0

No statistical analyses for this end point

Primary: Number of subjects with any unsolicited AEs post-vaccination period

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End point title

Number of subjects with any unsolicited AEs post-vaccination period ^[7]

End point description

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination

End point type

Primary

End point timeframe

During the 28-day (Days 1-28) follow-up period accross doses

Notes
[7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This outcome was descriptive; hence no statistical analyses were required.

End point values	D-SUIV Adjuvanted Group 1	D-SUIV Adjuvanted Group 2	D-SUIV Adjuvanted Group 3	D-SUIV Adjuvanted Group 4	D-SUIV Adjuvanted Group 5	D-SUIV Adjuvanted Group 6	D-SUIV Unadjuvanted Group 1	D-SUIV Unadjuvanted Group 2	D-SUIV Unadjuvanted Group 3	IIV4 Group
Number of subjects analysed	45	46	47	47	48	47	47	48	46	47
Units: Participants	27	23	23	24	24	17	22	23	22	21

No statistical analyses for this end point

Primary: Number of subjects with change from baseline in hematological and biochemical laboratory results at Day 8 by toxicity grading

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End point title

Number of subjects with change from baseline in hematological and biochemical laboratory results at Day 8 by toxicity grading ^[8]

End point description

Hematological parameters assessed are: Eosinophils increase [EOSi], hemoglobin decrease [HEMd] , lymphocytes decrease [LYMd], Neutrophils decrease [NEUd], platelets decrease [PLTCd], white blood cells decrease [WBCd], WBC increase [WBCi]. Biochemical parameters assessed are: alanine aminotransferase increase [ALTi], aspartate aminotransferase increase [ASTi], blood urea nitrogen [BUN], creatinine [CRE].Toxicity grading is according to the Food and Drug Administration (FDA) guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical Trials (September 2007). The grading scale is defined as follows: mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4). Category naming has been defined as follows: Parameter- grading at Baseline- grading at Timing: e.g.: "ALTi-G0-G1" (with G=Grade and UNK= Unknown).

End point type

Primary

End point timeframe

At Day 8

Notes
[8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This outcome was descriptive; hence no statistical analyses were required.

End point values	D-SUIV Adjuvanted Group 1	D-SUIV Adjuvanted Group 2	D-SUIV Adjuvanted Group 3	D-SUIV Adjuvanted Group 4	D-SUIV Adjuvanted Group 5	D-SUIV Adjuvanted Group 6	D-SUIV Unadjuvanted Group 1	D-SUIV Unadjuvanted Group 2	D-SUIV Unadjuvanted Group 3	IIV4 Group
Number of subjects analysed	44	46	45	46	46	46	44	47	45	46
Units: Participants
ALTi, UNK, G0 (N=0;0;0;0;0;0;1;0;1;0)	0	0	0	0	0	0	0	0	1	0
ALTi, UNK, G1 (N=0;0;0;0;0;0;1;0;1;0)	0	0	0	0	0	0	1	0	0	0
ALTi,G0,UNK (N=40;46;43;45;45;45;44;44;43;46)	0	0	0	3	0	0	1	0	0	1
ALTi, G0, G0 (N=40;46;43;45;45;45;44;44;43;46)	40	45	42	41	45	45	43	44	41	44
ALTi, G0, G1 (N=40;46;43;45;45;45;44;44;43;46)	0	1	1	0	0	0	0	0	2	1
ALTi, G0, G3 (N=40;46;43;45;45;45;44;44;43;46)	0	0	0	1	0	0	0	0	0	0
ALTi, G1, G0 (N=4;0;2;1;1;1;0;3;2;0)	3	0	1	1	1	0	0	2	2	0
ALTi, G1, G1 (N=4;0;2;1;1;1;0;3;2;0)	1	0	1	0	0	1	0	1	0	0
ASTi, UNK, G0 (N=0;0;0;0;0;0;1;0;1;0)	0	0	0	0	0	0	1	0	1	0
ASTi, G0, UNK (N=44;46;45;46;46;45;43;46;45;46)	0	0	0	3	0	0	1	0	0	1
ASTi, G0, G0 (N=44;46;45;46;46;45;43;46;45;46)	44	46	44	42	46	45	42	44	44	44
ASTi, G0, G1 (N=44;46;45;46;46;45;43;46;45;46)	0	0	1	0	0	0	0	2	0	0
ASTi, G0, G2 (N=44;46;45;46;46;45;43;46;45;46)	0	0	0	0	0	0	0	0	1	1
ASTi, G0, G4 (N=44;46;45;46;46;45;43;46;45;46)	0	0	0	1	0	0	0	0	0	0
ASTi, G1, G0 (N=0;0;0;0;0;1;1;0;0;0)	0	0	0	0	0	1	1	0	0	0
ASTi, G2, G0 (N=0;0;0;0;0;0;0;1;0;0)	0	0	0	0	0	0	0	1	0	0
BUN, UNK, G0 (N=0;0;0;0;0;0;1;0;1;0)	0	0	0	0	0	0	1	0	1	0
BUN, G0, UNK (N=43;46;45;46;46;46;44;47;43;46)	0	0	0	3	0	0	1	0	0	1
BUN, G0, G0 (N=43;46;45;46;46;46;44;47;43;46)	43	46	45	43	46	46	43	47	43	45
BUN, G1, G0 (N=1;0;0;0;0;0;0;0;1;0)	1	0	0	0	0	0	0	0	1	0
BUN, G2, G0 (N=0;0;0;0;0;0;0;0;1;0)	0	0	0	0	0	0	0	0	1	0
CRE, UNK, G0 (N=0;0;0;0;0;0;1;0;1;0)	0	0	0	0	0	0	1	0	1	0
CRE, G0, UNK (N=44;46;45;46;46;46;44;47;45;46)	0	0	0	3	0	0	1	0	0	1
CRE, G0, G0 (N=44;46;45;46;46;46;44;47;45;46)	44	46	45	43	46	46	43	47	45	45
EOSi, UNK, G0 (N=1;1;3;1;1;1;1;2;5;2)	1	1	3	1	1	1	1	2	5	2
EOSi, G0, UNK (N=43;44;41;44;45;45;44;45;40;43)	2	0	2	1	0	0	2	2	1	2
EOSi, G0, G0 (N=43;44;41;44;45;45;44;45;40;43)	41	43	38	43	45	44	40	43	38	41
EOSi, G0, G1 (N=43;44;41;44;45;45;44;45;40;43)	0	1	1	0	0	1	2	0	1	0
EOSi, G1, G0 (N=0;1;1;1;0;0;0;0;1;1)	0	1	1	1	0	0	0	0	0	0
EOSi, G1, G1 (N=0;1;1;1;0;0;0;0;1;1)	0	0	0	0	0	0	0	0	1	1
HEMd, UNK, G0 (N=0;1;0;0;0;0;1;0;0;1)	0	1	0	0	0	0	1	0	0	1
HEMd, G0, UNK (N=39;41;42;42;44;43;39;42;43;43)	1	0	1	1	0	0	1	1	1	2
HEMd, G0, G0 (N=39;41;42;42;44;43;39;42;43;43)	37	37	40	39	43	40	37	40	40	40
HEMd, G0, G1 (N=39;41;42;42;44;43;39;42;43;43)	1	4	1	1	1	3	1	1	2	1
HEMd, G0, G2 (N=39;41;42;42;44;43;39;42;43;43)	0	0	0	1	0	0	0	0	0	0
HEMd, G1, UNK (N=3;3;2;4;0;2;4;2;1;2)	0	0	0	0	0	0	1	0	0	0
HEMd, G1, G0 (N=3;3;2;4;0;2;4;2;1;2)	0	0	0	0	0	0	1	2	0	1
HEMd, G1, G1 (N=3;3;2;4;0;2;4;2;1;2)	3	1	2	4	0	1	2	0	0	0
HEMd, G1, G2 (N=3;3;2;4;0;2;4;2;1;2)	0	2	0	0	0	1	0	0	1	1
HEMd, G2, G1 (N=2;0;1;0;2;1;1;2;2;0)	0	0	0	0	0	0	1	0	0	0
HEMd, G2, G2 (N=2;0;1;0;2;1;1;2;2;0)	2	0	1	0	2	1	0	0	2	0
HEMd, G2, G3 (N=2;0;1;0;2;1;1;2;2;0)	0	0	0	0	0	0	0	2	0	0
HEMd, G3, UNK (N=0;1;0;0;0;0;0;1;0;0)	0	0	0	0	0	0	0	1	0	0
HEMd, G3, G3 (N=0;1;0;0;0;0;0;1;0;0)	0	1	0	0	0	0	0	0	0	0
LYMd, UNK, G0 (N=1;1;3;1;1;1;1;2;5;2)	1	1	3	1	1	1	1	2	5	2
LYMd, G0, UNK (N=43;45;39;45;44;45;44;45;39;44)	2	0	2	1	0	0	2	2	1	2
LYMd, G0, G0 (N=43;45;39;45;44;45;44;45;39;44)	39	45	37	44	43	45	42	42	38	41
LYMd, G0, G1 (N=43;45;39;45;44;45;44;45;39;44)	2	0	0	0	1	0	0	1	0	1
LYMd, G1, G0 (N=0;0;3;0;0;0;0;0;2;0)	0	0	2	0	0	0	0	0	2	0
LYMd, G1, G2 (N=0;0;3;0;0;0;0;0;2;0)	0	0	1	0	0	0	0	0	0	0
LYMd, G2, G0 (N=0;0;0;0;1;0;0;0;0;0)	0	0	0	0	1	0	0	0	0	0
NEUd, UNK, G0 (N=1;1;3;1;1;1;1;2;5;2)	1	1	3	1	1	1	1	2	2	1
NEUd, UNK, G1 (N=1;1;3;1;1;1;1;2;5;2)	0	0	0	0	0	0	0	0	2	1
NEUd, UNK, G2 (N=1;1;3;1;1;1;1;2;5;2)	0	0	0	0	0	0	0	0	1	0
NEUd, G0, UNK (N=41;41;41;44;41;44;43;41;39;41)	2	0	2	1	0	0	2	2	1	2
NEUd, G0, G0 (N=41;41;41;44;41;44;43;41;39;41)	37	40	39	41	41	43	39	38	37	37
NEUd, G0, G1 (N=41;41;41;44;41;44;43;41;39;41)	2	1	0	1	0	0	1	1	0	2
NEUd, G0, G2 (N=41;41;41;44;41;44;43;41;39;41)	0	0	0	1	0	1	1	0	1	0
NEUd, G1, G0 (N=2;4;0;1;2;1;1;2;1;1)	1	4	0	0	0	1	0	0	1	1
NEUd, G1, G1 (N=2;4;0;1;2;1;1;2;1;1)	1	0	0	0	2	0	1	2	0	0
NEUd, G1, G2 (N=2;4;0;1;2;1;1;2;1;1)	0	0	0	1	0	0	0	0	0	0
NEUd, G2, G0 (N=0;0;1;0;1;0;0;2;1;2)	0	0	1	0	1	0	0	2	1	2
NEUd, G3, G0 (N=0;0;0;0;1;0;0;0;0;0)	0	0	0	0	1	0	0	0	0	0
PLTCd, UNK, G0 (N=0;1;0;0;0;0;1;0;1;1)	0	1	0	0	0	0	1	0	1	1
PLTCd, G0, UNK (N=44;45;45;44;46;46;44;46;44;45)	1	0	2	1	0	0	2	2	1	2
PLTCd, G0, G0 (N=44;45;45;44;46;46;44;46;44;45)	43	45	42	43	46	45	42	44	43	43
PLTCd, G0, G1 (N=44;45;45;44;46;46;44;46;44;45)	0	0	0	0	0	1	0	0	0	0
PLTCd, G0, G2 (N=44;45;45;44;46;46;44;46;44;45)	0	0	1	0	0	0	0	0	0	0
PLTCd, G1, G0 (N=0;0;0;2;0;0;0;1;0;0)	0	0	0	1	0	0	0	1	0	0
PLTCd, G1, G1 (N=0;0;0;2;0;0;0;1;0;0)	0	0	0	1	0	0	0	0	0	0
PLTCd, G2, G1 (N=0;0;0;0;0;0;0;0;1;0)	0	0	0	0	0	0	0	0	1	0
WBCd, UNK, G0 (N=0;1;0;0;0;0;1;0;2;1)	0	1	0	0	0	0	1	0	2	1
WBCd, G0, UNK (N=43;45;44;46;44;46;44;44;42;45)	1	0	2	1	0	0	2	2	1	2
WBCd, G0, G0 (N=43;45;44;46;44;46;44;44;42;45)	41	45	42	44	44	46	41	42	41	43
WBCd, G0, G1 (N=43;45;44;46;44;46;44;44;42;45)	1	0	0	1	0	0	1	0	0	0
WBCd, G1, G0 (N=1;0;1;0;1;0;0;3;2;0)	1	0	1	0	1	0	0	3	2	0
WBCd, G2, G0 (N=0;0;0;0;1;0;0;0;0;0)	0	0	0	0	1	0	0	0	0	0
WBCi, UNK, G0 (N=0;1;0;0;0;0;1;0;2;1)	0	1	0	0	0	0	1	0	2	1
WBCi, G0, UNK (N=42;43;44;44;45;46;42;44;40;44)	1	0	2	1	0	0	2	2	1	2
WBCi, G0, G0 (N=42;43;44;44;45;46;42;44;40;44)	41	43	42	42	45	45	39	39	38	39
WBCi, G0, G1 (N=42;43;44;44;45;46;42;44;40;44)	0	0	0	1	0	1	1	3	1	3
WBCi, G1, G0 (N=2;2;1;2;1;0;2;3;3;1)	1	2	0	1	1	0	1	1	2	0
WBCi, G1, G1 (N=2;2;1;2;1;0;2;3;3;1)	1	0	1	1	0	0	1	2	1	1
WBCi, G2, G1 (N=0;0;0;0;0;0;0;0;1;0)	0	0	0	0	0	0	0	0	1	0

No statistical analyses for this end point

Primary: Number of subjects with change in hematological and biochemical laboratory results from Day 8 to Day 29 versus baseline by toxicity grading

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End point title

Number of subjects with change in hematological and biochemical laboratory results from Day 8 to Day 29 versus baseline by toxicity grading ^[9]

End point description

Hematological parameters assessed are: EOSi, HEMd, LYMd, NEUd, PLTCd, WBCd, WBCi. Biochemical parameters assessed are: ALTi, ASTi, BUN, CRE. Toxicity grading is according to the FDA guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical Trials (September 2007). The grading scale is defined as following: mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4). Category naming has been defined as: Parameter-grading at Baseline-grading at Timing: e.g.: "ALTi-G0-G1" (with G=Grade and UNK=Unknown). The reported results consider any change that occurred during the defined time frame: i.e. any abnormality occurring at an intermediate visit leading to a maximum change from baseline, during the period covered, is the reported result for the outcome.

End point type

Primary

End point timeframe

From Day 8 to Day 29

Notes
[9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This outcome was descriptive; hence no statistical analyses were required.

End point values	D-SUIV Adjuvanted Group 1	D-SUIV Adjuvanted Group 2	D-SUIV Adjuvanted Group 3	D-SUIV Adjuvanted Group 4	D-SUIV Adjuvanted Group 5	D-SUIV Adjuvanted Group 6	D-SUIV Unadjuvanted Group 1	D-SUIV Unadjuvanted Group 2	D-SUIV Unadjuvanted Group 3	IIV4 Group
Number of subjects analysed	44	46	45	46	46	46	44	47	45	46
Units: Participants
ALTi, UNK, G0 (N=0;0;0;0;0;0;1;0;1;0)	0	0	0	0	0	0	0	0	1	0
ALTi, UNK, G1 (N=0;0;0;0;0;0;1;0;1;0)	0	0	0	0	0	0	1	0	0	0
ALTi, G0, UNK (N=40;46;43;45;45;45;44;44;43;46)	0	0	0	0	0	0	1	0	0	0
ALTi, G0, G0 (N=40;46;43;45;45;45;44;44;43;46)	40	45	41	44	45	44	41	43	40	44
ALTi, G0, G1 (N=40;46;43;45;45;45;44;44;43;46)	0	1	2	0	0	1	2	0	3	2
ALTi, G0, G2 (N=40;46;43;45;45;45;44;44;43;46)	0	0	0	0	0	0	0	1	0	0
ALTi, G0, G3 (N=40;46;43;45;45;45;44;44;43;46)	0	0	0	1	0	0	0	0	0	0
ALTi, G1, G0 (N=4;0;2;1;1;1;0;3;2;0)	3	0	1	1	1	0	0	2	2	0
ALTi, G1, G1 (N=4;0;2;1;1;1;0;3;2;0)	1	0	1	0	0	1	0	1	0	0
ASTi, UNK, G0 (N=0;0;0;0;0;0;1;0;1;0)	0	0	0	0	0	0	1	0	1	0
ASTi, G0, UNK (N=44;46;45;46;46;45;43;46;45;46)	0	0	0	0	0	0	1	0	0	0
ASTi, G0, G0 (N=44;46;45;46;46;45;43;46;45;46)	44	46	44	45	46	44	42	43	42	45
ASTi, G0, G1 (N=44;46;45;46;46;45;43;46;45;46)	0	0	1	0	0	1	0	3	2	0
ASTi, G0, G2 (N=44;46;45;46;46;45;43;46;45;46)	0	0	0	0	0	0	0	0	1	1
ASTi, G0, G4 (N=44;46;45;46;46;45;43;46;45;46)	0	0	0	1	0	0	0	0	0	0
ASTi, G1, G0 (N=0;0;0;0;0;1;1;0;0;0)	0	0	0	0	0	0	1	0	0	0
ASTi, G1, G1 (N=0;0;0;0;0;1;1;0;0;0)	0	0	0	0	0	1	0	0	0	0
ASTi, G2, G0 (N=0;0;0;0;0;0;0;1;0;0)	0	0	0	0	0	0	0	1	0	0
BUN, UNK, G0 (N=0;0;0;0;0;0;1;0;1;0)	0	0	0	0	0	0	1	0	1	0
BUN, G0, UNK (N=43;46;45;46;46;46;44;47;43;46)	0	0	0	0	0	0	1	0	0	0
BUN, G0, G0 (N=43;46;45;46;46;46;44;47;43;46)	43	45	45	46	46	46	43	47	43	46
BUN, G0, G1 (N=43;46;45;46;46;46;44;47;43;46)	0	1	0	0	0	0	0	0	0	0
BUN, G1, G0 (N=1;0;0;0;0;0;0;0;1;0)	1	0	0	0	0	0	0	0	1	0
BUN, G2, G0 (N=0;0;0;0;0;0;0;0;1;0)	0	0	0	0	0	0	0	0	1	0
CRE, UNK, G0 (N=0;0;0;0;0;0;1;0;1;0)	0	0	0	0	0	0	1	0	1	0
CRE, G0, UNK (N=44;46;45;46;46;46;44;47;45;46)	0	0	0	0	0	0	1	0	0	0
CRE, G0, G0 (N=44;46;45;46;46;46;44;47;45;46)	44	46	45	46	46	46	43	47	45	46
EOSi, UNK, G0 (N=1;1;3;1;1;1;1;2;5;2)	1	1	3	1	1	1	0	2	5	2
EOSi, UNK, G1 (N=1;1;3;1;1;1;1;2;5;2)	0	0	0	0	0	0	1	0	0	0
EOSi, G0, UNK (N=43;44;41;44;45;45;44;45;40;43)	0	0	0	0	0	0	1	0	0	0
EOSi, G0, G0 (N=43;44;41;44;45;45;44;45;40;43)	43	43	40	44	45	44	40	45	39	43
EOSi, G0, G1 (N=43;44;41;44;45;45;44;45;40;43)	0	1	1	0	0	1	3	0	1	0
EOSi, G1, G0 (N=0;1;1;1;0;0;0;0;1;1)	0	0	1	1	0	0	0	0	0	0
EOSi, G1, G1 (N=0;1;1;1;0;0;0;0;1;1)	0	1	0	0	0	0	0	0	1	1
HEMd, UNK, G0 (N=0;1;0;0;0;0;1;0;0;1)	0	1	0	0	0	0	1	0	0	1
HEMd, G0, G0 (N=39;41;42;42;44;43;39;42;43;43)	37	37	41	38	43	40	37	39	39	42
HEMd, G0, G1 (N=39;41;42;42;44;43;39;42;43;43)	2	4	1	3	1	3	2	3	4	1
HEMd, G0, G2 (N=39;41;42;42;44;43;39;42;43;43)	0	0	0	1	0	0	0	0	0	0
HEMd, G1, UNK (N=3;3;2;4;0;2;4;2;1;2)	0	0	0	0	0	0	1	0	0	0
HEMd, G1, G0 (N=3;3;2;4;0;2;4;2;1;2)	0	0	0	0	0	0	1	2	0	1
HEMd, G1, G1 (N=3;3;2;4;0;2;4;2;1;2)	3	1	2	4	0	1	2	0	0	0
HEMd, G1, G2 (N=3;3;2;4;0;2;4;2;1;2)	0	2	0	0	0	1	0	0	1	1
HEMd, G2, G2 (N=2;0;1;0;2;1;1;2;2;0)	2	0	1	0	2	1	1	0	2	0
HEMd, G2, G3 (N=2;0;1;0;2;1;1;2;2;0)	0	0	0	0	0	0	0	2	0	0
HEMd, G3, G3 (N=0;1;0;0;0;0;0;1;0;0)	0	1	0	0	0	0	0	1	0	0
LYMd, UNK, G0 (N=1;1;3;1;1;1;1;2;5;2)	0	1	3	1	1	1	1	2	5	2
LYMd, UNK, G1 (N=1;1;3;1;1;1;1;2;5;2)	1	0	0	0	0	0	0	0	0	0
LYMd, G0, UNK (N=43;45;39;45;44;45;44;45;39;44)	0	0	0	0	0	0	1	0	0	0
LYMd, G0, G0 (N=43;45;39;45;44;45;44;45;39;44)	41	45	39	45	42	45	43	43	39	41
LYMd, G0, G1 (N=43;45;39;45;44;45;44;45;39;44)	2	0	0	0	1	0	0	2	0	3
LYMd, G0, G2 (N=43;45;39;45;44;45;44;45;39;44)	0	0	0	0	1	0	0	0	0	0
LYMd, G1, G0 (N=0;0;3;0;0;0;0;0;2;0)	0	0	1	0	0	0	0	0	0	0
LYMd, G1, G1 (N=0;0;3;0;0;0;0;0;2;0)	0	0	1	0	0	0	0	0	2	0
LYMd, G1, G2 (N=0;0;3;0;0;0;0;0;2;0)	0	0	1	0	0	0	0	0	0	0
LYMd, G2, G0 (N=0;0;0;0;1;0;0;0;0;0)	0	0	0	0	1	0	0	0	0	0
NEUd, UNK, G0 (N=1;1;3;1;1;1;1;2;5;2)	0	1	3	1	1	1	1	2	2	1
NEUd, UNK, G1 (N=1;1;3;1;1;1;1;2;5;2)	1	0	0	0	0	0	0	0	2	0
NEUd, UNK, G2 (N=1;1;3;1;1;1;1;2;5;2)	0	0	0	0	0	0	0	0	1	1
NEUd, G0, UNK (N=41;41;41;44;41;44;43;41;39;41)	0	0	0	0	0	0	1	0	0	0
NEUd, G0, G0 (N=41;41;41;44;41;44;43;41;39;41)	38	39	40	40	40	42	37	38	38	38
NEUd, G0, G1 (N=41;41;41;44;41;44;43;41;39;41)	3	2	1	2	1	1	2	3	0	2
NEUd, G0, G2 (N=41;41;41;44;41;44;43;41;39;41)	0	0	0	1	0	1	3	0	1	1
NEUd, G0, G3 (N=41;41;41;44;41;44;43;41;39;41)	0	0	0	1	0	0	0	0	0	0
NEUd, G1, G0 (N=2;4;0;1;2;1;1;2;1;1)	1	3	0	0	0	1	0	0	0	0
NEUd, G1, G1 (N=2;4;0;1;2;1;1;2;1;1)	1	1	0	0	1	0	1	1	1	1
NEUd, G1, G2 (N=2;4;0;1;2;1;1;2;1;1)	0	0	0	1	1	0	0	1	0	0
NEUd, G2, G0 (N=0;0;1;0;1;0;0;2;1;2)	0	0	1	0	0	0	0	1	1	1
NEUd, G2, G1 (N=0;0;1;0;1;0;0;2;1;2)	0	0	0	0	1	0	0	1	0	0
NEUd, G2, G2 (N=0;0;1;0;1;0;0;2;1;2)	0	0	0	0	0	0	0	0	0	1
NEUd, G3, G0 (N=0;0;0;0;1;0;0;0;0;0)	0	0	0	0	1	0	0	0	0	0
PLTCd, UNK, G0 (N=0;1;0;0;0;0;1;0;1;1)	0	1	0	0	0	0	1	0	1	1
PLTCd, G0, UNK (N=44;45;45;44;46;46;44;46;44;45)	0	0	0	0	0	0	1	0	0	0
PLTCd, G0, G0 (N=44;45;45;44;46;46;44;46;44;45)	43	45	44	44	46	45	43	46	44	45
PLTCd, G0, G1 (N=44;45;45;44;46;46;44;46;44;45)	1	0	0	0	0	1	0	0	0	0
PLTCd, G0, G2 (N=44;45;45;44;46;46;44;46;44;45)	0	0	1	0	0	0	0	0	0	0
PLTCd, G1, G0 (N=0;0;0;2;0;0;0;1;0;0)	0	0	0	1	0	0	0	1	0	0
PLTCd, G1, G2 (N=0;0;0;2;0;0;0;1;0;0)	0	0	0	1	0	0	0	0	0	0
PLTCd, G2, G1 (N=0;0;0;0;0;0;0;0;1;0)	0	0	0	0	0	0	0	0	1	0
WBCd, UNK, G0 (N=0;1;0;0;0;0;1;0;2;1)	0	1	0	0	0	0	1	0	1	0
WBCd, UNK, G1 (N=0;1;0;0;0;0;1;0;2;1)	0	0	0	0	0	0	0	0	1	1
WBCd, G0, UNK (N=43;45;44;46;44;46;44;44;42;45)	0	0	0	0	0	0	1	0	0	0
WBCd, G0, G0 (N=43;45;44;46;44;46;44;44;42;45)	41	44	44	43	43	46	42	44	41	42
WBCd, G0, G1 (N=43;45;44;46;44;46;44;44;42;45)	2	1	0	3	1	0	1	0	1	3
WBCd, G1, G0 (N=1;0;1;0;1;0;0;3;2;0)	1	0	1	0	1	0	0	3	2	0
WBCd, G2, G0 (N=0;0;0;0;1;0;0;0;0;0)	0	0	0	0	1	0	0	0	0	0
WBCi, UNK, G0 (N=0;1;0;0;0;0;1;0;2;1)	0	1	0	0	0	0	1	0	2	1
WBCi, G0, UNK (N=42;43;44;44;45;46;42;44;40;44)	0	0	0	0	0	0	1	0	0	0
WBCi, G0, G0 (N=42;43;44;44;45;46;42;44;40;44)	42	40	43	42	45	45	38	39	39	41
WBCi, G0, G1 (N=42;43;44;44;45;46;42;44;40;44)	0	3	1	2	0	1	3	5	1	3
WBCi, G1, G0 (N=2;2;1;2;1;0;2;3;3;1)	0	0	0	1	1	0	1	1	2	0
WBCi, G1, G1 (N=2;2;1;2;1;0;2;3;3;1)	1	2	1	1	0	0	1	2	1	1
WBCi, G1, G2 (N=2;2;1;2;1;0;2;3;3;1)	1	0	0	0	0	0	0	0	0	0
WBCi, G2, G1 (N=0;0;0;0;0;0;0;0;1;0)	0	0	0	0	0	0	0	0	1	0

No statistical analyses for this end point

Primary: Number of subjects with change in hematological and biochemical laboratory results from Day 8 to Day 85 versus baseline by toxicity grading

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End point title

Number of subjects with change in hematological and biochemical laboratory results from Day 8 to Day 85 versus baseline by toxicity grading ^[10]

End point description

Hematological parameters assessed are: EOSi, HEMd, LYMd, NEUd, PLTCd, WBCd, WBCi. Biochemical parameters assessed are: ALTi, ASTi, BUN, CRE. Toxicity grading is according to the FDA guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical Trials (September 2007). The grading scale is defined as following: mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4). Category naming has been defined as: Parameter-grading at Baseline-grading at Timing: e.g.: "ALTi-G0-G1" (with G=Grade and UNK= Unknown). The reported results consider any change that occurred during the defined time frame: i.e. any abnormality occurring at an intermediate visit leading to a maximum change from baseline, during the period covered, is the reported result for the outcome.

End point type

Primary

End point timeframe

From Day 8 to Day 85

Notes
[10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This outcome was descriptive; hence no statistical analyses were required.

End point values	D-SUIV Adjuvanted Group 1	D-SUIV Adjuvanted Group 2	D-SUIV Adjuvanted Group 3	D-SUIV Adjuvanted Group 4	D-SUIV Adjuvanted Group 5	D-SUIV Adjuvanted Group 6	D-SUIV Unadjuvanted Group 1	D-SUIV Unadjuvanted Group 2	D-SUIV Unadjuvanted Group 3	IIV4 Group
Number of subjects analysed	44	46	45	46	46	46	44	47	45	46
Units: Participants
ALTi, UNK, G0 (N=0;0;0;0;0;0;1;0;1;0)	0	0	0	0	0	0	0	0	1	0
ALTi, UNK, G1 (N=0;0;0;0;0;0;1;0;1;0)	0	0	0	0	0	0	1	0	0	0
ALTi, G0, UNK (N=40;46;43;45;45;45;44;44;43;46)	0	0	0	0	0	0	1	0	0	0
ALTi, G0, G0 (N=40;46;43;45;45;45;44;44;43;46)	39	42	39	42	44	42	39	39	35	43
ALTi, G0, G1 (N=40;46;43;45;45;45;44;44;43;46)	0	4	4	2	0	3	4	4	8	3
ALTi, G0, G2 (N=40;46;43;45;45;45;44;44;43;46)	0	0	0	0	1	0	0	1	0	0
ALTi, G0, G3 (N=40;46;43;45;45;45;44;44;43;46)	1	0	0	1	0	0	0	0	0	0
ALTi, G1, G0 (N=4;0;2;1;1;1;0;3;2;0)	3	0	1	1	1	0	0	2	2	0
ALTi, G1, G1 (N=4;0;2;1;1;1;0;3;2;0)	1	0	1	0	0	1	0	1	0	0
ASTi, UNK, G0 (N=0;0;0;0;0;0;1;0;1;0)	0	0	0	0	0	0	1	0	1	0
ASTi, G0, UNK (N=44;46;45;46;46;45;43;46;45;46)	0	0	0	0	0	0	1	0	0	0
ASTi, G0, G0 (N=44;46;45;46;46;45;43;46;45;46)	43	44	43	45	43	43	39	43	40	45
ASTi, G0, G1 (N=44;46;45;46;46;45;43;46;45;46)	0	2	2	0	2	2	3	3	4	0
ASTi, G0, G2 (N=44;46;45;46;46;45;43;46;45;46)	0	0	0	0	1	0	0	0	1	1
ASTi, G0, G4 (N=44;46;45;46;46;45;43;46;45;46)	1	0	0	1	0	0	0	0	0	0
ASTi, G1, G1 (N=0;0;0;0;0;1;1;0;0;0)	0	0	0	0	0	1	1	0	0	0
ASTi, G2, G0 (N=0;0;0;0;0;0;0;1;0;0)	0	0	0	0	0	0	0	1	0	0
BUN, UNK, G0 (N=0;0;0;0;0;0;1;0;1;0)	0	0	0	0	0	0	1	0	1	0
BUN, G0, UNK (N=43;46;45;46;46;46;44;47;43;46)	0	0	0	0	0	0	1	0	0	0
BUN, G0, G0 (N=43;46;45;46;46;46;44;47;43;46)	42	45	45	44	45	45	43	46	42	45
BUN, G0, G1 (N=43;46;45;46;46;46;44;47;43;46)	1	1	0	1	1	1	0	1	1	1
BUN, G0, G2 (N=43;46;45;46;46;46;44;47;43;46)	0	0	0	1	0	0	0	0	0	0
BUN, G1, G0 (N=1;0;0;0;0;0;0;0;1;0)	1	0	0	0	0	0	0	0	1	0
BUN, G2, G0 (N=0;0;0;0;0;0;0;0;1;0)	0	0	0	0	0	0	0	0	1	0
CRE, UNK, G0 (N=0;0;0;0;0;0;1;0;1;0)	0	0	0	0	0	0	1	0	1	0
CRE, G0, UNK (N=44;46;45;46;46;46;44;47;45;46)	0	0	0	0	0	0	1	0	0	0
CRE, G0, G0 (N=44;46;45;46;46;46;44;47;45;46)	44	46	45	46	46	46	43	47	45	46
EOSi, UNK, G0 (N=1;1;3;1;1;1;1;2;5;2)	1	1	3	1	1	1	0	2	5	2
EOSi, UNK, G1 (N=1;1;3;1;1;1;1;2;5;2)	0	0	0	0	0	0	1	0	0	0
EOSi, G0, UNK (N=43;44;41;44;45;45;44;45;40;43)	0	0	0	0	0	0	1	0	0	0
EOSi, G0, G0 (N=43;44;41;44;45;45;44;45;40;43)	43	40	39	44	45	44	40	43	36	43
EOSi, G0, G1 (N=43;44;41;44;45;45;44;45;40;43)	0	4	2	0	0	1	3	2	4	0
EOSi, G1, G0 (N=0;1;1;1;0;0;0;0;1;1)	0	0	1	1	0	0	0	0	0	0
EOSi, G1, G1 (N=0;1;1;1;0;0;0;0;1;1)	0	1	0	0	0	0	0	0	1	1
HEMd, UNK, G0 (N=0;1;0;0;0;0;1;0;0;1)	0	1	0	0	0	0	1	0	0	1
HEMd, G0, G0 (N=39;41;42;42;44;43;39;42;43;43)	37	34	41	35	42	37	37	39	39	40
HEMd, G0, G1 (N=39;41;42;42;44;43;39;42;43;43)	2	7	1	6	2	6	2	3	4	3
HEMd, G0, G2 (N=39;41;42;42;44;43;39;42;43;43)	0	0	0	1	0	0	0	0	0	0
HEMd, G1, UNK (N=3;3;2;4;0;2;4;2;1;2)	0	0	0	0	0	0	1	0	0	0
HEMd, G1, G0 (N=3;3;2;4;0;2;4;2;1;2)	0	0	0	0	0	0	0	2	0	1
HEMd, G1, G1 (N=3;3;2;4;0;2;4;2;1;2)	2	1	1	3	0	1	2	0	0	0
HEMd, G1, G2 (N=3;3;2;4;0;2;4;2;1;2)	1	2	1	1	0	1	1	0	1	1
HEMd, G2, G2 (N=2;0;1;0;2;1;1;2;2;0)	1	0	1	0	2	1	1	0	1	0
HEMd, G2, G3 (N=2;0;1;0;2;1;1;2;2;0)	1	0	0	0	0	0	0	2	1	0
HEMd, G3, G3 (N=0;1;0;0;0;0;0;1;0;0)	0	1	0	0	0	0	0	1	0	0
LYMd, UNK, G0 (N=1;1;3;1;1;1;1;2;5;2)	0	1	3	1	1	1	1	2	5	2
LYMd, UNK, G1 (N=1;1;3;1;1;1;1;2;5;2)	1	0	0	0	0	0	0	0	0	0
LYMd, G0, UNK (N=43;45;39;45;44;45;44;45;39;44)	0	0	0	0	0	0	1	0	0	0
LYMd, G0, G0 (N=43;45;39;45;44;45;44;45;39;44)	41	41	39	44	40	44	43	41	38	40
LYMd, G0, G1 (N=43;45;39;45;44;45;44;45;39;44)	2	1	0	1	3	1	0	4	1	4
LYMd, G0, G2 (N=43;45;39;45;44;45;44;45;39;44)	0	2	0	0	1	0	0	0	0	0
LYMd, G0, G3 (N=43;45;39;45;44;45;44;45;39;44)	0	1	0	0	0	0	0	0	0	0
LYMd, G1, G0 (N=0;0;3;0;0;0;0;0;2;0)	0	0	1	0	0	0	0	0	0	0
LYMd, G1, G1 (N=0;0;3;0;0;0;0;0;2;0)	0	0	1	0	0	0	0	0	2	0
LYMd, G1, G2 (N=0;0;3;0;0;0;0;0;2;0)	0	0	1	0	0	0	0	0	0	0
LYMd, G2, G0 (N=0;0;0;0;1;0;0;0;0;0)	0	0	0	0	1	0	0	0	0	0
NEUd, UNK, G0 (N=1;1;3;1;1;1;1;2;5;2)	0	1	2	0	1	0	1	1	2	1
NEUd, UNK, G1 (N=1;1;3;1;1;1;1;2;5;2)	1	0	1	1	0	1	0	0	1	0
NEUd, UNK, G2 (N=1;1;3;1;1;1;1;2;5;2)	0	0	0	0	0	0	0	1	1	1
NEUd, UNK, G3 (N=1;1;3;1;1;1;1;2;5;2)	0	0	0	0	0	0	0	0	1	0
NEUd, G0, UNK (N=41;41;41;44;41;44;43;41;39;41)	0	0	0	0	0	0	1	0	0	0
NEUd, G0, G0 (N=41;41;41;44;41;44;43;41;39;41)	37	35	40	36	37	39	37	35	36	37
NEUd, G0, G1 (N=41;41;41;44;41;44;43;41;39;41)	4	4	1	4	2	4	2	4	2	3
NEUd, G0, G2 (N=41;41;41;44;41;44;43;41;39;41)	0	1	0	2	1	1	3	1	1	1
NEUd, G0, G3 (N=41;41;41;44;41;44;43;41;39;41)	0	1	0	2	1	0	0	1	0	0
NEUd, G1, G0 (N=2;4;0;1;2;1;1;2;1;1)	1	2	0	0	0	1	0	0	0	0
NEUd, G1, G1 (N=2;4;0;1;2;1;1;2;1;1)	1	2	0	0	1	0	0	1	1	1
NEUd, G1, G2 (N=2;4;0;1;2;1;1;2;1;1)	0	0	0	1	1	0	1	1	0	0
NEUd, G2, G0 (N=0;0;1;0;1;0;0;2;1;2)	0	0	1	0	0	0	0	0	0	1
NEUd, G2, G1 (N=0;0;1;0;1;0;0;2;1;2)	0	0	0	0	0	0	0	2	0	0
NEUd, G2, G2 (N=0;0;1;0;1;0;0;2;1;2)	0	0	0	0	1	0	0	0	1	1
NEUd, G3, G1 (N=0;0;0;0;1;0;0;0;0;0)	0	0	0	0	1	0	0	0	0	0
PLTCd, UNK, G0 (N=0;1;0;0;0;0;1;0;1;1)	0	1	0	0	0	0	1	0	1	1
PLTCd, G0, UNK (N=44;45;45;44;46;46;44;46;44;45)	0	0	0	0	0	0	1	0	0	0
PLTCd, G0, G0 (N=44;45;45;44;46;46;44;46;44;45)	42	45	44	43	46	45	43	45	44	45
PLTCd, G0, G1 (N=44;45;45;44;46;46;44;46;44;45)	2	0	0	0	0	1	0	1	0	0
PLTCd, G0, G2 (N=44;45;45;44;46;46;44;46;44;45)	0	0	1	1	0	0	0	0	0	0
PLTCd, G1, G0 (N=0;0;0;2;0;0;0;1;0;0)	0	0	0	1	0	0	0	1	0	0
PLTCd, G1, G3 (N=0;0;0;2;0;0;0;1;0;0)	0	0	0	1	0	0	0	0	0	0
PLTCd, G2, G1 (N=0;0;0;0;0;0;0;0;1;0)	0	0	0	0	0	0	0	0	1	0
WBCd, UNK, G0 (N=0;1;0;0;0;0;1;0;2;1)	0	1	0	0	0	0	1	0	1	0
WBCd, UNK, G1 (N=0;1;0;0;0;0;1;0;2;1)	0	0	0	0	0	0	0	0	1	1
WBCd, G0, UNK (N=43;45;44;46;44;46;44;44;42;45)	0	0	0	0	0	0	1	0	0	0
WBCd, G0, G0 (N=43;45;44;46;44;46;44;44;42;45)	41	43	44	41	41	46	42	42	40	41
WBCd, G0, G1 (N=43;45;44;46;44;46;44;44;42;45)	2	2	0	5	2	0	1	2	2	4
WBCd, G0, G2 (N=43;45;44;46;44;46;44;44;42;45)	0	0	0	0	1	0	0	0	0	0
WBCd, G1, G0 (N=1;0;1;0;1;0;0;3;2;0)	1	0	1	0	1	0	0	2	2	0
WBCd, G1, G1 (N=1;0;1;0;1;0;0;3;2;0)	0	0	0	0	0	0	0	1	0	0
WBCd, G2, G1 (N=0;0;0;0;1;0;0;0;0;0)	0	0	0	0	1	0	0	0	0	0
WBCi, UNK, G0 (N=0;1;0;0;0;0;1;0;2;1)	0	1	0	0	0	0	1	0	2	1
WBCi, G0, UNK (N=42;43;44;44;45;46;42;44;40;44)	0	0	0	0	0	0	1	0	0	0
WBCi, G0, G0 (N=42;43;44;44;45;46;42;44;40;44)	41	39	42	39	45	44	36	39	38	39
WBCi, G0, G1 (N=42;43;44;44;45;46;42;44;40;44)	1	4	2	5	0	2	5	5	1	5
WBCi, G0, G3 (N=42;43;44;44;45;46;42;44;40;44)	0	0	0	0	0	0	0	0	1	0
WBCi, G1, G0 (N=2;2;1;2;1;0;2;3;3;1)	0	0	0	1	1	0	0	1	1	0
WBCi, G1, G1 (N=2;2;1;2;1;0;2;3;3;1)	1	2	1	1	0	0	2	2	2	1
WBCi, G1, G2 (N=2;2;1;2;1;0;2;3;3;1)	1	0	0	0	0	0	0	0	0	0
WBCi, G2, G1 (N=0;0;0;0;0;0;0;0;1;0)	0	0	0	0	0	0	0	0	1	0

No statistical analyses for this end point

Primary: Number of subjects with change in hematological and biochemical laboratory results from Day 8 to Month 14+28 days versus baseline by toxicity grading

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End point title

Number of subjects with change in hematological and biochemical laboratory results from Day 8 to Month 14+28 days versus baseline by toxicity grading ^[11]

End point description

Hematological parameters assessed are: EOSi, HEMd, LYMd, NEUd, PLTCd, WBCd, WBCi. Biochemical parameters assessed are: ALTi, ASTi, BUN, CRE. Toxicity grading is according to the FDA guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical Trials (September 2007). The grading scale is defined as following: mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4). Category naming has been defined as: Parameter-grading at Baseline-grading at Timing: e.g.: "ALTi-G0-G1" (with G=Grade and UNK= Unknown). The reported results consider any change that occurred during the defined time frame: i.e. any abnormality occurring at an intermediate visit leading to a maximum change from baseline, during the period covered, is the reported result for the outcome.

End point type

Primary

End point timeframe

From Day 8 to Month 14 + 28 days

Notes
[11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This outcome was descriptive; hence no statistical analyses were required.

End point values	D-SUIV Adjuvanted Group 1	D-SUIV Adjuvanted Group 2	D-SUIV Adjuvanted Group 3	D-SUIV Adjuvanted Group 4	D-SUIV Adjuvanted Group 5	D-SUIV Adjuvanted Group 6	D-SUIV Unadjuvanted Group 1	D-SUIV Unadjuvanted Group 2	D-SUIV Unadjuvanted Group 3	IIV4 Group
Number of subjects analysed	44	46	45	46	46	46	44	47	45	46
Units: Participants
ALTi, UNK, G0 (N=0;0;0;0;0;0;1;0;1;0)	0	0	0	0	0	0	0	0	1	0
ALTi, UNK, G1 (N=0;0;0;0;0;0;1;0;1;0)	0	0	0	0	0	0	1	0	0	0
ALTi, G0, UNK (N=40;46;43;45;45;45;44;44;43;46)	0	0	0	0	0	0	1	0	0	0
ALTi, G0, G0 (N=40;46;43;45;45;45;44;44;43;46)	38	38	39	42	40	41	38	39	30	40
ALTi, G0, G1 (N=40;46;43;45;45;45;44;44;43;46)	1	8	3	2	4	3	5	4	13	6
ALTi, G0, G2 (N=40;46;43;45;45;45;44;44;43;46)	0	0	1	0	1	1	0	1	0	0
ALTi, G0, G3 (N=40;46;43;45;45;45;44;44;43;46)	1	0	0	1	0	0	0	0	0	0
ALTi, G1, G0 (N=4;0;2;1;1;1;0;3;2;0)	3	0	1	1	1	0	0	2	2	0
ALTi, G1, G1 (N=4;0;2;1;1;1;0;3;2;0)	1	0	1	0	0	1	0	1	0	0
ASTi, UNK, G0 (N=0;0;0;0;0;0;1;0;1;0)	0	0	0	0	0	0	0	0	1	0
ASTi, UNK, G1 (N=0;0;0;0;0;0;1;0;1;0)	0	0	0	0	0	0	1	0	0	0
ASTi, G0, UNK (N=44;46;45;46;46;45;43;46;45;46)	0	0	0	0	0	0	1	0	0	0
ASTi, G0, G0 (N=44;46;45;46;46;45;43;46;45;46)	42	43	41	44	42	43	37	42	37	43
ASTi, G0, G1 (N=44;46;45;46;46;45;43;46;45;46)	1	3	3	1	3	2	5	4	7	2
ASTi, G0, G2 (N=44;46;45;46;46;45;43;46;45;46)	0	0	1	0	1	0	0	0	1	1
ASTi, G0, G4 (N=44;46;45;46;46;45;43;46;45;46)	1	0	0	1	0	0	0	0	0	0
ASTi, G1, G1 (N=0;0;0;0;0;1;1;0;0;0)	0	0	0	0	0	1	1	0	0	0
ASTi, G2, G0 (N=0;0;0;0;0;0;0;1;0;0)	0	0	0	0	0	0	0	1	0	0
BUN, UNK, G0 (N=0;0;0;0;0;0;1;0;1;0)	0	0	0	0	0	0	1	0	1	0
BUN, G0, UNK (N=43;46;45;46;46;46;44;47;43;46)	0	0	0	0	0	0	1	0	0	0
BUN, G0, G0 (N=43;46;45;46;46;46;44;47;43;46)	41	45	45	44	45	45	42	46	41	45
BUN, G0, G1 (N=43;46;45;46;46;46;44;47;43;46)	1	1	0	0	1	1	1	1	2	1
BUN, G0, G2 (N=43;46;45;46;46;46;44;47;43;46)	1	0	0	1	0	0	0	0	0	0
BUN, G0, G3 (N=43;46;45;46;46;46;44;47;43;46)	0	0	0	1	0	0	0	0	0	0
BUN, G1, G0 (N=1;0;0;0;0;0;0;0;1;0)	1	0	0	0	0	0	0	0	1	0
BUN, G2, G0 (N=0;0;0;0;0;0;0;0;1;0)	0	0	0	0	0	0	0	0	1	0
CRE, UNK, G0 (N=0;0;0;0;0;0;1;0;1;0)	0	0	0	0	0	0	1	0	1	0
CRE, G0, UNK (N=44;46;45;46;46;46;44;47;45;46)	0	0	0	0	0	0	1	0	0	0
CRE, G0, G0 (N=44;46;45;46;46;46;44;47;45;46)	44	46	45	46	46	46	43	47	45	46
EOSi, UNK, G0 (N=1;1;3;1;1;1;1;2;5;2)	1	1	3	1	1	1	0	2	5	2
EOSi, UNK, G1 (N=1;1;3;1;1;1;1;2;5;2)	0	0	0	0	0	0	1	0	0	0
EOSi, G0, UNK (N=43;44;41;44;45;45;44;45;40;43)	0	0	0	0	0	0	1	0	0	0
EOSi, G0, G0 (N=43;44;41;44;45;45;44;45;40;43)	42	40	39	43	45	44	39	42	34	43
EOSi, G0, G1 (N=43;44;41;44;45;45;44;45;40;43)	1	4	2	1	0	1	4	3	6	0
EOSi, G1, G0 (N=0;1;1;1;0;0;0;0;1;1)	0	0	1	1	0	0	0	0	0	0
EOSi, G1, G1 (N=0;1;1;1;0;0;0;0;1;1)	0	1	0	0	0	0	0	0	1	1
HEMd, UNK, G0 (N=0;1;0;0;0;0;1;0;0;1)	0	1	0	0	0	0	1	0	0	1
HEMd, G0, G0 (N=39;41;42;42;44;43;39;42;43;43)	35	33	39	33	39	37	35	36	39	39
HEMd, G0, G1 (N=39;41;42;42;44;43;39;42;43;43)	4	8	3	8	5	5	3	6	4	4
HEMd, G0, G2 (N=39;41;42;42;44;43;39;42;43;43)	0	0	0	1	0	1	1	0	0	0
HEMd, G1, UNK (N=3;3;2;4;0;2;4;2;1;2)	0	0	0	0	0	0	1	0	0	0
HEMd, G1, G0 (N=3;3;2;4;0;2;4;2;1;2)	0	0	0	0	0	0	0	2	0	1
HEMd, G1, G1 (N=3;3;2;4;0;2;4;2;1;2)	2	1	1	3	0	1	2	0	0	0
HEMd, G1, G2 (N=3;3;2;4;0;2;4;2;1;2)	0	2	1	1	0	1	1	0	1	1
HEMd, G1, G3 (N=3;3;2;4;0;2;4;2;1;2)	1	0	0	0	0	0	0	0	0	0
HEMd, G2, G2 (N=2;0;1;0;2;1;1;2;2;0)	1	0	1	0	1	1	1	0	1	0
HEMd, G2, G3 (N=2;0;1;0;2;1;1;2;2;0)	0	0	0	0	1	0	0	2	1	0
HEMd, G2, G4 (N=2;0;1;0;2;1;1;2;2;0)	1	0	0	0	0	0	0	0	0	0
HEMd, G3, G3 (N=0;1;0;0;0;0;0;1;0;0)	0	1	0	0	0	0	0	1	0	0
LYMd, UNK, G0 (N=1;1;3;1;1;1;1;2;5;2)	0	0	3	1	1	1	1	2	4	2
LYMd, UNK, G1 (N=1;1;3;1;1;1;1;2;5;2)	1	1	0	0	0	0	0	0	1	0
LYMd, G0, UNK (N=43;45;39;45;44;45;44;45;39;44)	0	0	0	0	0	0	1	0	0	0
LYMd, G0, G0 (N=43;45;39;45;44;45;44;45;39;44)	40	41	39	44	40	44	43	38	38	40
LYMd, G0, G1 (N=43;45;39;45;44;45;44;45;39;44)	3	1	0	1	3	1	0	7	1	4
LYMd, G0, G2 (N=43;45;39;45;44;45;44;45;39;44)	0	2	0	0	1	0	0	0	0	0
LYMd, G0, G3 (N=43;45;39;45;44;45;44;45;39;44)	0	1	0	0	0	0	0	0	0	0
LYMd, G1, G0 (N=0;0;3;0;0;0;0;0;2;0)	0	0	1	0	0	0	0	0	0	0
LYMd, G1, G1 (N=0;0;3;0;0;0;0;0;2;0)	0	0	1	0	0	0	0	0	2	0
LYMd, G1, G2 (N=0;0;3;0;0;0;0;0;2;0)	0	0	1	0	0	0	0	0	0	0
LYMd, G2, G1 (N=0;0;0;0;1;0;0;0;0;0)	0	0	0	0	1	0	0	0	0	0
NEUd, UNK, G0 (N=1;1;3;1;1;1;1;2;5;2)	0	1	2	0	1	0	1	1	2	1
NEUd, UNK, G1 (N=1;1;3;1;1;1;1;2;5;2)	1	0	1	1	0	1	0	0	1	0
NEUd, UNK, G2 (N=1;1;3;1;1;1;1;2;5;2)	0	0	0	0	0	0	0	1	1	1
NEUd, UNK, G3 (N=1;1;3;1;1;1;1;2;5;2)	0	0	0	0	0	0	0	0	1	0
NEUd, G0, UNK (N=41;41;41;44;41;44;43;41;39;41)	0	0	0	0	0	0	1	0	0	0
NEUd, G0, G0 (N=41;41;41;44;41;44;43;41;39;41)	36	34	37	35	36	38	34	35	34	34
NEUd, G0, G1 (N=41;41;41;44;41;44;43;41;39;41)	5	4	2	5	3	5	5	4	4	6
NEUd, G0, G2 (N=41;41;41;44;41;44;43;41;39;41)	0	2	2	2	1	1	3	1	1	1
NEUd, G0, G3 (N=41;41;41;44;41;44;43;41;39;41)	0	1	0	2	1	0	0	1	0	0
NEUd, G1, G0 (N=2;4;0;1;2;1;1;2;1;1)	1	2	0	0	0	1	0	0	0	0
NEUd, G1, G1 (N=2;4;0;1;2;1;1;2;1;1)	0	2	0	0	1	0	0	1	0	1
NEUd, G1, G2 (N=2;4;0;1;2;1;1;2;1;1)	1	0	0	1	1	0	1	1	1	0
NEUd, G2, G0 (N=0;0;1;0;1;0;0;2;1;2)	0	0	1	0	0	0	0	0	0	1
NEUd, G2, G1 (N=0;0;1;0;1;0;0;2;1;2)	0	0	0	0	0	0	0	2	0	0
NEUd, G2, G2 (N=0;0;1;0;1;0;0;2;1;2)	0	0	0	0	1	0	0	0	1	1
NEUd, G3, G1 (N=0;0;0;0;1;0;0;0;0;0)	0	0	0	0	1	0	0	0	0	0
PLTCd, UNK, G0 (N=0;1;0;0;0;0;1;0;1;1)	0	1	0	0	0	0	1	0	1	1
PLTCd, G0, UNK (N=44;45;45;44;46;46;44;46;44;45)	0	0	0	0	0	0	1	0	0	0
PLTCd, G0, G0 (N=44;45;45;44;46;46;44;46;44;45)	42	45	44	43	46	45	43	45	44	45
PLTCd, G0, G1 (N=44;45;45;44;46;46;44;46;44;45)	2	0	0	0	0	1	0	1	0	0
PLTCd, G0, G2 (N=44;45;45;44;46;46;44;46;44;45)	0	0	1	1	0	0	0	0	0	0
PLTCd, G1, G0 (N=0;0;0;2;0;0;0;1;0;0)	0	0	0	1	0	0	0	1	0	0
PLTCd, G1, G3 (N=0;0;0;2;0;0;0;1;0;0)	0	0	0	1	0	0	0	0	0	0
PLTCd, G2, G2 (N=0;0;0;0;0;0;0;0;1;0)	0	0	0	0	0	0	0	0	1	0
WBCd, UNK, G0 (N=0;1;0;0;0;0;1;0;2;1)	0	1	0	0	0	0	1	0	1	0
WBCd, UNK, G1 (N=0;1;0;0;0;0;1;0;2;1)	0	0	0	0	0	0	0	0	1	1
WBCd, G0, UNK (N=43;45;44;46;44;46;44;44;42;45)	0	0	0	0	0	0	1	0	0	0
WBCd, G0, G0 (N=43;45;44;46;44;46;44;44;42;45)	41	42	41	40	41	46	42	41	38	41
WBCd, G0, G1 (N=43;45;44;46;44;46;44;44;42;45)	2	3	3	6	2	0	1	3	4	4
WBCd, G0, G2 (N=43;45;44;46;44;46;44;44;42;45)	0	0	0	0	1	0	0	0	0	0
WBCd, G1, G0 (N=1;0;1;0;1;0;0;3;2;0)	0	0	1	0	1	0	0	2	2	0
WBCd, G1, G1 (N=1;0;1;0;1;0;0;3;2;0)	1	0	0	0	0	0	0	1	0	0
WBCd, G2, G1 (N=0;0;0;0;1;0;0;0;0;0)	0	0	0	0	1	0	0	0	0	0
WBCi, UNK, G0 (N=0;1;0;0;0;0;1;0;2;1)	0	1	0	0	0	0	1	0	2	1
WBCi, G0, UNK (N=42;43;44;44;45;46;42;44;40;44)	0	0	0	0	0	0	1	0	0	0
WBCi, G0, G0 (N=42;43;44;44;45;46;42;44;40;44)	39	39	40	37	43	43	35	37	36	36
WBCi, G0, G1 (N=42;43;44;44;45;46;42;44;40;44)	3	4	4	6	2	3	5	6	3	7
WBCi, G0, G2 (N=42;43;44;44;45;46;42;44;40;44)	0	0	0	1	0	0	1	1	0	1
WBCi, G0, G3 (N=42;43;44;44;45;46;42;44;40;44)	0	0	0	0	0	0	0	0	1	0
WBCi, G1, G0 (N=2;2;1;2;1;0;2;3;3;1)	0	0	0	1	1	0	0	1	1	0
WBCi, G1, G1 (N=2;2;1;2;1;0;2;3;3;1)	1	2	1	1	0	0	2	2	1	1
WBCi, G1, G2 (N=2;2;1;2;1;0;2;3;3;1)	1	0	0	0	0	0	0	0	1	0
WBCi, G2, G1 (N=0;0;0;0;0;0;0;0;1;0)	0	0	0	0	0	0	0	0	1	0

No statistical analyses for this end point

Primary: Number of subjects with change in hematological and biochemical laboratory results from Day 8 to Month 26 versus baseline by toxicity grading

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End point title

Number of subjects with change in hematological and biochemical laboratory results from Day 8 to Month 26 versus baseline by toxicity grading ^[12]

End point description

Hematological parameters assessed are: EOSi, HEMd, LYMd, NEUd, PLTCd, WBCd, WBCi. Biochemical parameters assessed are: ALTi, ASTi, BUN, CRE. Toxicity grading is according to the FDA guidance for industry: Toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical Trials (September 2007). The grading scale is defined as following: mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4). Category naming has been defined as: Parameter-grading at Baseline-grading at Timing: e.g.: "ALTi-G0-G1" (with G=Grade and UNK= Unknown). The reported results consider any change that occurred during the defined time frame: i.e. any abnormality occurring at an intermediate visit leading to a maximum change from baseline, during the period covered, is the reported result for the outcome.

End point type

Primary

End point timeframe

From Day 8 to Month 26

Notes
[12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This outcome was descriptive; hence no statistical analyses were required.

End point values	D-SUIV Adjuvanted Group 1	D-SUIV Adjuvanted Group 2	D-SUIV Adjuvanted Group 3	D-SUIV Adjuvanted Group 4	D-SUIV Adjuvanted Group 5	D-SUIV Adjuvanted Group 6	D-SUIV Unadjuvanted Group 1	D-SUIV Unadjuvanted Group 2	D-SUIV Unadjuvanted Group 3	IIV4 Group
Number of subjects analysed	44	46	45	46	46	46	44	47	45	46
Units: Participants
ALTi, UNK, G0 (N=0;0;0;0;0;0;1;0;1;0)	0	0	0	0	0	0	0	0	1	0
ALTi, UNK, G1 (N=0;0;0;0;0;0;1;0;1;0)	0	0	0	0	0	0	1	0	0	0
ALTi, G0, UNK (N=40;46;43;45;45;45;44;44;43;46)	0	0	0	0	0	0	1	0	0	0
ALTi, G0, G0 (N=40;46;43;45;45;45;44;44;43;46)	38	38	39	42	40	39	37	38	29	40
ALTi, G0, G1 (N=40;46;43;45;45;45;44;44;43;46)	1	8	3	2	4	5	6	5	14	6
ALTi, G0, G2 (N=40;46;43;45;45;45;44;44;43;46)	0	0	1	0	1	1	0	1	0	0
ALTi, G0, G3 (N=40;46;43;45;45;45;44;44;43;46)	1	0	0	1	0	0	0	0	0	0
ALTi, G1, G0 (N=4;0;2;1;1;1;0;3;2;0)	2	0	1	1	1	0	0	2	1	0
ALTi, G1, G1 (N=4;0;2;1;1;1;0;3;2;0)	2	0	1	0	0	1	0	1	1	0
ASTi, UNK, G0 (N=0;0;0;0;0;0;1;0;1;0)	0	0	0	0	0	0	0	0	1	0
ASTi, UNK, G1 (N=0;0;0;0;0;0;1;0;1;0)	0	0	0	0	0	0	1	0	0	0
ASTi, G0, UNK (N=44;46;45;46;46;45;43;46;45;46)	0	0	0	0	0	0	1	0	0	0
ASTi, G0, G0 (N=44;46;45;46;46;45;43;46;45;46)	42	42	41	44	42	42	36	42	37	43
ASTi, G0, G1 (N=44;46;45;46;46;45;43;46;45;46)	1	4	3	1	3	1	6	4	7	2
ASTi, G0, G2 (N=44;46;45;46;46;45;43;46;45;46)	0	0	1	0	1	2	0	0	1	1
ASTi, G0, G4 (N=44;46;45;46;46;45;43;46;45;46)	1	0	0	1	0	0	0	0	0	0
ASTi, G1, G1 (N=0;0;0;0;0;1;1;0;0;0)	0	0	0	0	0	1	1	0	0	0
ASTi, G2, G0 (N=0;0;0;0;0;0;0;1;0;0)	0	0	0	0	0	0	0	1	0	0
BUN, UNK, G0 (N=0;0;0;0;0;0;1;0;1;0)	0	0	0	0	0	0	1	0	1	0
BUN, G0, UNK (N=43;46;45;46;46;46;44;47;43;46)	0	0	0	0	0	0	1	0	0	0
BUN, G0, G0 (N=43;46;45;46;46;46;44;47;43;46)	40	45	45	44	45	45	42	46	41	45
BUN, G0, G1 (N=43;46;45;46;46;46;44;47;43;46)	2	1	0	0	1	1	1	1	2	1
BUN, G0, G2 (N=43;46;45;46;46;46;44;47;43;46)	1	0	0	1	0	0	0	0	0	0
BUN, G0, G3 (N=43;46;45;46;46;46;44;47;43;46)	0	0	0	1	0	0	0	0	0	0
BUN, G1, G0 (N=1; 0;0;0;0;0;0;0;1;0)	1	0	0	0	0	0	0	0	0	0
BUN, G1, G1 (N=1;0;0;0;0;0;0;0;1;0)	0	0	0	0	0	0	0	0	1	0
BUN, G2, G0 (N=0;0;0;0;0;0;0;0;1;0)	0	0	0	0	0	0	0	0	1	0
CRE, UNK, G0 (N=0;0;0;0;0;0;1;0;1;0)	0	0	0	0	0	0	1	0	1	0
CRE, G0, UNK (N=44;46;45;46;46;46;44;47;45;46)	0	0	0	0	0	0	1	0	0	0
CRE, G0, G0 (N=44;46;45;46;46;46;44;47;45;46)	44	46	45	46	46	46	43	47	45	46
EOSi, UNK, G0 (N=1;1;3;1;1;1;1;2;5;2)	1	1	3	1	1	1	0	2	5	2
EOSi, UNK, G1 (N=1;1;3;1;1;1;1;2;5;2)	0	0	0	0	0	0	1	0	0	0
EOSi, G0, UNK (N=43;44;41;44;45;45;44;45;40;43)	0	0	0	0	0	0	1	0	0	0
EOSi, G0, G0 (N=43;44;41;44;45;45;44;45;40;43)	42	40	39	43	45	44	38	41	34	42
EOSi, G0, G1 (N=43;44;41;44;45;45;44;45;40;43)	1	4	2	1	0	1	5	4	6	1
EOSi, G1, G0 (N=0;1;1;1;0;0;0;0;1;1)	0	0	1	1	0	0	0	0	0	0
EOSi, G1, G1 (N=0;1;1;1;0;0;0;0;1;1)	0	1	0	0	0	0	0	0	1	1
HEMd, UNK, G0 (N=0;1;0;0;0;0;1;0;0;1)	0	1	0	0	0	0	1	0	0	1
HEMd, G0, G0 (N=39;41;42;42;44;43;39;42;43;43)	33	32	37	31	38	36	35	35	37	39
HEMd, G0, G1 (N=39;41;42;42;44;43;39;42;43;43)	5	9	5	7	6	6	3	6	5	4
HEMd, G0, G2 (N=39;41;42;42;44;43;39;42;43;43)	1	0	0	4	0	1	1	1	0	0
HEMd, G0, G3 (N=39;41;42;42;44;43;39;42;43;43)	0	0	0	0	0	0	0	0	1	0
HEMd, G1, UNK (N=3;3;2;4;0;2;4;2;1;2)	0	0	0	0	0	0	1	0	0	0
HEMd, G1, G0 (N=3;3;2;4;0;2;4;2;1;2)	0	0	0	0	0	0	0	2	0	1
HEMd, G1, G1 (N=3;3;2;4;0;2;4;2;1;2)	2	1	1	3	0	1	2	0	0	0
HEMd, G1, G2 (N=3;3;2;4;0;2;4;2;1;2)	0	2	1	1	0	1	1	0	1	1
HEMd, G1, G3 (N=3;3;2;4;0;2;4;2;1;2)	1	0	0	0	0	0	0	0	0	0
HEMd, G2, G2 (N=2;0;1;0;2;1;1;2;2;0)	1	0	1	0	1	1	1	0	1	0
HEMd, G2, G3 (N=2;0;1;0;2;1;1;2;2;0)	0	0	0	0	1	0	0	2	1	0
HEMd, G2, G4 (N=2;0;1;0;2;1;1;2;2;0)	1	0	0	0	0	0	0	0	0	0
HEMd, G3, G3 (N=0;1;0;0;0;0;0;1;0;0)	0	1	0	0	0	0	0	1	0	0
LYMd, UNK, G0 (N=1;1;3;1;1;1;1;2;5;2)	0	0	3	1	1	1	1	2	4	2
LYMd, UNK, G1 (N=1;1;3;1;1;1;1;2;5;2)	1	1	0	0	0	0	0	0	1	0
LYMd, G0, UNK (N=43;45;39;45;44;45;44;45;39;44)	0	0	0	0	0	0	1	0	0	0
LYMd, G0, G0 (N=43;45;39;45;44;45;44;45;39;44)	39	40	39	44	40	44	43	37	38	40
LYMd, G0, G1 (N=43;45;39;45;44;45;44;45;39;44)	4	1	0	1	3	1	0	8	1	4
LYMd, G0, G2 (N=43;45;39;45;44;45;44;45;39;44)	0	3	0	0	1	0	0	0	0	0
LYMd, G0, G3 (N=43;45;39;45;44;45;44;45;39;44)	0	1	0	0	0	0	0	0	0	0
LYMd, G1, G0 (N=0;0;3;0;0;0;0;0;2;0)	0	0	1	0	0	0	0	0	0	0
LYMd, G1, G1 (N=0;0;3;0;0;0;0;0;2;0)	0	0	1	0	0	0	0	0	2	0
LYMd, G1, G2 (N=0;0;3;0;0;0;0;0;2;0)	0	0	1	0	0	0	0	0	0	0
LYMd, G2, G1 (N=0;0;0;0;1;0;0;0;0;0)	0	0	0	0	1	0	0	0	0	0
NEUd, UNK, G0 (N=1;1;3;1;1;1;1;2;5;2)	0	1	2	0	1	0	1	1	2	1
NEUd, UNK, G1 (N=1;1;3;1;1;1;1;2;5;2)	1	0	1	1	0	1	0	0	1	0
NEUd, UNK, G2 (N=1;1;3;1;1;1;1;2;5;2)	0	0	0	0	0	0	0	1	1	1
NEUd, UNK, G3 (N=1;1;3;1;1;1;1;2;5;2)	0	0	0	0	0	0	0	0	1	0
NEUd, G0, UNK (N=41;41;41;44;41;44;43;41;39;41)	0	0	0	0	0	0	1	0	0	0
NEUd, G0, G0 (N=41;41;41;44;41;44;43;41;39;41)	35	34	37	35	36	36	34	35	34	34
NEUd, G0, G1 (N=41;41;41;44;41;44;43;41;39;41)	5	4	2	5	3	6	5	4	4	6
NEUd, G0, G2 (N=41;41;41;44;41;44;43;41;39;41)	1	2	2	2	1	2	3	1	1	1
NEUd, G0, G3 (N=41;41;41;44;41;44;43;41;39;41)	0	1	0	2	1	0	0	1	0	0
NEUd, G1, G0 (N=2;4;0;1;2;1;1;2;1;1)	1	2	0	0	0	1	0	0	0	0
NEUd, G1, G1 (N=2;4;0;1;2;1;1;2;1;1)	0	2	0	0	1	0	0	1	0	1
NEUd, G1, G2 (N=2;4;0;1;2;1;1;2;1;1)	1	0	0	1	1	0	1	1	1	0
NEUd, G2, G0 (N=0;0;1;0;1;0;0;2;1;2)	0	0	1	0	0	0	0	0	0	1
NEUd, G2, G1 (N=0;0;1;0;1;0;0;2;1;2)	0	0	0	0	0	0	0	2	0	0
NEUd, G2, G2 (N=0;0;1;0;1;0;0;2;1;2)	0	0	0	0	1	0	0	0	1	1
NEUd, G3, G1 (N=0;0;0;0;1;0;0;0;0;0)	0	0	0	0	1	0	0	0	0	0
PLTCd, UNK, G0 (N=0;1;0;0;0;0;1;0;1;1)	0	1	0	0	0	0	1	0	1	1
PLTCd, G0, UNK (N=44;45;45;44;46;46;44;46;44;45)	0	0	0	0	0	0	1	0	0	0
PLTCd, G0, G0 (N=44;45;45;44;46;46;44;46;44;45)	42	45	44	43	46	44	43	45	44	45
PLTCd, G0, G1 (N=44;45;45;44;46;46;44;46;44;45)	2	0	0	0	0	1	0	1	0	0
PLTCd, G0, G2 (N=44;45;45;44;46;46;44;46;44;45)	0	0	1	1	0	1	0	0	0	0
PLTCd, G1, G0 (N=0;0;0;2;0;0;0;1;0;0)	0	0	0	1	0	0	0	1	0	0
PLTCd, G1, G3 (N=0;0;0;2;0;0;0;1;0;0)	0	0	0	1	0	0	0	0	0	0
PLTCd, G2, G2 (N=0;0;0;0;0;0;0;0;1;0)	0	0	0	0	0	0	0	0	1	0
WBCd, UNK, G0 (N=0;1;0;0;0;0;1;0;2;1)	0	1	0	0	0	0	1	0	1	0
WBCd, UNK, G1 (N=0;1;0;0;0;0;1;0;2;1)	0	0	0	0	0	0	0	0	1	1
WBCd, G0, UNK (N=43;45;44;46;44;46;44;44;42;45)	0	0	0	0	0	0	1	0	0	0
WBCd, G0, G0 (N=43;45;44;46;44;46;44;44;42;45)	39	42	41	40	41	46	42	41	38	41
WBCd, G0, G1 (N=43;45;44;46;44;46;44;44;42;45)	4	3	3	6	2	0	1	3	4	4
WBCd, G0, G2 (N=43;45;44;46;44;46;44;44;42;45)	0	0	0	0	1	0	0	0	0	0
WBCd, G1, G0 (N=1;0;1;0;1;0;0;3;2;0)	0	0	1	0	1	0	0	2	1	0
WBCd, G1, G1 (N=1;0;1;0;1;0;0;3;2;0)	1	0	0	0	0	0	0	1	1	0
WBCd, G2, G1 (N=0;0;0;0;1;0;0;0;0;0)	0	0	0	0	1	0	0	0	0	0
WBCi, UNK, G0 (N=0;1;0;0;0;0;1;0;2;1)	0	1	0	0	0	0	1	0	2	1
WBCi, G0, UNK (N=42;43;44;44;45;46;42;44;40;44)	0	0	0	0	0	0	1	0	0	0
WBCi, G0, G0 (N=42;43;44;44;45;46;42;44;40;44)	37	38	40	37	43	43	35	37	36	36
WBCi, G0, G1 (N=42;43;44;44;45;46;42;44;40;44)	5	5	4	6	2	3	5	6	3	7
WBCi, G0, G2 (N=42;43;44;44;45;46;42;44;40;44)	0	0	0	1	0	0	1	1	0	1
WBCi, G0, G3 (N=42;43;44;44;45;46;42;44;40;44)	0	0	0	0	0	0	0	0	1	0
WBCi, G1, G0 (N=2;2;1;2;1;0;2;3;3;1)	0	0	0	1	1	0	0	1	1	0
WBCi, G1, G1 (N=2;2;1;2;1;0;2;3;3;1)	1	2	1	1	0	0	2	2	1	1
WBCi, G1, G2 (N=2;2;1;2;1;0;2;3;3;1)	1	0	0	0	0	0	0	0	1	0
WBCi, G2, G1 (N=0;0;0;0;0;0;0;0;1;0)	0	0	0	0	0	0	0	0	1	0

No statistical analyses for this end point

Primary: Number of subjects with any medically-attended adverse events (MAEs)

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End point title

Number of subjects with any medically-attended adverse events (MAEs) ^[13]

End point description

MAEs are defined as events for which the subject receives medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.

End point type

Primary

End point timeframe

During the entire study period (from Day 1 up to Month 26)

Notes
[13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This outcome was descriptive; hence no statistical analyses were required.

End point values	D-SUIV Adjuvanted Group 1	D-SUIV Adjuvanted Group 2	D-SUIV Adjuvanted Group 3	D-SUIV Adjuvanted Group 4	D-SUIV Adjuvanted Group 5	D-SUIV Adjuvanted Group 6	D-SUIV Unadjuvanted Group 1	D-SUIV Unadjuvanted Group 2	D-SUIV Unadjuvanted Group 3	IIV4 Group
Number of subjects analysed	45	46	47	47	48	47	47	48	46	47
Units: Participants	21	16	20	23	21	14	19	18	23	20

No statistical analyses for this end point

Primary: Number of subjects reporting any potential immune-mediated diseases (pIMDs)

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End point title

Number of subjects reporting any potential immune-mediated diseases (pIMDs) ^[14]

End point description

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

End point type

Primary

End point timeframe

During the entire study period (from Day 1 up to Month 26)

Notes
[14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This outcome was descriptive; hence no statistical analyses were required.

End point values	D-SUIV Adjuvanted Group 1	D-SUIV Adjuvanted Group 2	D-SUIV Adjuvanted Group 3	D-SUIV Adjuvanted Group 4	D-SUIV Adjuvanted Group 5	D-SUIV Adjuvanted Group 6	D-SUIV Unadjuvanted Group 1	D-SUIV Unadjuvanted Group 2	D-SUIV Unadjuvanted Group 3	IIV4 Group
Number of subjects analysed	45	46	47	47	48	47	47	48	46	47
Units: Participants	0	0	0	0	0	0	1	0	0	0

No statistical analyses for this end point

Primary: Number of subjects with serious adverse events (SAEs).

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End point title

Number of subjects with serious adverse events (SAEs). ^[15]

End point description

SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

End point type

Primary

End point timeframe

During the entire study period (from Day 1 up to Month 26)

Notes
[15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This outcome was descriptive; hence no statistical analyses were required.

End point values	D-SUIV Adjuvanted Group 1	D-SUIV Adjuvanted Group 2	D-SUIV Adjuvanted Group 3	D-SUIV Adjuvanted Group 4	D-SUIV Adjuvanted Group 5	D-SUIV Adjuvanted Group 6	D-SUIV Unadjuvanted Group 1	D-SUIV Unadjuvanted Group 2	D-SUIV Unadjuvanted Group 3	IIV4 Group
Number of subjects analysed	45	46	47	47	48	47	47	48	46	47
Units: Participants	2	1	1	2	2	2	0	2	2	3

No statistical analyses for this end point

Primary: Number of seropositive subjects for anti-H1 stalk antibodies measured by enzyme-linked immunosorbent assay (ELISA)– Day 1

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End point title

Number of seropositive subjects for anti-H1 stalk antibodies measured by enzyme-linked immunosorbent assay (ELISA)– Day 1 ^[16]

End point description

Anti-H1 stalk immune response measured by ELISA. A seropositive subject is a subject whose concentration is greater than or equal to the cut-off value: ELISA cut-off = 66 ELISA.Unit per milliliter (EL.U/mL).

End point type

Primary

End point timeframe

At Day 1

Notes
[16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This outcome was descriptive; hence no statistical analyses were required.

End point values	D-SUIV Adjuvanted Group 1	D-SUIV Adjuvanted Group 2	D-SUIV Adjuvanted Group 3	D-SUIV Adjuvanted Group 4	D-SUIV Adjuvanted Group 5	D-SUIV Adjuvanted Group 6	D-SUIV Unadjuvanted Group 1	D-SUIV Unadjuvanted Group 2	D-SUIV Unadjuvanted Group 3	IIV4 Group
Number of subjects analysed	45	46	47	47	48	47	47	46	44	45
Units: Participants	45	46	47	47	48	47	47	46	44	45

No statistical analyses for this end point

Primary: Number of seropositive subjects for anti-H1 stalk antibodies measured by ELISA– Day 29

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End point title

Number of seropositive subjects for anti-H1 stalk antibodies measured by ELISA– Day 29 ^[17]

End point description

Anti-H1 stalk immune response measured by ELISA. A seropositive subject is a subject whose concentration is greater than or equal to the cut-off value: ELISA cut-off = 66 EL.U/mL.

End point type

Primary

End point timeframe

At Day 29

Notes
[17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This outcome was descriptive; hence no statistical analyses were required.

End point values	D-SUIV Adjuvanted Group 1	D-SUIV Adjuvanted Group 2	D-SUIV Adjuvanted Group 3	D-SUIV Adjuvanted Group 4	D-SUIV Adjuvanted Group 5	D-SUIV Adjuvanted Group 6	D-SUIV Unadjuvanted Group 1	D-SUIV Unadjuvanted Group 2	D-SUIV Unadjuvanted Group 3	IIV4 Group
Number of subjects analysed	43	40	41	40	42	42	37	41	39	40
Units: Participants	43	40	41	40	42	42	37	41	39	40

No statistical analyses for this end point

Primary: Number of seropositive subjects for anti-H1 stalk antibodies measured by ELISA– Day 85

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End point title

Number of seropositive subjects for anti-H1 stalk antibodies measured by ELISA– Day 85 ^[18]

End point description

Anti-H1 stalk immune response measured by ELISA. A seropositive subject is a subject whose concentration is greater than or equal to the cut-off value: ELISA cut-off = 66 EL.U/mL.

End point type

Primary

End point timeframe

At Day 85

Notes
[18] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This outcome was descriptive; hence no statistical analyses were required.

End point values	D-SUIV Adjuvanted Group 1	D-SUIV Adjuvanted Group 2	D-SUIV Adjuvanted Group 3	D-SUIV Adjuvanted Group 4	D-SUIV Adjuvanted Group 5	D-SUIV Adjuvanted Group 6	D-SUIV Unadjuvanted Group 1	D-SUIV Unadjuvanted Group 2	D-SUIV Unadjuvanted Group 3	IIV4 Group
Number of subjects analysed	39	36	34	35	39	35	34	34	35	38
Units: Participants	39	36	34	35	39	35	34	34	35	38

No statistical analyses for this end point

Primary: Concentrations of serum H1 stalk antibodies measured by ELISA– Day 1

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End point title

Concentrations of serum H1 stalk antibodies measured by ELISA– Day 1 ^[19]

End point description

Concentrations are presented as Geometric Mean Concentrations (GMCs) and measured by ELISA. ELISA cut-off = 66 EL.U/mL.

End point type

Primary

End point timeframe

At Day 1

Notes
[19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This outcome was descriptive; hence no statistical analyses were required.

End point values	D-SUIV Adjuvanted Group 1	D-SUIV Adjuvanted Group 2	D-SUIV Adjuvanted Group 3	D-SUIV Adjuvanted Group 4	D-SUIV Adjuvanted Group 5	D-SUIV Adjuvanted Group 6	D-SUIV Unadjuvanted Group 1	D-SUIV Unadjuvanted Group 2	D-SUIV Unadjuvanted Group 3	IIV4 Group
Number of subjects analysed	45	46	47	47	48	47	47	46	44	45
Units: EL.U/mL
geometric mean (confidence interval 95%)	8887.9 (7004.9 to 11277.1)	8719.3 (6547.0 to 11612.3)	9691 (7593.7 to 12367.7)	9121 (7180.0 to 11586.6)	9948.6 (8106.2 to 12209.8)	8555.5 (6980.1 to 10486.4)	9019.6 (7263.5 to 11200.2)	9278.2 (7430.7 to 11585.1)	9039.3 (6930.7 to 11789.5)	9160 (7225.7 to 11612.2)

No statistical analyses for this end point

Primary: Concentrations of serum H1 stalk antibodies measured by ELISA– Day 29

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End point title

Concentrations of serum H1 stalk antibodies measured by ELISA– Day 29 ^[20]

End point description

Concentrations are presented as GMCs and measured by ELISA. ELISA cut-off = 66 EL.U/mL.

End point type

Primary

End point timeframe

At Day 29

Notes
[20] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This outcome was descriptive; hence no statistical analyses were required.

End point values	D-SUIV Adjuvanted Group 1	D-SUIV Adjuvanted Group 2	D-SUIV Adjuvanted Group 3	D-SUIV Adjuvanted Group 4	D-SUIV Adjuvanted Group 5	D-SUIV Adjuvanted Group 6	D-SUIV Unadjuvanted Group 1	D-SUIV Unadjuvanted Group 2	D-SUIV Unadjuvanted Group 3	IIV4 Group
Number of subjects analysed	43	40	41	40	42	42	37	41	39	40
Units: EL.U/mL
geometric mean (confidence interval 95%)	112973.2 (90888.2 to 140424.5)	45645 (35289.4 to 59039.5)	116596.8 (93869.6 to 144826.6)	61634.2 (49810.3 to 76264.7)	46596.2 (38306.7 to 56679.5)	67114.6 (54649.7 to 82422.6)	35580.2 (24654.2 to 51348.2)	20398.6 (16362.4 to 25430.5)	36426.2 (29124.8 to 45558.0)	21938.1 (18037.8 to 26681.8)

No statistical analyses for this end point

Primary: Concentrations of serum H1 stalk antibodies measured by ELISA– Day 85

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End point title

Concentrations of serum H1 stalk antibodies measured by ELISA– Day 85 ^[21]

End point description

Concentrations are presented as GMCs and measured by ELISA. ELISA cut-off = 66 EL.U/mL.

End point type

Primary

End point timeframe

At Day 85

Notes
[21] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This outcome was descriptive; hence no statistical analyses were required.

End point values	D-SUIV Adjuvanted Group 1	D-SUIV Adjuvanted Group 2	D-SUIV Adjuvanted Group 3	D-SUIV Adjuvanted Group 4	D-SUIV Adjuvanted Group 5	D-SUIV Adjuvanted Group 6	D-SUIV Unadjuvanted Group 1	D-SUIV Unadjuvanted Group 2	D-SUIV Unadjuvanted Group 3	IIV4 Group
Number of subjects analysed	39	36	34	35	39	35	34	34	35	38
Units: EL.U/mL
geometric mean (confidence interval 95%)	45351.6 (36766.7 to 55941.1)	28437.5 (21623.4 to 37398.9)	74639.7 (59986.3 to 92872.6)	30419.3 (23619.9 to 39176.0)	25718.6 (20748.8 to 31878.8)	48775.9 (40697.7 to 58457.7)	28617.8 (19448.1 to 42110.9)	15105.9 (12007.7 to 19003.6)	37911.4 (30149.4 to 47671.7)	16749.9 (13471.8 to 20825.8)

No statistical analyses for this end point

Primary: Number of seropositive subjects for anti-H1 stalk antibodies measured by microneutralization (MN) assay – Day 1

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End point title

Number of seropositive subjects for anti-H1 stalk antibodies measured by microneutralization (MN) assay – Day 1 ^[22]

End point description

Anti-H1 stalk immune response measured by MN are expressed in 1/DILUTION (DIL). The functionality of the stalk-reactive antibodies is evaluated by MN assays developed using chimeric viruses. A seropositive subject is a subject whose titer is greater than or equal to the cut-off value: MN cut-off = 20 1/DIL.

End point type

Primary

End point timeframe

At Day 1

Notes
[22] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This outcome was descriptive; hence no statistical analyses were required.

End point values	D-SUIV Adjuvanted Group 1	D-SUIV Adjuvanted Group 2	D-SUIV Adjuvanted Group 3	D-SUIV Adjuvanted Group 4	D-SUIV Adjuvanted Group 5	D-SUIV Adjuvanted Group 6	D-SUIV Unadjuvanted Group 1	D-SUIV Unadjuvanted Group 2	D-SUIV Unadjuvanted Group 3	IIV4 Group
Number of subjects analysed	44	44	45	46	44	46	45	43	42	41
Units: Participants	32	34	35	36	33	40	37	34	31	33

No statistical analyses for this end point

Primary: Number of seropositive subjects for anti-H1 stalk antibodies measured by MN assay – Day 29

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End point title

Number of seropositive subjects for anti-H1 stalk antibodies measured by MN assay – Day 29 ^[23]

End point description

Anti-H1 stalk immune response measured by MN are expressed in 1/DIL. The functionality of the stalk-reactive antibodies is evaluated by MN assays developed using chimeric viruses. A seropositive subject is a subject whose titer is greater than or equal to the cut-off value: MN cut-off = 20 1/DIL.

End point type

Primary

End point timeframe

At Day 29

Notes
[23] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This outcome was descriptive; hence no statistical analyses were required.

End point values	D-SUIV Adjuvanted Group 1	D-SUIV Adjuvanted Group 2	D-SUIV Adjuvanted Group 3	D-SUIV Adjuvanted Group 4	D-SUIV Adjuvanted Group 5	D-SUIV Adjuvanted Group 6	D-SUIV Unadjuvanted Group 1	D-SUIV Unadjuvanted Group 2	D-SUIV Unadjuvanted Group 3	IIV4 Group
Number of subjects analysed	43	40	40	40	41	42	37	41	39	40
Units: Participants	43	40	40	40	41	41	36	41	37	40

No statistical analyses for this end point

Primary: Number of seropositive subjects for anti-H1 stalk antibodies measured by MN assay – Day 85

Top of page

End point title

Number of seropositive subjects for anti-H1 stalk antibodies measured by MN assay – Day 85 ^[24]

End point description

End point type

Primary

End point timeframe

At Day 85

Notes
[24] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This outcome was descriptive; hence no statistical analyses were required.

End point values	D-SUIV Adjuvanted Group 1	D-SUIV Adjuvanted Group 2	D-SUIV Adjuvanted Group 3	D-SUIV Adjuvanted Group 4	D-SUIV Adjuvanted Group 5	D-SUIV Adjuvanted Group 6	D-SUIV Unadjuvanted Group 1	D-SUIV Unadjuvanted Group 2	D-SUIV Unadjuvanted Group 3	IIV4 Group
Number of subjects analysed	38	36	34	33	39	35	34	34	35	38
Units: Participants	36	35	34	31	38	35	30	32	35	37

No statistical analyses for this end point

Primary: Titers for serum H1 stalk antibodies measured by MN assay – Day 1

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End point title

Titers for serum H1 stalk antibodies measured by MN assay – Day 1 ^[25]

End point description

Titers are presented as GMTs and measured by MN assay. MN cut-off = 20 1/DIL.

End point type

Primary

End point timeframe

At Day 1

Notes
[25] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This outcome was descriptive; hence no statistical analyses were required.

End point values	D-SUIV Adjuvanted Group 1	D-SUIV Adjuvanted Group 2	D-SUIV Adjuvanted Group 3	D-SUIV Adjuvanted Group 4	D-SUIV Adjuvanted Group 5	D-SUIV Adjuvanted Group 6	D-SUIV Unadjuvanted Group 1	D-SUIV Unadjuvanted Group 2	D-SUIV Unadjuvanted Group 3	IIV4 Group
Number of subjects analysed	44	44	45	46	44	46	45	43	42	41
Units: Titer
geometric mean (confidence interval 95%)	40.6 (29.4 to 56.1)	45.4 (33.4 to 61.6)	45.9 (34.2 to 61.8)	45.8 (34.5 to 60.8)	41.9 (30.7 to 57.3)	45.1 (35.0 to 58.2)	44.6 (34.4 to 57.7)	43.4 (32.4 to 58.0)	42.7 (31.2 to 58.6)	38 (28.8 to 50.2)

No statistical analyses for this end point

Primary: Titers for serum H1 stalk antibodies measured by MN assay – Day 29

Top of page

End point title

Titers for serum H1 stalk antibodies measured by MN assay – Day 29 ^[26]

End point description

Titers are presented as GMTs and measured by MN assay. MN cut-off = 20 1/DIL.

End point type

Primary

End point timeframe

At Day 29

Notes
[26] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This outcome was descriptive; hence no statistical analyses were required.

End point values	D-SUIV Adjuvanted Group 1	D-SUIV Adjuvanted Group 2	D-SUIV Adjuvanted Group 3	D-SUIV Adjuvanted Group 4	D-SUIV Adjuvanted Group 5	D-SUIV Adjuvanted Group 6	D-SUIV Unadjuvanted Group 1	D-SUIV Unadjuvanted Group 2	D-SUIV Unadjuvanted Group 3	IIV4 Group
Number of subjects analysed	43	40	40	40	41	42	37	41	39	40
Units: Titer
geometric mean (confidence interval 95%)	100.3 (88.1 to 114.1)	109.3 (94.0 to 127.0)	113.1 (96.5 to 132.6)	105.6 (91.0 to 122.5)	96.4 (83.2 to 111.6)	89.8 (73.0 to 110.5)	86.2 (69.9 to 106.3)	80 (66.6 to 96.1)	74.5 (59.6 to 93.2)	87.2 (75.6 to 100.7)

No statistical analyses for this end point

Primary: Titers for serum H1 stalk antibodies measured by MN assay – Day 85

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End point title

Titers for serum H1 stalk antibodies measured by MN assay – Day 85 ^[27]

End point description

Titers are presented as GMTs and measured by MN assay. MN cut-off = 20 1/DIL.

End point type

Primary

End point timeframe

At Day 85

Notes
[27] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This outcome was descriptive; hence no statistical analyses were required.

End point values	D-SUIV Adjuvanted Group 1	D-SUIV Adjuvanted Group 2	D-SUIV Adjuvanted Group 3	D-SUIV Adjuvanted Group 4	D-SUIV Adjuvanted Group 5	D-SUIV Adjuvanted Group 6	D-SUIV Unadjuvanted Group 1	D-SUIV Unadjuvanted Group 2	D-SUIV Unadjuvanted Group 3	IIV4 Group
Number of subjects analysed	38	36	34	33	39	35	34	34	35	38
Units: Titer
geometric mean (confidence interval 95%)	73 (58.3 to 91.5)	98.9 (81.5 to 119.9)	122.7 (108.9 to 138.3)	59.6 (45.9 to 77.4)	87.4 (71.1 to 107.6)	109.8 (93.0 to 129.8)	55.4 (41.3 to 74.3)	75.3 (56.4 to 100.4)	88.3 (74.2 to 105.2)	86.1 (70.2 to 105.5)

No statistical analyses for this end point

Primary: Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk antibody concentration measured by ELISA – Day 29

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End point title

Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk antibody concentration measured by ELISA – Day 29 ^[28]

End point description

Percentage of subjects with an equal or greater than (≥) 4-fold increase of anti-H1 stalk antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA.

End point type

Primary

End point timeframe

At Day 29, compared to pre-vaccination at Day 1

Notes
[28] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This outcome was descriptive; hence no statistical analyses were required.

End point values	D-SUIV Adjuvanted Group 1	D-SUIV Adjuvanted Group 2	D-SUIV Adjuvanted Group 3	D-SUIV Adjuvanted Group 4	D-SUIV Adjuvanted Group 5	D-SUIV Adjuvanted Group 6	D-SUIV Unadjuvanted Group 1	D-SUIV Unadjuvanted Group 2	D-SUIV Unadjuvanted Group 3	IIV4 Group
Number of subjects analysed	43	40	41	40	42	42	37	41	39	40
Units: Percentage of subjects
number (confidence interval 95%)	88.4 (74.9 to 96.1)	60 (43.3 to 75.1)	87.8 (73.8 to 95.9)	70 (53.5 to 83.4)	52.4 (36.4 to 68.0)	83.3 (68.6 to 93.0)	35.1 (20.2 to 52.5)	24.4 (12.4 to 40.3)	38.5 (23.4 to 55.4)	15 (5.7 to 29.8)

No statistical analyses for this end point

Primary: Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk antibody concentration measured by ELISA – Day 85

Top of page

End point title

Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk antibody concentration measured by ELISA – Day 85 ^[29]

End point description

Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA.

End point type

Primary

End point timeframe

At Day 85, compared to pre-vaccination at Day 1

Notes
[29] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This outcome was descriptive; hence no statistical analyses were required.

End point values	D-SUIV Adjuvanted Group 1	D-SUIV Adjuvanted Group 2	D-SUIV Adjuvanted Group 3	D-SUIV Adjuvanted Group 4	D-SUIV Adjuvanted Group 5	D-SUIV Adjuvanted Group 6	D-SUIV Unadjuvanted Group 1	D-SUIV Unadjuvanted Group 2	D-SUIV Unadjuvanted Group 3	IIV4 Group
Number of subjects analysed	39	36	34	35	39	35	34	34	35	38
Units: Percentage of subjects
number (confidence interval 95%)	51.3 (34.8 to 67.6)	44.4 (27.9 to 61.9)	79.4 (62.1 to 91.3)	37.1 (21.5 to 55.1)	20.5 (9.3 to 36.5)	80 (63.1 to 91.6)	29.4 (15.1 to 47.5)	8.8 (1.9 to 23.7)	37.1 (21.5 to 55.1)	7.9 (1.7 to 21.4)

No statistical analyses for this end point

Primary: Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk titer measured by MN assay – Day 29

Top of page

End point title

Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk titer measured by MN assay – Day 29 ^[30]

End point description

Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk antibody titer from Day 1, is calculated with exact 95% CI by MN assay.

End point type

Primary

End point timeframe

At Day 29, compared to pre-vaccination at Day 1

Notes
[30] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This outcome was descriptive; hence no statistical analyses were required.

End point values	D-SUIV Adjuvanted Group 1	D-SUIV Adjuvanted Group 2	D-SUIV Adjuvanted Group 3	D-SUIV Adjuvanted Group 4	D-SUIV Adjuvanted Group 5	D-SUIV Adjuvanted Group 6	D-SUIV Unadjuvanted Group 1	D-SUIV Unadjuvanted Group 2	D-SUIV Unadjuvanted Group 3	IIV4 Group
Number of subjects analysed	42	38	38	39	38	41	35	38	37	36
Units: Percentage of subjects
number (confidence interval 95%)	40.5 (25.6 to 56.7)	39.5 (24.0 to 56.6)	31.6 (17.5 to 48.7)	41 (25.6 to 57.9)	36.8 (21.8 to 54.0)	31.7 (18.1 to 48.1)	34.3 (19.1 to 52.2)	26.3 (13.4 to 43.1)	29.7 (15.9 to 47.0)	36.1 (20.8 to 53.8)

No statistical analyses for this end point

Primary: Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk titer measured by MN assay – Day 85

Top of page

End point title

Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk titer measured by MN assay – Day 85 ^[31]

End point description

Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk antibody titer from Day 1, is calculated with exact 95% CI by MN assay.

End point type

Primary

End point timeframe

At Day 85, compared to pre-vaccination at Day 1

Notes
[31] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This outcome was descriptive; hence no statistical analyses were required.

End point values	D-SUIV Adjuvanted Group 1	D-SUIV Adjuvanted Group 2	D-SUIV Adjuvanted Group 3	D-SUIV Adjuvanted Group 4	D-SUIV Adjuvanted Group 5	D-SUIV Adjuvanted Group 6	D-SUIV Unadjuvanted Group 1	D-SUIV Unadjuvanted Group 2	D-SUIV Unadjuvanted Group 3	IIV4 Group
Number of subjects analysed	37	34	32	33	35	34	33	32	33	34
Units: Percentage of subjects
number (confidence interval 95%)	29.7 (15.9 to 47.0)	38.2 (22.2 to 56.4)	34.4 (18.6 to 53.2)	15.2 (5.1 to 31.9)	31.4 (16.9 to 49.3)	41.2 (24.6 to 59.3)	21.2 (9.0 to 38.9)	18.8 (7.2 to 36.4)	33.3 (18.0 to 51.8)	41.2 (24.6 to 59.3)

No statistical analyses for this end point

Primary: Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody concentration measured by ELISA – Day 29

Top of page

End point title

Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody concentration measured by ELISA – Day 29 ^[32]

End point description

Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA.

End point type

Primary

End point timeframe

At Day 29, compared to pre-vaccination at Day 1

Notes
[32] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This outcome was descriptive; hence no statistical analyses were required.

End point values	D-SUIV Adjuvanted Group 1	D-SUIV Adjuvanted Group 2	D-SUIV Adjuvanted Group 3	D-SUIV Adjuvanted Group 4	D-SUIV Adjuvanted Group 5	D-SUIV Adjuvanted Group 6	D-SUIV Unadjuvanted Group 1	D-SUIV Unadjuvanted Group 2	D-SUIV Unadjuvanted Group 3	IIV4 Group
Number of subjects analysed	43	40	41	40	42	42	37	41	39	40
Units: Percentage of subjects
number (confidence interval 95%)	58.1 (42.1 to 73.0)	35 (20.6 to 51.7)	61 (44.5 to 75.8)	30 (16.6 to 46.5)	21.4 (10.3 to 36.8)	42.9 (27.7 to 59.0)	13.5 (4.5 to 28.8)	2.4 (0.1 to 12.9)	15.4 (5.9 to 30.5)	2.5 (0.1 to 13.2)

No statistical analyses for this end point

Primary: Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody concentration measured by ELISA – Day 85

Top of page

End point title

Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody concentration measured by ELISA – Day 85 ^[33]

End point description

Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody concentration, from Day 1, is calculated with exact 95% CI by ELISA.

End point type

Primary

End point timeframe

At Day 85, compared to pre-vaccination at Day 1

Notes
[33] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This outcome was descriptive; hence no statistical analyses were required.

End point values	D-SUIV Adjuvanted Group 1	D-SUIV Adjuvanted Group 2	D-SUIV Adjuvanted Group 3	D-SUIV Adjuvanted Group 4	D-SUIV Adjuvanted Group 5	D-SUIV Adjuvanted Group 6	D-SUIV Unadjuvanted Group 1	D-SUIV Unadjuvanted Group 2	D-SUIV Unadjuvanted Group 3	IIV4 Group
Number of subjects analysed	39	36	34	35	39	35	34	34	35	38
Units: Percentage of subjects
number (confidence interval 95%)	12.8 (4.3 to 27.4)	5.6 (0.7 to 18.7)	47.1 (29.8 to 64.9)	17.1 (6.6 to 33.6)	5.1 (0.6 to 17.3)	25.7 (12.5 to 43.3)	17.6 (6.8 to 34.5)	2.9 (0.1 to 15.3)	14.3 (4.8 to 30.3)	5.3 (0.6 to 17.7)

No statistical analyses for this end point

Primary: Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk titer measured by MN assay – Day 29

Top of page

End point title

Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk titer measured by MN assay – Day 29 ^[34]

End point description

Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody titer from Day 1, is calculated with exact 95% CI by MN assay.

End point type

Primary

End point timeframe

At Day 29, compared to pre-vaccination at Day 1

Notes
[34] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This outcome was descriptive; hence no statistical analyses were required.

End point values	D-SUIV Adjuvanted Group 1	D-SUIV Adjuvanted Group 2	D-SUIV Adjuvanted Group 3	D-SUIV Adjuvanted Group 4	D-SUIV Adjuvanted Group 5	D-SUIV Adjuvanted Group 6	D-SUIV Unadjuvanted Group 1	D-SUIV Unadjuvanted Group 2	D-SUIV Unadjuvanted Group 3	IIV4 Group
Number of subjects analysed	42	38	38	39	38	41	35	38	37	36
Units: Percentage of subjects
number (confidence interval 95%)	7.1 (1.5 to 19.5)	7.9 (1.7 to 21.4)	10.5 (2.9 to 24.8)	5.1 (0.6 to 17.3)	7.9 (1.7 to 21.4)	4.9 (0.6 to 16.5)	8.6 (1.8 to 23.1)	2.6 (0.1 to 13.8)	2.7 (0.1 to 14.2)	2.8 (0.1 to 14.5)

No statistical analyses for this end point

Primary: Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk titer measured by MN assay – Day 85

Top of page

End point title

Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk titer measured by MN assay – Day 85 ^[35]

End point description

Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody titer from Day 1, is calculated with exact 95% CI by MN assay.

End point type

Primary

End point timeframe

At Day 85, compared to pre-vaccination at Day 1

Notes
[35] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This outcome was descriptive; hence no statistical analyses were required.

End point values	D-SUIV Adjuvanted Group 1	D-SUIV Adjuvanted Group 2	D-SUIV Adjuvanted Group 3	D-SUIV Adjuvanted Group 4	D-SUIV Adjuvanted Group 5	D-SUIV Adjuvanted Group 6	D-SUIV Unadjuvanted Group 1	D-SUIV Unadjuvanted Group 2	D-SUIV Unadjuvanted Group 3	IIV4 Group
Number of subjects analysed	37	34	32	33	35	34	33	32	33	34
Units: Percentage of subjects
number (confidence interval 95%)	2.7 (0.1 to 14.2)	8.8 (1.9 to 23.7)	15.6 (5.3 to 32.8)	3 (0.1 to 15.8)	8.6 (1.8 to 23.1)	8.8 (1.9 to 23.7)	0 (0.0 to 10.6)	6.3 (0.8 to 20.8)	3 (0.1 to 15.8)	2.9 (0.1 to 15.3)

No statistical analyses for this end point

Primary: Mean Geometric Increase (MGI) for anti-H1 stalk antibody concentration measured by ELISA – Day 29

Top of page

End point title

Mean Geometric Increase (MGI) for anti-H1 stalk antibody concentration measured by ELISA – Day 29 ^[36]

End point description

MGI is defined as the geometric mean of the fold increase in serum HI concentration post-vaccination compared to Day 1

End point type

Primary

End point timeframe

At Day 29, compared to pre-vaccination at Day 1

Notes
[36] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This outcome was descriptive; hence no statistical analyses were required.

End point values	D-SUIV Adjuvanted Group 1	D-SUIV Adjuvanted Group 2	D-SUIV Adjuvanted Group 3	D-SUIV Adjuvanted Group 4	D-SUIV Adjuvanted Group 5	D-SUIV Adjuvanted Group 6	D-SUIV Unadjuvanted Group 1	D-SUIV Unadjuvanted Group 2	D-SUIV Unadjuvanted Group 3	IIV4 Group
Number of subjects analysed	43	40	41	40	42	42	37	41	39	40
Units: Ratio
geometric mean (confidence interval 95%)	12.4 (9.2 to 16.7)	5.9 (4.4 to 8.0)	12.6 (9.2 to 17.1)	6.8 (4.9 to 9.5)	4.7 (3.6 to 6.2)	8.1 (6.2 to 10.5)	4.2 (2.9 to 6.2)	2.3 (1.8 to 3.0)	3.9 (2.8 to 5.4)	2.4 (1.9 to 2.9)

No statistical analyses for this end point

Primary: MGI for anti-H1 stalk antibody concentration measured by ELISA – Day 85

Top of page

End point title

MGI for anti-H1 stalk antibody concentration measured by ELISA – Day 85 ^[37]

End point description

MGI is defined as the geometric mean of the fold increase in serum HI concentration post-vaccination compared to Day 1

End point type

Primary

End point timeframe

At Day 85, compared to pre-vaccination at Day 1

Notes
[37] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This outcome was descriptive; hence no statistical analyses were required.

End point values	D-SUIV Adjuvanted Group 1	D-SUIV Adjuvanted Group 2	D-SUIV Adjuvanted Group 3	D-SUIV Adjuvanted Group 4	D-SUIV Adjuvanted Group 5	D-SUIV Adjuvanted Group 6	D-SUIV Unadjuvanted Group 1	D-SUIV Unadjuvanted Group 2	D-SUIV Unadjuvanted Group 3	IIV4 Group
Number of subjects analysed	39	36	34	35	39	35	34	34	35	38
Units: Ratio
geometric mean (confidence interval 95%)	5 (3.9 to 6.5)	3.4 (2.6 to 4.5)	8.1 (6.1 to 10.8)	3.4 (2.4 to 4.9)	2.6 (2.1 to 3.2)	6.3 (5.0 to 7.9)	3.4 (2.3 to 5.0)	1.7 (1.4 to 2.1)	3.8 (2.7 to 5.5)	1.8 (1.5 to 2.3)

No statistical analyses for this end point

Primary: MGI for anti-H1 stalk antibody titer measured by MN assay – Day 29

Top of page

End point title

MGI for anti-H1 stalk antibody titer measured by MN assay – Day 29 ^[38]

End point description

MGI is defined as the geometric mean of the fold increase in serum HI titer post-vaccination compared to Day 1

End point type

Primary

End point timeframe

At Day 29, compared to pre-vaccination at Day 1

Notes
[38] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This outcome was descriptive; hence no statistical analyses were required.

End point values	D-SUIV Adjuvanted Group 1	D-SUIV Adjuvanted Group 2	D-SUIV Adjuvanted Group 3	D-SUIV Adjuvanted Group 4	D-SUIV Adjuvanted Group 5	D-SUIV Adjuvanted Group 6	D-SUIV Unadjuvanted Group 1	D-SUIV Unadjuvanted Group 2	D-SUIV Unadjuvanted Group 3	IIV4 Group
Number of subjects analysed	42	38	38	39	38	41	35	38	37	36
Units: Ratio
geometric mean (confidence interval 95%)	2.4 (1.7 to 3.3)	2.6 (1.9 to 3.6)	2.4 (1.8 to 3.3)	2.3 (1.7 to 3.2)	2.3 (1.7 to 3.2)	2 (1.5 to 2.7)	2.3 (1.7 to 3.2)	1.9 (1.4 to 2.5)	1.7 (1.2 to 2.4)	2.2 (1.6 to 3.1)

No statistical analyses for this end point

Primary: MGI for anti-H1 stalk antibody titer measured by MN assay – Day 85

Top of page

End point title

MGI for anti-H1 stalk antibody titer measured by MN assay – Day 85 ^[39]

End point description

MGI is defined as the geometric mean of the fold increase in serum HI titer post-vaccination compared to Day 1

End point type

Primary

End point timeframe

At Day 85, compared to pre-vaccination at Day 1

Notes
[39] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: This outcome was descriptive; hence no statistical analyses were required.

End point values	D-SUIV Adjuvanted Group 1	D-SUIV Adjuvanted Group 2	D-SUIV Adjuvanted Group 3	D-SUIV Adjuvanted Group 4	D-SUIV Adjuvanted Group 5	D-SUIV Adjuvanted Group 6	D-SUIV Unadjuvanted Group 1	D-SUIV Unadjuvanted Group 2	D-SUIV Unadjuvanted Group 3	IIV4 Group
Number of subjects analysed	37	34	32	33	35	34	33	32	33	34
Units: Ratio
geometric mean (confidence interval 95%)	1.6 (1.2 to 2.2)	2.2 (1.5 to 3.2)	2.5 (1.7 to 3.7)	1.1 (0.8 to 1.6)	2 (1.5 to 2.8)	2.5 (1.7 to 3.5)	1.2 (0.9 to 1.7)	1.6 (1.1 to 2.2)	2 (1.4 to 2.8)	2.4 (1.7 to 3.3)

No statistical analyses for this end point

Secondary: Adjusted GMCs for anti-H1 HA stalk antibody measured by ELISA

Top of page

End point title

Adjusted GMCs for anti-H1 HA stalk antibody measured by ELISA

End point description

The adjusted GMCs are presented to evaluate the adjuvant effect post-dose 1 and post-dose 2.

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Clinical trials

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Number of subjects with solicited local adverse events (AEs) after first dose administration

Primary: Number of subjects with solicited local adverse events (AEs) after first dose administration

Primary: Number of subjects with solicited local AEs after second dose administration

Primary: Number of subjects with solicited local AEs after second dose administration

Primary: Number of subjects with solicited local AEs after booster dose administration

Primary: Number of subjects with solicited local AEs after booster dose administration

Primary: Number of subjects with solicited general AEs after first dose administration

Primary: Number of subjects with solicited general AEs after first dose administration

Primary: Number of subjects with solicited general AEs after second dose administration

Primary: Number of subjects with solicited general AEs after second dose administration

Primary: Number of subjects with solicited general AEs after booster dose administration

Primary: Number of subjects with solicited general AEs after booster dose administration

Primary: Number of subjects with any unsolicited AEs post-vaccination period

Primary: Number of subjects with any unsolicited AEs post-vaccination period

Primary: Number of subjects with change from baseline in hematological and biochemical laboratory results at Day 8 by toxicity grading

Primary: Number of subjects with change from baseline in hematological and biochemical laboratory results at Day 8 by toxicity grading

Primary: Number of subjects with change in hematological and biochemical laboratory results from Day 8 to Day 29 versus baseline by toxicity grading

Primary: Number of subjects with change in hematological and biochemical laboratory results from Day 8 to Day 29 versus baseline by toxicity grading

Primary: Number of subjects with change in hematological and biochemical laboratory results from Day 8 to Day 85 versus baseline by toxicity grading

Primary: Number of subjects with change in hematological and biochemical laboratory results from Day 8 to Day 85 versus baseline by toxicity grading

Primary: Number of subjects with change in hematological and biochemical laboratory results from Day 8 to Month 14+28 days versus baseline by toxicity grading

Primary: Number of subjects with change in hematological and biochemical laboratory results from Day 8 to Month 14+28 days versus baseline by toxicity grading

Primary: Number of subjects with change in hematological and biochemical laboratory results from Day 8 to Month 26 versus baseline by toxicity grading

Primary: Number of subjects with change in hematological and biochemical laboratory results from Day 8 to Month 26 versus baseline by toxicity grading

Primary: Number of subjects with any medically-attended adverse events (MAEs)

Primary: Number of subjects with any medically-attended adverse events (MAEs)

Primary: Number of subjects reporting any potential immune-mediated diseases (pIMDs)

Primary: Number of subjects reporting any potential immune-mediated diseases (pIMDs)

Primary: Number of subjects with serious adverse events (SAEs).

Primary: Number of subjects with serious adverse events (SAEs).

Primary: Number of seropositive subjects for anti-H1 stalk antibodies measured by enzyme-linked immunosorbent assay (ELISA)– Day 1

Primary: Number of seropositive subjects for anti-H1 stalk antibodies measured by enzyme-linked immunosorbent assay (ELISA)– Day 1

Primary: Number of seropositive subjects for anti-H1 stalk antibodies measured by ELISA– Day 29

Primary: Number of seropositive subjects for anti-H1 stalk antibodies measured by ELISA– Day 29

Primary: Number of seropositive subjects for anti-H1 stalk antibodies measured by ELISA– Day 85

Primary: Number of seropositive subjects for anti-H1 stalk antibodies measured by ELISA– Day 85

Primary: Concentrations of serum H1 stalk antibodies measured by ELISA– Day 1

Primary: Concentrations of serum H1 stalk antibodies measured by ELISA– Day 1

Primary: Concentrations of serum H1 stalk antibodies measured by ELISA– Day 29

Primary: Concentrations of serum H1 stalk antibodies measured by ELISA– Day 29

Primary: Concentrations of serum H1 stalk antibodies measured by ELISA– Day 85

Primary: Concentrations of serum H1 stalk antibodies measured by ELISA– Day 85

Primary: Number of seropositive subjects for anti-H1 stalk antibodies measured by microneutralization (MN) assay – Day 1

Primary: Number of seropositive subjects for anti-H1 stalk antibodies measured by microneutralization (MN) assay – Day 1

Primary: Number of seropositive subjects for anti-H1 stalk antibodies measured by MN assay – Day 29

Primary: Number of seropositive subjects for anti-H1 stalk antibodies measured by MN assay – Day 29

Primary: Number of seropositive subjects for anti-H1 stalk antibodies measured by MN assay – Day 85

Primary: Number of seropositive subjects for anti-H1 stalk antibodies measured by MN assay – Day 85

Primary: Titers for serum H1 stalk antibodies measured by MN assay – Day 1

Primary: Titers for serum H1 stalk antibodies measured by MN assay – Day 1

Primary: Titers for serum H1 stalk antibodies measured by MN assay – Day 29

Primary: Titers for serum H1 stalk antibodies measured by MN assay – Day 29

Primary: Titers for serum H1 stalk antibodies measured by MN assay – Day 85

Primary: Titers for serum H1 stalk antibodies measured by MN assay – Day 85

Primary: Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk antibody concentration measured by ELISA – Day 29

Primary: Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk antibody concentration measured by ELISA – Day 29

Primary: Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk antibody concentration measured by ELISA – Day 85

Primary: Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk antibody concentration measured by ELISA – Day 85

Primary: Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk titer measured by MN assay – Day 29

Primary: Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk titer measured by MN assay – Day 29

Primary: Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk titer measured by MN assay – Day 85

Primary: Percentage of subjects with a ≥ 4-fold increase of anti-H1 stalk titer measured by MN assay – Day 85

Primary: Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody concentration measured by ELISA – Day 29

Primary: Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody concentration measured by ELISA – Day 29

Primary: Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody concentration measured by ELISA – Day 85

Primary: Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk antibody concentration measured by ELISA – Day 85

Primary: Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk titer measured by MN assay – Day 29

Primary: Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk titer measured by MN assay – Day 29

Primary: Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk titer measured by MN assay – Day 85

Primary: Percentage of subjects with a ≥ 10-fold increase of anti-H1 stalk titer measured by MN assay – Day 85

Primary: Mean Geometric Increase (MGI) for anti-H1 stalk antibody concentration measured by ELISA – Day 29