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Clinical Trial Results:
A Phase II, Randomized, Controlled, Double-Blind, Dosage and Adjuvant Justification, Safety and Immunogenicity Trial of Intramuscular Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine Adjuvanted with or without Monophosphoryl Lipid A and Aluminum Hydroxide in Adolescents and Adults

Summary
EudraCT number	2013-001419-64
Trial protocol	BE
Global end of trial date	19 Jun 2015

Results information
Results version number	v1(current)
This version publication date	04 Jul 2016
First version publication date	04 Jul 2016
Other versions

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

NOR-107

ISRCTN number

US NCT number

NCT02038907

WHO universal trial number (UTN)

U1111-1147-3239

Sponsor organisation name

Takeda Development Center Americas, Inc.

Sponsor organisation address

One Takeda Parkway, Deerfield, IL, United States, 60015

Public contact

Director, Clinical Science, Takeda, +1 877-825-3327, trialdisclosures@takeda.com

Scientific contact

Director, Clinical Science, Takeda, +1 877-825-3327, trialdisclosures@takeda.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

19 Jun 2015

Is this the analysis of the primary completion data?

Yes

Primary completion date

19 Jun 2015

Global end of trial reached?

Yes

Global end of trial date

19 Jun 2015

Was the trial ended prematurely?

Main objective of the trial

The purpose of this study is to select the optimal formulation of the norovirus vaccine from different concentrations of virus-like particles (VLP) and MPL adjuvant (3-O-desacyl-4’-monophosphoryl lipid A) for further development.

Protection of trial subjects

All study participants were required to read and sign an Informed Consent Form.

Background therapy

Evidence for comparator

Actual start date of recruitment

28 Mar 2014

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Belgium: 420

Worldwide total number of subjects

420

EEA total number of subjects

420

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)

420

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Participants took part in the study at 2 investigative sites in Belgium from 28 March 2014 (first participants signed the informed consent form) to 19 June 2015.

Screening details

Healthy volunteers were enrolled equally in 1 of 14 unique formulation treatment groups: 11 formulation arms received 1 dose and 3 formulation arms received 2 doses.

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, Data analyst, Carer, Assessor

Are arms mutually exclusive

Yes

GI.1/GII.4 (15/15) - MPL (50)

Arm description

Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.

Arm type

Experimental

Investigational medicinal product name

Hepatitis A Vaccine

Investigational medicinal product code

Other name

Havrix

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Hepatitis A vaccine, intramuscular injection (IM)

Investigational medicinal product name

Norovirus Bivalent Virus-Like Particle (VLP) Vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection

GI.1/GII.4 (15/50) - MPL (50)

Arm description

Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.

Arm type

Experimental

Investigational medicinal product name

Hepatitis A Vaccine

Investigational medicinal product code

Other name

Havrix

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Hepatitis A vaccine, intramuscular injection (IM)

Investigational medicinal product name

Norovirus Bivalent Virus-Like Particle (VLP) Vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection

GI.1/GII.4 (50/50) - MPL (50)

Arm description

Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.

Arm type

Experimental

Investigational medicinal product name

Hepatitis A Vaccine

Investigational medicinal product code

Other name

Havrix

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Hepatitis A vaccine, intramuscular injection (IM)

Investigational medicinal product name

Norovirus Bivalent Virus-Like Particle (VLP) Vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection

GI.1/GII.4 (15/15) - MPL (15)

Arm description

Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.

Arm type

Experimental

Investigational medicinal product name

Hepatitis A Vaccine

Investigational medicinal product code

Other name

Havrix

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Hepatitis A vaccine, intramuscular injection (IM)

Investigational medicinal product name

Norovirus Bivalent Virus-Like Particle (VLP) Vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection

GI.1/GII.4 (15/50) - MPL (15)

Arm description

Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.

Arm type

Experimental

Investigational medicinal product name

Hepatitis A Vaccine

Investigational medicinal product code

Other name

Havrix

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Hepatitis A vaccine, intramuscular injection (IM)

Investigational medicinal product name

Norovirus Bivalent Virus-Like Particle (VLP) Vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection

GI.1/GII.4 (50/50) - MPL (15)

Arm description

Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.

Arm type

Experimental

Investigational medicinal product name

Hepatitis A Vaccine

Investigational medicinal product code

Other name

Havrix

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Hepatitis A vaccine, intramuscular injection (IM)

Investigational medicinal product name

Norovirus Bivalent Virus-Like Particle (VLP) Vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection

GI.1/GII.4 (15/15)

Arm description

Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.

Arm type

Experimental

Investigational medicinal product name

Hepatitis A Vaccine

Investigational medicinal product code

Other name

Havrix

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Hepatitis A vaccine, intramuscular injection (IM)

Investigational medicinal product name

Norovirus Bivalent Virus-Like Particle (VLP) Vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection

GI.1/GII.4 (15/50)

Arm description

Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.

Arm type

Experimental

Investigational medicinal product name

Hepatitis A Vaccine

Investigational medicinal product code

Other name

Havrix

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Hepatitis A vaccine, intramuscular injection (IM)

Investigational medicinal product name

Norovirus Bivalent Virus-Like Particle (VLP) Vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection

GI.1/GII.4 (50/50)

Arm description

Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.

Arm type

Experimental

Investigational medicinal product name

Hepatitis A Vaccine

Investigational medicinal product code

Other name

Havrix

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Hepatitis A vaccine, intramuscular injection (IM)

Investigational medicinal product name

Norovirus Bivalent Virus-Like Particle (VLP) Vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection

GI.1/GII.4 (50/150)

Arm description

Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.

Arm type

Experimental

Investigational medicinal product name

Hepatitis A Vaccine

Investigational medicinal product code

Other name

Havrix

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Hepatitis A vaccine, intramuscular injection (IM)

Investigational medicinal product name

Norovirus Bivalent Virus-Like Particle (VLP) Vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection

GI.1/GII.4 (15/50) - Al(OH)3 (167)

Arm description

Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.

Arm type

Experimental

Investigational medicinal product name

Hepatitis A Vaccine

Investigational medicinal product code

Other name

Havrix

Pharmaceutical forms

Suspension for injection

Routes of administration

Intramuscular use

Dosage and administration details

Hepatitis A vaccine, intramuscular injection (IM)

Investigational medicinal product name

Norovirus Bivalent Virus-Like Particle (VLP) Vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection

GI.1/GII.4 (15/50) x2

Arm description

Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.

Arm type

Experimental

Investigational medicinal product name

Norovirus Bivalent Virus-Like Particle (VLP) Vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection

GI.1/GII.4 (50/150) x2

Arm description

Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.

Arm type

Experimental

Investigational medicinal product name

Norovirus Bivalent Virus-Like Particle (VLP) Vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection

GI.1/GII.4 (15/50) - Al(OH)3 (167) x2

Arm description

Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.

Arm type

Experimental

Investigational medicinal product name

Norovirus Bivalent Virus-Like Particle (VLP) Vaccine

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Intramuscular use

Dosage and administration details

Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection

Number of subjects in period 1	GI.1/GII.4 (15/15) - MPL (50)	GI.1/GII.4 (15/50) - MPL (50)	GI.1/GII.4 (50/50) - MPL (50)	GI.1/GII.4 (15/15) - MPL (15)	GI.1/GII.4 (15/50) - MPL (15)	GI.1/GII.4 (50/50) - MPL (15)	GI.1/GII.4 (15/15)	GI.1/GII.4 (15/50)	GI.1/GII.4 (50/50)	GI.1/GII.4 (50/150)	GI.1/GII.4 (15/50) - Al(OH)3 (167)	GI.1/GII.4 (15/50) x2	GI.1/GII.4 (50/150) x2	GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Started	30	30	30	31	30	31	30	32	29	30	29	28	29	31
Completed	30	30	30	31	30	31	30	32	29	30	27	28	29	31
Not completed	0	0	0	0	0	0	0	0	0	0	2	0	0	0
Withdrawal by Subject	-	-	-	-	-	-	-	-	-	-	1	-	-	-
Protocol Violation	-	-	-	-	-	-	-	-	-	-	1	-	-	-

Baseline characteristics

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Reporting group title

GI.1/GII.4 (15/15) - MPL (50)

Reporting group description

Reporting group title

GI.1/GII.4 (15/50) - MPL (50)

Reporting group description

Reporting group title

GI.1/GII.4 (50/50) - MPL (50)

Reporting group description

Reporting group title

GI.1/GII.4 (15/15) - MPL (15)

Reporting group description

Reporting group title

GI.1/GII.4 (15/50) - MPL (15)

Reporting group description

Reporting group title

GI.1/GII.4 (50/50) - MPL (15)

Reporting group description

Reporting group title

GI.1/GII.4 (15/15)

Reporting group description

Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.

Reporting group title

GI.1/GII.4 (15/50)

Reporting group description

Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.

Reporting group title

GI.1/GII.4 (50/50)

Reporting group description

Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.

Reporting group title

GI.1/GII.4 (50/150)

Reporting group description

Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.

Reporting group title

GI.1/GII.4 (15/50) - Al(OH)3 (167)

Reporting group description

Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.

Reporting group title

GI.1/GII.4 (15/50) x2

Reporting group description

Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.

Reporting group title

GI.1/GII.4 (50/150) x2

Reporting group description

Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.

Reporting group title

GI.1/GII.4 (15/50) - Al(OH)3 (167) x2

Reporting group description

Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.

Reporting group values	GI.1/GII.4 (15/15) - MPL (50)	GI.1/GII.4 (15/50) - MPL (50)	GI.1/GII.4 (50/50) - MPL (50)	GI.1/GII.4 (15/15) - MPL (15)	GI.1/GII.4 (15/50) - MPL (15)	GI.1/GII.4 (50/50) - MPL (15)	GI.1/GII.4 (15/15)	GI.1/GII.4 (15/50)	GI.1/GII.4 (50/50)	GI.1/GII.4 (50/150)	GI.1/GII.4 (15/50) - Al(OH)3 (167)	GI.1/GII.4 (15/50) x2	GI.1/GII.4 (50/150) x2	GI.1/GII.4 (15/50) - Al(OH)3 (167) x2	Total
Number of subjects	30	30	30	31	30	31	30	32	29	30	29	28	29	31	420
Age categorical
Units: Subjects
18-49 Years	15	14	15	15	15	15	15	16	15	15	15	14	15	16	210
50-64 Years	15	16	15	16	15	16	15	16	14	15	14	14	14	15	210
Age continuous
Units: years
median (full range (min-max))	50 (19 to 63)	51 (20 to 64)	50 (22 to 64)	50 (20 to 64)	49.5 (20 to 64)	50 (20 to 64)	49.5 (18 to 64)	48.5 (18 to 63)	41 (21 to 63)	51 (20 to 63)	49 (21 to 62)	48.5 (23 to 64)	48 (22 to 63)	44 (19 to 64)	-
Gender categorical
Units: Subjects
Female	18	20	20	22	19	23	15	18	20	23	16	16	20	18	268
Male	12	10	10	9	11	8	15	14	9	7	13	12	9	13	152
Race/Ethnicity, Customized
Units: Subjects
American Indian or Alaska Native	0	0	0	0	0	1	0	0	0	0	0	0	0	0	1
Asian	1	0	0	1	0	1	0	0	1	1	0	0	0	0	5
White	29	30	30	30	30	29	30	32	28	29	29	28	29	31	414
Region of Enrollment
Units: Subjects
Belgium	30	30	30	31	30	31	30	32	29	30	29	28	29	31	420
Height
Units: cm
median (full range (min-max))	173 (156 to 187)	167 (154 to 193)	166.5 (153 to 191)	167 (149 to 187)	171 (155 to 186)	169 (153 to 190)	173.5 (154 to 189)	169.5 (161 to 192)	171 (153 to 193)	167 (153 to 186)	172 (156 to 199)	171.5 (161 to 192)	170 (153 to 187)	175 (146 to 192)	-
Weight
Units: kg
median (full range (min-max))	69.5 (49.4 to 105.2)	65.6 (49.1 to 103)	70.6 (50.8 to 104)	66.6 (42.2 to 103.3)	71.6 (47.6 to 101.9)	68.5 (44 to 96)	72.5 (45.8 to 104.5)	74.35 (52 to 110.3)	76 (54.8 to 101.2)	69.85 (50 to 92.6)	70 (49.6 to 94)	75.5 (42.5 to 92.5)	70.6 (49.2 to 111.8)	69.9 (51 to 111.3)	-
Body Mass ndex (BMI)
Units: kg/m^2
median (full range (min-max))	25.22 (16.7 to 33.6)	23.97 (18.9 to 34.2)	26.11 (17.3 to 33.4)	23.62 (18.7 to 33.7)	24.51 (18.6 to 34.2)	24.73 (17.6 to 34.4)	24.4 (18.1 to 33.7)	24.06 (17.8 to 33.2)	26.06 (19 to 34.6)	25.02 (20 to 34.4)	23.66 (18.1 to 32.3)	24.24 (14.9 to 32.7)	23.19 (18.7 to 33.8)	24.54 (17.9 to 33.5)	-

End points

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Reporting group title

GI.1/GII.4 (15/15) - MPL (50)

Reporting group description

Reporting group title

GI.1/GII.4 (15/50) - MPL (50)

Reporting group description

Reporting group title

GI.1/GII.4 (50/50) - MPL (50)

Reporting group description

Reporting group title

GI.1/GII.4 (15/15) - MPL (15)

Reporting group description

Reporting group title

GI.1/GII.4 (15/50) - MPL (15)

Reporting group description

Reporting group title

GI.1/GII.4 (50/50) - MPL (15)

Reporting group description

Reporting group title

GI.1/GII.4 (15/15)

Reporting group description

Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.

Reporting group title

GI.1/GII.4 (15/50)

Reporting group description

Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.

Reporting group title

GI.1/GII.4 (50/50)

Reporting group description

Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.

Reporting group title

GI.1/GII.4 (50/150)

Reporting group description

Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.

Reporting group title

GI.1/GII.4 (15/50) - Al(OH)3 (167)

Reporting group description

Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.

Reporting group title

GI.1/GII.4 (15/50) x2

Reporting group description

Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.

Reporting group title

GI.1/GII.4 (50/150) x2

Reporting group description

Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.

Reporting group title

GI.1/GII.4 (15/50) - Al(OH)3 (167) x2

Reporting group description

Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.

Primary: Percentage of Participants With a Seroresponse (Pan-Ig ELISA)

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End point title

Percentage of Participants With a Seroresponse (Pan-Ig ELISA) ^[1]

End point description

Seroresponse was defined as 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 virus-Like particle (VLP) and GII.4 VLP as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA). Full Analysis Set included all randomized participants who received at least one dose of trial vaccine.

End point type

Primary

End point timeframe

Baseline and Day 56

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: No statistical analysis is reported for this endpoint.

GI.1/GII.4 (15/15) - MPL (50)

GI.1/GII.4 (15/50) - MPL (50)

GI.1/GII.4 (50/50) - MPL (50)

GI.1/GII.4 (15/15) - MPL (15)

GI.1/GII.4 (15/50) - MPL (15)

GI.1/GII.4 (50/50) - MPL (15)

GI.1/GII.4 (15/15)

GI.1/GII.4 (15/50)

GI.1/GII.4 (50/50)

GI.1/GII.4 (50/150)

GI.1/GII.4 (15/50) - Al(OH)3 (167)

GI.1/GII.4 (15/50) x2

GI.1/GII.4 (50/150) x2

GI.1/GII.4 (15/50) - Al(OH)3 (167) x2

Number of subjects analysed

Units: percentage of participants

number (confidence interval 95%)

43.3 (25.5 to 62.6)

62.1 (42.3 to 79.3)

46.4 (27.5 to 66.1)

35.5 (19.2 to 54.6)

80 (61.4 to 92.3)

67.7 (48.6 to 83.3)

30 (14.7 to 49.4)

62.5 (43.7 to 78.9)

42.9 (24.5 to 62.8)

66.7 (47.2 to 82.7)

46.2 (26.6 to 66.6)

71.4 (51.3 to 86.8)

69 (49.2 to 84.7)

56.7 (37.4 to 74.5)

No statistical analyses for this end point

Primary: Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1

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End point title

Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1 ^[2]

End point description

Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occurred within 7 days after each vaccination. Safety population included all participants who received at least one dose of trial vaccine.

End point type

Primary

End point timeframe

Days 1 through 7

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: No statistical analysis is reported for this endpoint.

End point values	GI.1/GII.4 (15/15) - MPL (50)	GI.1/GII.4 (15/50) - MPL (50)	GI.1/GII.4 (50/50) - MPL (50)	GI.1/GII.4 (15/15) - MPL (15)	GI.1/GII.4 (15/50) - MPL (15)	GI.1/GII.4 (50/50) - MPL (15)	GI.1/GII.4 (15/15)	GI.1/GII.4 (15/50)	GI.1/GII.4 (50/50)	GI.1/GII.4 (50/150)	GI.1/GII.4 (15/50) - Al(OH)3 (167)	GI.1/GII.4 (15/50) x2	GI.1/GII.4 (50/150) x2	GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Number of subjects analysed	30	30	30	31	30	31	30	32	29	30	29	28	29	31
Units: percentage of participants
number (not applicable)
Pain	43.3	33.3	50	32.3	46.7	38.7	40	53.1	44.8	53.3	48.3	46.4	31	32.3
Erythema	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Induration	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Swelling	0	0	0	0	0	0	0	0	3.4	0	0	0	0	0

No statistical analyses for this end point

Primary: Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2

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End point title

Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2 ^[3]

End point description

End point type

Primary

End point timeframe

Days 28 through 34

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: No statistical analysis is reported for this endpoint.

End point values	GI.1/GII.4 (15/15) - MPL (50)	GI.1/GII.4 (15/50) - MPL (50)	GI.1/GII.4 (50/50) - MPL (50)	GI.1/GII.4 (15/15) - MPL (15)	GI.1/GII.4 (15/50) - MPL (15)	GI.1/GII.4 (50/50) - MPL (15)	GI.1/GII.4 (15/15)	GI.1/GII.4 (15/50)	GI.1/GII.4 (50/50)	GI.1/GII.4 (50/150)	GI.1/GII.4 (15/50) - Al(OH)3 (167)	GI.1/GII.4 (15/50) x2	GI.1/GII.4 (50/150) x2	GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Number of subjects analysed	30	30	30	31	30	31	30	32	29	30	29	28	29	31
Units: percentage of participants
number (not applicable)
Pain	60	36.7	66.7	51.6	53.3	58.1	33.3	43.8	48.3	46.7	34.5	32.1	41.4	35.5
Erythema	0	0	3.3	0	0	0	0	0	3.4	3.3	0	0	0	0
Induration	0	0	3.3	0	6.7	0	0	0	3.4	3.3	0	0	0	0
Swelling	0	3.3	0	3.2	0	3.2	0	0	6.9	0	0	0	0	0

No statistical analyses for this end point

Primary: Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1

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End point title

Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1 ^[4]

End point description

Solicited systemic AEs are defined as: headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea that occurred within 7 days after each vaccination. Safety population included all participants who received at least one dose of trial vaccine.

End point type

Primary

End point timeframe

Days 1 through 7

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: No statistical analysis is reported for this endpoint.

End point values	GI.1/GII.4 (15/15) - MPL (50)	GI.1/GII.4 (15/50) - MPL (50)	GI.1/GII.4 (50/50) - MPL (50)	GI.1/GII.4 (15/15) - MPL (15)	GI.1/GII.4 (15/50) - MPL (15)	GI.1/GII.4 (50/50) - MPL (15)	GI.1/GII.4 (15/15)	GI.1/GII.4 (15/50)	GI.1/GII.4 (50/50)	GI.1/GII.4 (50/150)	GI.1/GII.4 (15/50) - Al(OH)3 (167)	GI.1/GII.4 (15/50) x2	GI.1/GII.4 (50/150) x2	GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Number of subjects analysed	30	30	30	31	30	31	30	32	29	30	29	28	29	31
Units: percentage of participants
number (not applicable)
Headache	20	26.7	3.3	19.4	16.7	12.9	13.3	25	27.6	20	13.8	17.9	31	19.4
Fatigue	23.3	23.3	16.7	19.4	10	12.9	13.3	15.6	17.2	20	24.1	25	17.2	22.6
Myalgia	20	6.7	13.3	6.5	3.3	9.7	6.7	18.8	10.3	10	17.2	10.7	3.4	19.4
Arthralgia	0	3.3	6.7	0	3.3	0	3.3	6.3	6.9	3.3	3.4	3.6	3.4	3.2
Vomitting	0	3.3	0	0	0	3.2	0	0	0	3.3	3.4	0	0	0
Diarrhea	0	23.3	3.3	16.1	20	6.5	13.3	12.5	13.8	10	6.9	7.1	10.3	12.9

No statistical analyses for this end point

Primary: Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2

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End point title

Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2 ^[5]

End point description

End point type

Primary

End point timeframe

Days 28 through 34

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: No statistical analysis is reported for this endpoint.

End point values	GI.1/GII.4 (15/15) - MPL (50)	GI.1/GII.4 (15/50) - MPL (50)	GI.1/GII.4 (50/50) - MPL (50)	GI.1/GII.4 (15/15) - MPL (15)	GI.1/GII.4 (15/50) - MPL (15)	GI.1/GII.4 (50/50) - MPL (15)	GI.1/GII.4 (15/15)	GI.1/GII.4 (15/50)	GI.1/GII.4 (50/50)	GI.1/GII.4 (50/150)	GI.1/GII.4 (15/50) - Al(OH)3 (167)	GI.1/GII.4 (15/50) x2	GI.1/GII.4 (50/150) x2	GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Number of subjects analysed	30	30	30	31	30	31	30	32	29	30	29	28	29	31
Units: percentage of participants
number (not applicable)
Headache	13.3	13.3	13.3	22.6	23.3	16.1	10	21.9	20.7	10	13.8	14.3	34.5	19.4
Fatigue	16.7	13.3	20	12.9	10	12.9	10	18.8	17.2	13.3	13.8	7.1	13.8	12.9
Myalgia	13.3	3.3	13.3	0	13.3	12.9	0	6.3	6.9	0	10.3	7.1	0	6.5
Arthralgia	0	3.3	3.3	0	3.3	3.2	0	3.1	0	3.3	3.4	3.6	0	3.2
Vomiting	0	0	0	0	0	0	0	0	0	3.3	3.4	0	0	0
Diarrhea	3.3	10	16.7	12.9	16.7	9.7	6.7	15.6	17.2	10	3.4	7.1	6.9	3.2

No statistical analyses for this end point

Primary: Oral Body Temperature Within 7 Days After Dose 1

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End point title

Oral Body Temperature Within 7 Days After Dose 1 ^[6]

End point description

Oral body temperature measurement is to be performed using the thermometer provided by the site for 7 days after each vaccination. The highest body temperature observed each day will be recorded on the Diary Card also provided by the site. Safety population included all participants who received at least one dose of trial vaccine.

End point type

Primary

End point timeframe

Days 1 through 7

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: No statistical analysis is reported for this endpoint.

End point values	GI.1/GII.4 (15/15) - MPL (50)	GI.1/GII.4 (15/50) - MPL (50)	GI.1/GII.4 (50/50) - MPL (50)	GI.1/GII.4 (15/15) - MPL (15)	GI.1/GII.4 (15/50) - MPL (15)	GI.1/GII.4 (50/50) - MPL (15)	GI.1/GII.4 (15/15)	GI.1/GII.4 (15/50)	GI.1/GII.4 (50/50)	GI.1/GII.4 (50/150)	GI.1/GII.4 (15/50) - Al(OH)3 (167)	GI.1/GII.4 (15/50) x2	GI.1/GII.4 (50/150) x2	GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Number of subjects analysed	30	30	30	30	30	31	30	32	29	30	29	28	29	31
Units: degrees Celsius
arithmetic mean (standard deviation)	36.54 ( 0.294 )	36.76 ( 0.376 )	36.66 ( 0.345 )	36.71 ( 0.26 )	36.65 ( 0.388 )	36.67 ( 0.255 )	36.74 ( 0.323 )	36.63 ( 0.366 )	36.52 ( 0.405 )	36.77 ( 0.341 )	36.71 ( 0.404 )	36.61 ( 0.368 )	36.7 ( 0.362 )	36.61 ( 0.381 )

No statistical analyses for this end point

Primary: Oral Body Temperature Within 7 Days After Dose 2

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End point title

Oral Body Temperature Within 7 Days After Dose 2 ^[7]

End point description

End point type

Primary

End point timeframe

Days 28 through 34

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: No statistical analysis is reported for this endpoint.

End point values	GI.1/GII.4 (15/15) - MPL (50)	GI.1/GII.4 (15/50) - MPL (50)	GI.1/GII.4 (50/50) - MPL (50)	GI.1/GII.4 (15/15) - MPL (15)	GI.1/GII.4 (15/50) - MPL (15)	GI.1/GII.4 (50/50) - MPL (15)	GI.1/GII.4 (15/15)	GI.1/GII.4 (15/50)	GI.1/GII.4 (50/50)	GI.1/GII.4 (50/150)	GI.1/GII.4 (15/50) - Al(OH)3 (167)	GI.1/GII.4 (15/50) x2	GI.1/GII.4 (50/150) x2	GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Number of subjects analysed	30	30	30	31	30	31	30	32	29	30	27	28	29	31
Units: degrees Celsius
arithmetic mean (standard deviation)	36.54 ( 0.282 )	36.76 ( 0.301 )	36.68 ( 0.351 )	36.75 ( 0.466 )	36.6 ( 0.286 )	36.72 ( 0.317 )	36.71 ( 0.394 )	36.64 ( 0.342 )	36.59 ( 0.463 )	36.73 ( 0.293 )	36.68 ( 0.345 )	36.56 ( 0.351 )	36.76 ( 0.391 )	36.61 ( 0.386 )

No statistical analyses for this end point

Primary: Percentage of Participants With Unsolicited Adverse Events (AEs)

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End point title

Percentage of Participants With Unsolicited Adverse Events (AEs) ^[8]

End point description

Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study. Safety population included all participants who received at least one dose of trial vaccine.

End point type

Primary

End point timeframe

Day 1 up to Day 56

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: No statistical analysis is reported for this endpoint.

End point values	GI.1/GII.4 (15/15) - MPL (50)	GI.1/GII.4 (15/50) - MPL (50)	GI.1/GII.4 (50/50) - MPL (50)	GI.1/GII.4 (15/15) - MPL (15)	GI.1/GII.4 (15/50) - MPL (15)	GI.1/GII.4 (50/50) - MPL (15)	GI.1/GII.4 (15/15)	GI.1/GII.4 (15/50)	GI.1/GII.4 (50/50)	GI.1/GII.4 (50/150)	GI.1/GII.4 (15/50) - Al(OH)3 (167)	GI.1/GII.4 (15/50) x2	GI.1/GII.4 (50/150) x2	GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Number of subjects analysed	30	30	30	31	30	31	30	32	29	30	29	28	29	31
Units: percentage of participants
number (not applicable)	56.7	60	53.3	45.2	43.3	54.8	43.3	62.5	69	43.3	48.3	50	51.7	61.3

No statistical analyses for this end point

Primary: Percentage of Participants With Serious Adverse Events (SAEs)

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End point title

Percentage of Participants With Serious Adverse Events (SAEs) ^[9]

End point description

A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Safety population included all participants who received at least one dose of trial vaccine.

End point type

Primary

End point timeframe

Day 1 up to Day 393

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: No statistical analysis is reported for this endpoint.

End point values	GI.1/GII.4 (15/15) - MPL (50)	GI.1/GII.4 (15/50) - MPL (50)	GI.1/GII.4 (50/50) - MPL (50)	GI.1/GII.4 (15/15) - MPL (15)	GI.1/GII.4 (15/50) - MPL (15)	GI.1/GII.4 (50/50) - MPL (15)	GI.1/GII.4 (15/15)	GI.1/GII.4 (15/50)	GI.1/GII.4 (50/50)	GI.1/GII.4 (50/150)	GI.1/GII.4 (15/50) - Al(OH)3 (167)	GI.1/GII.4 (15/50) x2	GI.1/GII.4 (50/150) x2	GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Number of subjects analysed	30	30	30	31	30	31	30	32	29	30	29	28	29	31
Units: percentage of participants
number (not applicable)	6.7	0	16.7	6.5	3.3	0	10	9.4	3.4	3.3	3.4	7.1	3.4	3.2

No statistical analyses for this end point

Secondary: Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)

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End point title

Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)

End point description

Seroresponse was defined as 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 virus-Like particle (VLP) and GII.4 VLP as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA). D=Day Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. “n” in the category is the number of participants with data available at the given time-point.

End point type

Secondary

End point timeframe

Baseline and Days 28, 208 and 393

GI.1/GII.4 (15/15) - MPL (50)

GI.1/GII.4 (15/50) - MPL (50)

GI.1/GII.4 (50/50) - MPL (50)

GI.1/GII.4 (15/15) - MPL (15)

GI.1/GII.4 (15/50) - MPL (15)

GI.1/GII.4 (50/50) - MPL (15)

GI.1/GII.4 (15/15)

GI.1/GII.4 (15/50)

GI.1/GII.4 (50/50)

GI.1/GII.4 (50/150)

GI.1/GII.4 (15/50) - Al(OH)3 (167)

GI.1/GII.4 (15/50) x2

GI.1/GII.4 (50/150) x2

GI.1/GII.4 (15/50) - Al(OH)3 (167) x2

Number of subjects analysed

Units: percentage of participants

number (confidence interval 95%)

D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)

0 (0 to 11.6)

0 (0 to 11.9)

0 (0 to 11.2)

0 (0 to 11.6)

0 (0 to 11.2)

0 (0 to 11.6)

0 (0 to 10.9)

0 (0 to 12.3)

0 (0 to 11.6)

0 (0 to 12.8)

71.4 (51.3 to 86.8)

79.3 (60.3 to 92)

67.7 (48.6 to 83.3)

D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,28)

10 (2.1 to 26.5)

17.2 (5.8 to 35.8)

10 (2.1 to 26.5)

19.4 (7.5 to 37.5)

20 (7.7 to 38.6)

6.7 (0.8 to 22.1)

34.4 (18.6 to 53.2)

17.2 (5.8 to 35.8)

23.3 (9.9 to 42.3)

14.8 (4.2 to 33.7)

32.1 (15.9 to 52.4)

34.5 (17.9 to 54.3)

35.7 (18.6 to 55.9)

D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)

17.2 (5.8 to 35.8)

20.7 (8 to 39.7)

13.3 (3.8 to 30.7)

16.1 (5.5 to 33.7)

10 (2.1 to 26.5)

13.8 (3.9 to 31.7)

10.3 (2.2 to 27.4)

15.6 (5.3 to 32.8)

6.9 (0.8 to 22.8)

13.3 (3.8 to 30.7)

7.4 (0.9 to 24.3)

21.4 (8.3 to 41)

20.7 (8 to 39.7)

No statistical analyses for this end point

Secondary: Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)

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End point title

Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)

End point description

The percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for GI.1 virus-like particle (VLP) as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA). D=Day Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. “n” in the category is the number of participants with data available at the given time-point.

End point type

Secondary

End point timeframe

Baseline and Days 28, 56, 208 and 393

GI.1/GII.4 (15/15) - MPL (50)

GI.1/GII.4 (15/50) - MPL (50)

GI.1/GII.4 (50/50) - MPL (50)

GI.1/GII.4 (15/15) - MPL (15)

GI.1/GII.4 (15/50) - MPL (15)

GI.1/GII.4 (50/50) - MPL (15)

GI.1/GII.4 (15/15)

GI.1/GII.4 (15/50)

GI.1/GII.4 (50/50)

GI.1/GII.4 (50/150)

GI.1/GII.4 (15/50) - Al(OH)3 (167)

GI.1/GII.4 (15/50) x2

GI.1/GII.4 (50/150) x2

GI.1/GII.4 (15/50) - Al(OH)3 (167) x2

Number of subjects analysed

Units: percentage of participants

number (confidence interval 95%)

D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)

0 (0 to 11.6)

0 (0 to 11.9)

0 (0 to 12.8)

6.9 (0.8 to 22.8)

0 (0 to 11.6)

0 (0 to 11.2)

0 (0 to 11.6)

0 (0 to 10.9)

0 (0 to 12.8)

0 (0 to 11.6)

4.2 (0.1 to 21.1)

85.7 (67.3 to 96)

93.1 (77.2 to 99.2)

93.3 (77.9 to 99.2)

D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)

80 (61.4 to 92.3)

89.7 (72.6 to 97.8)

100 (87.7 to 100)

89.7 (72.6 to 97.8)

93.3 (77.9 to 99.2)

96.8 (83.3 to 99.9)

86.7 (69.3 to 96.2)

87.5 (71 to 96.5)

92.9 (76.5 to 99.1)

90 (73.5 to 97.9)

83.3 (62.6 to 95.3)

85.7 (67.3 to 96)

96.6 (82.2 to 99.9)

86.7 (69.3 to 96.2)

D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)

60 (40.6 to 77.3)

65.5 (45.7 to 82.1)

67.9 (47.6 to 84.1)

72.4 (52.8 to 87.3)

70 (50.6 to 85.3)

73.3 (54.1 to 87.7)

66.7 (47.2 to 82.7)

62.5 (43.7 to 78.9)

85.7 (67.3 to 96)

60 (40.6 to 77.3)

54.2 (32.8 to 74.4)

71.4 (51.3 to 86.8)

75.9 (56.5 to 89.7)

74.1 (53.7 to 88.9)

D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)

55.2 (35.7 to 73.6)

46.4 (27.5 to 66.1)

67.9 (47.6 to 84.1)

69 (49.2 to 84.7)

63.3 (43.9 to 80.1)

65.5 (45.7 to 82.1)

55.2 (35.7 to 73.6)

53.1 (34.7 to 70.9)

82.1 (63.1 to 93.9)

43.3 (25.5 to 62.6)

45.8 (25.6 to 67.2)

64.3 (44.1 to 81.4)

72.4 (52.8 to 87.3)

78.6 (59 to 91.7)

No statistical analyses for this end point

Secondary: Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)

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End point title

Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)

End point description

The percentage of participants with a 4-fold rise or greater from in serum anti-norovirus antibody titers for GII.4 virus-like particle (VLP) as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA). D=Day Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. “n” in the category is the number of participants with data available at the given time-point.

End point type

Secondary

End point timeframe

Baseline and Days 28, 56, 208 and 393

GI.1/GII.4 (15/15) - MPL (50)

GI.1/GII.4 (15/50) - MPL (50)

GI.1/GII.4 (50/50) - MPL (50)

GI.1/GII.4 (15/15) - MPL (15)

GI.1/GII.4 (15/50) - MPL (15)

GI.1/GII.4 (50/50) - MPL (15)

GI.1/GII.4 (15/15)

GI.1/GII.4 (15/50)

GI.1/GII.4 (50/50)

GI.1/GII.4 (50/150)

GI.1/GII.4 (15/50) - Al(OH)3 (167)

GI.1/GII.4 (15/50) x2

GI.1/GII.4 (50/150) x2

GI.1/GII.4 (15/50) - Al(OH)3 (167) x2

Number of subjects analysed

Units: percentage of participants

number (confidence interval 95%)

D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)

0 (0 to 11.6)

0 (0 to 11.9)

0 (0 to 12.8)

0 (0 to 11.9)

0 (0 to 11.6)

0 (0 to 11.2)

3.3 (0.1 to 17.2)

3.1 (0.1 to 16.2)

0 (0 to 12.8)

3.3 (0.1 to 17.2)

0 (0 to 14.2)

78.6 (59 to 91.7)

86.2 (68.3 to 96.1)

70 (50.6 to 85.3)

D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)

50 (31.3 to 68.7)

65.5 (45.7 to 82.1)

46.4 (27.5 to 66.1)

41.4 (23.5 to 61.1)

83.3 (65.3 to 94.4)

71 (52 to 85.8)

33.3 (17.3 to 52.8)

71.9 (53.3 to 86.3)

42.9 (24.5 to 62.8)

73.3 (54.1 to 87.7)

54.2 (32.8 to 74.4)

78.6 (59 to 91.7)

72.4 (52.8 to 87.3)

63.3 (43.9 to 80.1)

D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)

16.7 (5.6 to 34.7)

27.6 (12.7 to 47.2)

7.1 (0.9 to 23.5)

27.6 (12.7 to 47.2)

36.7 (19.9 to 56.1)

23.3 (9.9 to 42.3)

16.7 (5.6 to 34.7)

46.9 (29.1 to 65.3)

14.3 (4 to 32.7)

30 (14.7 to 49.4)

16.7 (4.7 to 37.4)

35.7 (18.6 to 55.9)

41.4 (23.5 to 61.1)

33.3 (16.5 to 54)

D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)

20.7 (8 to 39.7)

32.1 (15.9 to 52.4)

10.7 (2.3 to 28.2)

27.6 (12.7 to 47.2)

20 (7.7 to 38.6)

17.2 (5.8 to 35.8)

21.9 (9.3 to 40)

10.7 (2.3 to 28.2)

13.3 (3.8 to 30.7)

8.3 (1 to 27)

28.6 (13.2 to 48.7)

27.6 (12.7 to 47.2)

21.4 (8.3 to 41)

No statistical analyses for this end point

Secondary: Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)

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End point title

Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)

End point description

Geometric mean titer (GMT) of anti-norovirus GI.1 VLP antibody titers as measured by pan-Ig ELISA. D=Day Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. “n” in the category is the number of participants with data available at the given time-point.

End point type

Secondary

End point timeframe

Day 1 (Baseline) and Days 28, 56, 208 and 393

End point values	GI.1/GII.4 (15/15) - MPL (50)	GI.1/GII.4 (15/50) - MPL (50)	GI.1/GII.4 (50/50) - MPL (50)	GI.1/GII.4 (15/15) - MPL (15)	GI.1/GII.4 (15/50) - MPL (15)	GI.1/GII.4 (50/50) - MPL (15)	GI.1/GII.4 (15/15)	GI.1/GII.4 (15/50)	GI.1/GII.4 (50/50)	GI.1/GII.4 (50/150)	GI.1/GII.4 (15/50) - Al(OH)3 (167)	GI.1/GII.4 (15/50) x2	GI.1/GII.4 (50/150) x2	GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Number of subjects analysed	30	30	30	31	30	31	30	32	29	30	29	28	29	31
Units: titer
geometric mean (standard deviation)
D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)	833.4 ( 4.64 )	790.3 ( 4.5 )	636.7 ( 4.6 )	647.6 ( 5.17 )	625.3 ( 2.96 )	520.3 ( 4.99 )	890.5 ( 4.75 )	842.9 ( 4.92 )	677.2 ( 3.75 )	827.3 ( 4.82 )	856.7 ( 5.34 )	741.5 ( 5.28 )	897.5 ( 3.74 )	742.7 ( 3.69 )
D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)	798.9 ( 4.66 )	737.9 ( 4.42 )	548.5 ( 4.47 )	806.6 ( 5.36 )	573.6 ( 3.08 )	514.6 ( 5.19 )	910.4 ( 4.37 )	821.5 ( 4.84 )	638.5 ( 3.9 )	780.6 ( 5.11 )	889.7 ( 5.34 )	14488.6 ( 3 )	20839.2 ( 1.96 )	15967.7 ( 2.39 )
D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)	14417.7 ( 2.74 )	14171.3 ( 2.76 )	17504.8 ( 2.64 )	14220.4 ( 3.23 )	13982.2 ( 2.33 )	18266 ( 1.99 )	16082.5 ( 2.07 )	15974.2 ( 3.95 )	25808.9 ( 2.55 )	154663 ( 2.59 )	14045.2 ( 2.94 )	12613.2 ( 2.46 )	17696.3 ( 1.92 )	12235.7 ( 2.11 )
D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)	5725.2 ( 2.37 )	5069.7 ( 2.48 )	6084.3 ( 2.43 )	5613.9 ( 2.68 )	4467.6 ( 2.05 )	5106.4 ( 2.06 )	5660.5 ( 2.22 )	7174.8 ( 2.47 )	7542 ( 2.28 )	5361.1 ( 2.37 )	5162.8 ( 2.18 )	6863.9 ( 2.27 )	7459.1 ( 1.72 )	5912.6 ( 1.94 )
D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)	3886 ( 2.98 )	3179.7 ( 2.78 )	4470.4 ( 2.55 )	5009 ( 2.8 )	3209.6 ( 2.54 )	3874.5 ( 2.55 )	4940.3 ( 2.48 )	4773.3 ( 2.62 )	5550.1 ( 2.7 )	3542.9 ( 2.54 )	3960 ( 2.55 )	4715.8 ( 2.51 )	5686.7 ( 2.17 )	4404.7 ( 2.19 )

No statistical analyses for this end point

Secondary: Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)

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End point title

Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)

End point description

Geometric mean titer (GMT) of anti-norovirus GII.4 VLP antibody titers as measured by pan-Ig ELISA. D=Day Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. “n” in the category is the number of participants with data available at the given time-point.

End point type

Secondary

End point timeframe

Day 1 (Baseline) and Days 28, 56, 208 and 393

End point values	GI.1/GII.4 (15/15) - MPL (50)	GI.1/GII.4 (15/50) - MPL (50)	GI.1/GII.4 (50/50) - MPL (50)	GI.1/GII.4 (15/15) - MPL (15)	GI.1/GII.4 (15/50) - MPL (15)	GI.1/GII.4 (50/50) - MPL (15)	GI.1/GII.4 (15/15)	GI.1/GII.4 (15/50)	GI.1/GII.4 (50/50)	GI.1/GII.4 (50/150)	GI.1/GII.4 (15/50) - Al(OH)3 (167)	GI.1/GII.4 (15/50) x2	GI.1/GII.4 (50/150) x2	GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Number of subjects analysed	30	30	30	31	30	31	30	32	29	30	29	28	29	31
Units: titer
geometric mean (standard deviation)
D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)	1106.6 ( 4.68 )	1249.2 ( 3.45 )	1477.7 ( 4.13 )	1109.2 ( 4.1 )	921.7 ( 3.15 )	1130.9 ( 4.18 )	1340.4 ( 4.08 )	1238.6 ( 3.92 )	1201.2 ( 3.57 )	1473.2 ( 3.88 )	1832.3 ( 2.69 )	977.7 ( 3.73 )	1324.4 ( 3.34 )	1647 ( 3.39 )
D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)	1016.8 ( 5.56 )	1232.6 ( 3.46 )	1540.6 ( 3.83 )	1110.4 ( 3.84 )	839.4 ( 3.04 )	1097.8 ( 4.14 )	1268.1 ( 3.68 )	1311 ( 3.98 )	1139.9 ( 3.48 )	1494.7 ( 3.05 )	1924.8 ( 2.52 )	8459.4 ( 2.19 )	12901.7 ( 2.12 )	11116.3 ( 2.55 )
D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)	4595.7 ( 3 )	8636.7 ( 2.05 )	5750.4 ( 2.15 )	4391.5 ( 2.66 )	7545.2 ( 2.61 )	7802.7 ( 2.03 )	3444.6 ( 2.92 )	9945.7 ( 2.98 )	5129.9 ( 2.91 )	10624.2 ( 2.15 )	10034.2 ( 1.96 )	6622 ( 2.22 )	9995.5 ( 2.13 )	8164 ( 2.32 )
D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)	2341.2 ( 3.93 )	3653 ( 2.24 )	2993.2 ( 3.61 )	2887.7 ( 2.78 )	2984.6 ( 2.62 )	3212.2 ( 2.44 )	2251.1 ( 3.15 )	5017.6 ( 2.82 )	2615.1 ( 2.91 )	4531.4 ( 2.21 )	4667 ( 2.2 )	3837.9 ( 2.3 )	4693.8 ( 2.52 )	4546.8 ( 2.26 )
D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)	2236.5 ( 3.84 )	3103 ( 3.03 )	2450.2 ( 2.87 )	2175.3 ( 2.91 )	1946.4 ( 2.51 )	2173.7 ( 2.73 )	2267.2 ( 3.29 )	2969.9 ( 2.92 )	1898.2 ( 3.41 )	2550 ( 2.29 )	2871.1 ( 2.43 )	2425.1 ( 2.46 )	3133 ( 2.5 )	3060.7 ( 2.44 )

No statistical analyses for this end point

Secondary: Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)

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End point title

Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)

End point description

Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by pan-Ig ELISA. D=Day Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. “n” in the category is the number of participants with data available at the given time-point.

End point type

Secondary

End point timeframe

Days 28, 56, 208 and 393

End point values	GI.1/GII.4 (15/15) - MPL (50)	GI.1/GII.4 (15/50) - MPL (50)	GI.1/GII.4 (50/50) - MPL (50)	GI.1/GII.4 (15/15) - MPL (15)	GI.1/GII.4 (15/50) - MPL (15)	GI.1/GII.4 (50/50) - MPL (15)	GI.1/GII.4 (15/15)	GI.1/GII.4 (15/50)	GI.1/GII.4 (50/50)	GI.1/GII.4 (50/150)	GI.1/GII.4 (15/50) - Al(OH)3 (167)	GI.1/GII.4 (15/50) x2	GI.1/GII.4 (50/150) x2	GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Number of subjects analysed	30	29	28	29	30	31	30	32	28	30	24	28	29	30
Units: ratio
geometric mean (standard deviation)
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)	1 ( 1.13 )	0.9 ( 1.18 )	0.8 ( 1.5 )	1.2 ( 2.85 )	0.9 ( 1.26 )	1 ( 1.16 )	1 ( 1.36 )	1 ( 1.18 )	0.9 ( 1.28 )	0.9 ( 1.28 )	1 ( 1.58 )	19.5 ( 3.73 )	23.2 ( 3 )	22 ( 2.57 )
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)	17.3 ( 3.69 )	18.8 ( 3.46 )	25.8 ( 3.09 )	22.4 ( 4.38 )	22.4 ( 3.02 )	35.1 ( 3.88 )	18.1 ( 4.35 )	19 ( 3.67 )	36.5 ( 4.85 )	18.7 ( 3.31 )	13.5 ( 3.07 )	17 ( 3.63 )	19.7 ( 2.78 )	16.8 ( 2.74 )
D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)	6.9 ( 3.63 )	6.7 ( 3.71 )	9.3 ( 3.77 )	9 ( 4.32 )	7.1 ( 2.63 )	10.4 ( 3.79 )	6.4 ( 3.62 )	8.5 ( 3.9 )	10.7 ( 3 )	6.5 ( 2.96 )	5.2 ( 3.27 )	9.3 ( 3.57 )	8.3 ( 2.79 )	78 ( 3.52 )
D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)	4.4 ( 3.27 )	4.1 ( 4.46 )	7 ( 3.56 )	8 ( 4.65 )	5.1 ( 2.41 )	7.4 ( 3.36 )	5.3 ( 3.4 )	5.7 ( 3.41 )	7.8 ( 2.87 )	4.3 ( 2.58 )	4 ( 3.08 )	6.4 ( 4.07 )	6.3 ( 2.95 )	6.1 ( 2.85 )

No statistical analyses for this end point

Secondary: Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)

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End point title

Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)

End point description

Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by pan-Ig ELISA. D=Day Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. “n” in the category is the number of participants with data available at the given time-point.

End point type

Secondary

End point timeframe

Days 28, 56, 208 and 393

End point values	GI.1/GII.4 (15/15) - MPL (50)	GI.1/GII.4 (15/50) - MPL (50)	GI.1/GII.4 (50/50) - MPL (50)	GI.1/GII.4 (15/15) - MPL (15)	GI.1/GII.4 (15/50) - MPL (15)	GI.1/GII.4 (50/50) - MPL (15)	GI.1/GII.4 (15/15)	GI.1/GII.4 (15/50)	GI.1/GII.4 (50/50)	GI.1/GII.4 (50/150)	GI.1/GII.4 (15/50) - Al(OH)3 (167)	GI.1/GII.4 (15/50) x2	GI.1/GII.4 (50/150) x2	GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Number of subjects analysed	30	29	28	29	30	31	30	32	28	30	24	28	29	30
Units: ratio
geometric mean (standard deviation)
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)	0.9 ( 1.56 )	1 ( 1.14 )	1 ( 1.23 )	1 ( 1.21 )	0.9 ( 1.18 )	1 ( 1.13 )	0.9 ( 1.37 )	1.1 ( 1.57 )	1 ( 1.17 )	1 ( 1.58 )	1 ( 1.25 )	8.7 ( 3.25 )	9.7 ( 3.02 )	6.7 ( 3.11 )
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)	4.2 ( 3.11 )	7.2 ( 2.98 )	4 ( 2.66 )	4.1 ( 2.97 )	8.2 ( 2.72 )	6.9 ( 3.31 )	2.6 ( 2.6 )	8 ( 3.36 )	4 ( 3 )	7.2 ( 3.38 )	4.7 ( 1.97 )	6.8 ( 2.99 )	7.5 ( 2.74 )	5 ( 2.7 )
D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)	2.1 ( 2.45 )	3 ( 2.74 )	1.9 ( 1.96 )	2.6 ( 2.5 )	3.2 ( 2.36 )	2.7 ( 2.21 )	1.7 ( 2.17 )	4.1 ( 2.45 )	2 ( 2.06 )	3.1 ( 2.61 )	2.2 ( 1.92 )	3.9 ( 2.7 )	3.5 ( 2.24 )	2.5 ( 2.57 )
D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)	1.9 ( 2.77 )	2.6 ( 3.2 )	1.7 ( 2.41 )	2 ( 2.33 )	2.1 ( 2.34 )	1.9 ( 1.99 )	1.6 ( 2.46 )	2.4 ( 2.4 )	1.5 ( 2.27 )	1.7 ( 2.41 )	1.4 ( 2.27 )	2.5 ( 2.6 )	2.4 ( 2.22 )	1.7 ( 2.64 )

No statistical analyses for this end point

Secondary: Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)

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End point title

Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)

End point description

Percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 VLP and GII.4 VLP as measured by immunoglobulin A (IgA) enzyme-linked immunosorbent assay (ELISA) for all arms on day 28 and day 56. D=Day Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. “n” in the category is the number of participants with data available at the given time-point.

End point type

Secondary

End point timeframe

Baseline and Days 28 and 56

GI.1/GII.4 (15/15) - MPL (50)

GI.1/GII.4 (15/50) - MPL (50)

GI.1/GII.4 (50/50) - MPL (50)

GI.1/GII.4 (15/15) - MPL (15)

GI.1/GII.4 (15/50) - MPL (15)

GI.1/GII.4 (50/50) - MPL (15)

GI.1/GII.4 (15/15)

GI.1/GII.4 (15/50)

GI.1/GII.4 (50/50)

GI.1/GII.4 (50/150)

GI.1/GII.4 (15/50) - Al(OH)3 (167)

GI.1/GII.4 (15/50) x2

GI.1/GII.4 (50/150) x2

GI.1/GII.4 (15/50) - Al(OH)3 (167) x2

Number of subjects analysed

Units: percentage of participants

number (confidence interval 95%)

D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)

0 (0 to 11.6)

0 (0 to 11.9)

0 (0 to 11.2)

0 (0 to 11.6)

0 (0 to 11.2)

3.03 (0.1 to 17.2)

0 (0 to 10.9)

0 (0 to 12.3)

0 (0 to 11.6)

0 (0 to 12.8)

71.4 (51.3 to 86.8)

72.4 (52.8 to 87.3)

64.5 (45.4 to 80.8)

D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)

53.3 (34.3 to 71.7)

58.6 (38.9 to 76.5)

39.3 (21.5 to 59.4)

45.2 (27.3 to 64)

70 (50.6 to 85.3)

58.1 (39.1 to 75.5)

36.7 (19.9 to 56.1)

65.6 (46.8 to 81.4)

42.9 (24.5 to 62.8)

66.7 (47.2 to 82.7)

50 (29.9 to 70.1)

57.1 (37.2 to 75.5)

51.7 (32.5 to 70.6)

46.7 (28.3 to 65.7)

No statistical analyses for this end point

Secondary: Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)

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End point title

Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA) ^[10]

End point description

Percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 VLP and GII.4 VLP as measured by immunoglobulin A (IgA) enzyme-linked immunosorbent assay (ELISA) for selected arms on day 208 and day 393. D=Day Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. “n” in the category is the number of participants with data available at the given time-point.

End point type

Secondary

End point timeframe

Baseline and Days 208 and 393

Notes
[10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: No statistical analysis is reported for this endpoint.

End point values	GI.1/GII.4 (15/50) - MPL (15)	GI.1/GII.4 (15/50)
Number of subjects analysed	30	32
Units: percentage of participants
number (confidence interval 95%)
D208 (n=30,32)	30 (14.7 to 49.4)	25 (11.5 to 43.4)
D393 (n=30,31)	13.3 (3.8 to 30.7)	6.5 (0.8 to 21.4)

No statistical analyses for this end point

Secondary: Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)

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End point title

Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)

End point description

The percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for GI.1 virus-like particle (VLP) as measured by immunoglobulin A (IgA) enzyme-linked immunosorbent assay (ELISA) for all arms on day 28 and day 56. D=Day Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. “n” in the category is the number of participants with data available at the given time-point.

End point type

Secondary

End point timeframe

Baseline and Days 28 and 56

GI.1/GII.4 (15/15) - MPL (50)

GI.1/GII.4 (15/50) - MPL (50)

GI.1/GII.4 (50/50) - MPL (50)

GI.1/GII.4 (15/15) - MPL (15)

GI.1/GII.4 (15/50) - MPL (15)

GI.1/GII.4 (50/50) - MPL (15)

GI.1/GII.4 (15/15)

GI.1/GII.4 (15/50)

GI.1/GII.4 (50/50)

GI.1/GII.4 (50/150)

GI.1/GII.4 (15/50) - Al(OH)3 (167)

GI.1/GII.4 (15/50) x2

GI.1/GII.4 (50/150) x2

GI.1/GII.4 (15/50) - Al(OH)3 (167) x2

Number of subjects analysed

Units: percentage of participants

number (confidence interval 95%)

D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)

0 (0 to 11.6)

0 (0 to 11.9)

0 (0 to 12.8)

6.9 (0.8 to 22.8)

0 (0 to 11.6)

0 (0 to 11.2)

3.3 (0.1 to 17.2)

0 (0 to 10.9)

0 (0 to 12.8)

0 (0 to 11.6)

4.2 (0.1 to 21.1)

96.4 (81.7 to 99.9)

100 (88.1 to 100)

100 (88.4 to 100)

D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)

93.3 (77.9 to 99.2)

89.7 (72.6 to 97.8)

100 (87.7 to 100)

89.7 (72.6 to 97.8)

96.7 (82.8 to 99.9)

100 (88.8 to 100)

90 (73.5 to 97.9)

90.6 (75 to 98)

96.4 (81.7 to 99.9)

100 (88.4 to 100)

87.5 (67.6 to 97.3)

96.4 (81.7 to 99.9)

100 (88.1 to 100)

100 (88.4 to 100)

No statistical analyses for this end point

Secondary: Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)

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End point title

Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA) ^[11]

End point description

The percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for GI.1 virus-like particle (VLP) as measured by immunoglobulin A (IgA) enzyme-linked immunosorbent assay (ELISA) for selected arms on day 208 and day 393. D=Day Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. “n” in the category is the number of participants with data available at the given time-point.

End point type

Secondary

End point timeframe

Baseline and Days 208 and 393

Notes
[11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: No statistical analysis is reported for this endpoint.

End point values	GI.1/GII.4 (15/50) - MPL (15)	GI.1/GII.4 (15/50)
Number of subjects analysed	30	32
Units: percentage of participants
number (confidence interval 95%)
D208 (n=30,32)	80 (61.4 to 92.3)	71.9 (53.3 to 86.3)
D393 (n=30,31)	73.3 (54.1 to 87.7)	54.8 (36 to 72.7)

No statistical analyses for this end point

Secondary: Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)

Top of page

End point title

Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)

End point description

The percentage of participants with a 4-fold rise from or greater in serum anti-norovirus antibody titers for GII.4 virus-like particle (VLP) as measured by immunoglobulin A (IgA) enzyme-linked immunosorbent assay (ELISA) for all arms on day 28 and day 56. D=Day Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. “n” in the category is the number of participants with data available at the given time-point.

End point type

Secondary

End point timeframe

Baseline and Days 28 and 56

GI.1/GII.4 (15/15) - MPL (50)

GI.1/GII.4 (15/50) - MPL (50)

GI.1/GII.4 (50/50) - MPL (50)

GI.1/GII.4 (15/15) - MPL (15)

GI.1/GII.4 (15/50) - MPL (15)

GI.1/GII.4 (50/50) - MPL (15)

GI.1/GII.4 (15/15)

GI.1/GII.4 (15/50)

GI.1/GII.4 (50/50)

GI.1/GII.4 (50/150)

GI.1/GII.4 (15/50) - Al(OH)3 (167)

GI.1/GII.4 (15/50) x2

GI.1/GII.4 (50/150) x2

GI.1/GII.4 (15/50) - Al(OH)3 (167) x2

Number of subjects analysed

Units: percentage of participants

number (confidence interval 95%)

D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,

0 (0 to 11.6)

0 (0 to 11.9)

0 (0 to 12.8)

0 (0 to 11.7)

0 (0 to 11.9)

0 (0 to 11.2)

3.3 (0.1 to 17.2)

3.1 (0.1 to 16.2)

0 (0 to 12.8)

3.3 (0.1 to 17.2)

0 (0 to 14.2)

75 (55.1 to 89.3)

72.4 (52.8 to 87.3)

63.3 (43.9 to 80.1)

D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,

53.3 (34.3 to 71.7)

65.5 (45.7 to 82.1)

39.3 (21.5 to 59.4)

51.7 (32.5 to 70.6)

73.3 (54.1 to 87.7)

58.1 (39.1 to 75.5)

36.7 (19.9 to 56.1)

68.8 (50 to 83.9)

46.4 (27.5 to 66.1)

66.7 (47.2 to 82.7)

54.2 (32.8 to 74.4)

60.7 (40.6 to 78.5)

51.7 (32.5 to 70.6)

46.7 (28.3 to 65.7)

No statistical analyses for this end point

Secondary: Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)

Top of page

End point title

Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA) ^[12]

End point description

The percentage of participants with a 4-fold rise from or greater in serum anti-norovirus antibody titers for GII.4 virus-like particle (VLP) as measured by immunoglobulin A (IgA) enzyme-linked immunosorbent assay (ELISA) for selected arms on day 208 and day 393. D=Day Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. “n” in the category is the number of participants with data available at the given time-point.

End point type

Secondary

End point timeframe

Baseline and Days 208 and 393

Notes
[12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: No statistical analysis is reported for this endpoint.

End point values	GI.1/GII.4 (15/50) - MPL (15)	GI.1/GII.4 (15/50)
Number of subjects analysed	30	32
Units: percentage of participants
number (confidence interval 95%)
D208 (n=30,32)	36.7 (19.9 to 56.1)	34.4 (18.6 to 53.2)
D393 (n=30,31)	23.3 (9.9 to 42.3)	16.1 (5.5 to 33.7)

No statistical analyses for this end point

Secondary: Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)

Top of page

End point title

Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)

End point description

Geometric mean titer (GMT) of anti-norovirus GI.1 VLP antibody titers as measured by IgA ELISA for all arms on day 28 and day 56. D=Day Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. “n” in the category is the number of participants with data available at the given time-point.

End point type

Secondary

End point timeframe

Day 1 (Baseline) and Days 28 and 56

End point values	GI.1/GII.4 (15/15) - MPL (50)	GI.1/GII.4 (15/50) - MPL (50)	GI.1/GII.4 (50/50) - MPL (50)	GI.1/GII.4 (15/15) - MPL (15)	GI.1/GII.4 (15/50) - MPL (15)	GI.1/GII.4 (50/50) - MPL (15)	GI.1/GII.4 (15/15)	GI.1/GII.4 (15/50)	GI.1/GII.4 (50/50)	GI.1/GII.4 (50/150)	GI.1/GII.4 (15/50) - Al(OH)3 (167)	GI.1/GII.4 (15/50) x2	GI.1/GII.4 (50/150) x2	GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Number of subjects analysed	30	30	30	31	30	31	30	32	29	30	29	28	29	31
Units: titer
geometric mean (standard deviation)
D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)	52.9 ( 4.86 )	37.4 ( 3.59 )	42.1 ( 3.63 )	32.1 ( 5.26 )	30.1 ( 3.26 )	44.5 ( 6.06 )	53.6 ( 5.76 )	60.1 ( 6.45 )	36.8 ( 5.3 )	58.5 ( 4.08 )	47 ( 4.91 )	73.3 ( 5.24 )	40.8 ( 4.25 )	41.5 ( 3.74 )
D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)	48.9 ( 4.99 )	34.6 ( 3.38 )	41.2 ( 3.85 )	41 ( 4.38 )	29.4 ( 3.31 )	46.2 ( 6.22 )	54.4 ( 5.67 )	59.8 ( 6.23 )	37.8 ( 5.2 )	56.3 ( 3.95 )	57 ( 5.31 )	1649.9 ( 4.88 )	2148.2 ( 2.98 )	1703.2 ( 2.62 )
D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)	1358.4 ( 4.02 )	996.2 ( 5.02 )	2223.3 ( 2.91 )	1068.7 ( 5.39 )	1368.6 ( 3.99 )	1849.8 ( 3.35 )	1594.9 ( 4.87 )	1435.5 ( 7.02 )	2074.3 ( 4.4 )	1510.6 ( 4.45 )	1131.2 ( 4.28 )	810.7 ( 5.58 )	922.6 ( 3.73 )	848.2 ( 3.63 )

No statistical analyses for this end point

Secondary: Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)

Top of page

End point title

Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA) ^[13]

End point description

Geometric mean titer (GMT) of anti-norovirus GI.1 VLP antibody titers as measured by IgA ELISA for selected arms on day 208 and day 393. D=Day Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. “n” in the category is the number of participants with data available at the given time-point.

End point type

Secondary

End point timeframe

Day 1 (Baseline) and Days 208 and 393

Notes
[13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: No statistical analysis is reported for this endpoint.

End point values	GI.1/GII.4 (15/50) - MPL (15)	GI.1/GII.4 (15/50)
Number of subjects analysed	30	32
Units: titer
geometric mean (standard deviation)
D208 (n=30,32)	302.5 ( 4.1 )	512.4 ( 5.85 )
D393 (n=30,31)	224 ( 2.73 )	340.1 ( 3.91 )

No statistical analyses for this end point

Secondary: Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)

Top of page

End point title

Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)

End point description

Geometric mean titer (GMT) of anti-norovirus GII.4 VLP antibody titers as measured by IgA ELISA for all arms on day 28 and day 56. D=Day Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. “n” in the category is the number of participants with data available at the given time-point.

End point type

Secondary

End point timeframe

Day 1 (Baseline) and Days 28 and 56

End point values	GI.1/GII.4 (15/15) - MPL (50)	GI.1/GII.4 (15/50) - MPL (50)	GI.1/GII.4 (50/50) - MPL (50)	GI.1/GII.4 (15/15) - MPL (15)	GI.1/GII.4 (15/50) - MPL (15)	GI.1/GII.4 (50/50) - MPL (15)	GI.1/GII.4 (15/15)	GI.1/GII.4 (15/50)	GI.1/GII.4 (50/50)	GI.1/GII.4 (50/150)	GI.1/GII.4 (15/50) - Al(OH)3 (167)	GI.1/GII.4 (15/50) x2	GI.1/GII.4 (50/150) x2	GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Number of subjects analysed	30	30	30	31	30	31	30	32	29	30	29	28	29	31
Units: titer
geometric mean (standard deviation)
D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)	83.4 ( 6.63 )	113.6 ( 4.43 )	145.5 ( 4.72 )	119.5 ( 4.47 )	72.8 ( 4.64 )	114.6 ( 4.56 )	100.2 ( 4.47 )	133 ( 4.77 )	114.3 ( 4.65 )	158.5 ( 3.41 )	201.7 ( 3.3 )	105.9 ( 4.08 )	121.9 ( 4.16 )	174.5 ( 4.13 )
D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)	77.8 ( 6.49 )	110 ( 4.31 )	151.2 ( 4.7 )	125.3 ( 4.34 )	73.8 ( 4.42 )	116.3 ( 4.49 )	106.3 ( 4.05 )	139.2 ( 5.48 )	106.3 ( 4.71 )	164.8 ( 3.16 )	218.8 ( 3.07 )	953.5 ( 2.83 )	948.2 ( 2.52 )	1118 ( 2.91 )
D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)	495.7 ( 3.3 )	840.8 ( 2.87 )	583.7 ( 2.34 )	467.9 ( 2.79 )	803.3 ( 3.24 )	714.2 ( 2.44 )	336.7 ( 3.74 )	1088.9 ( 3.72 )	513.9 ( 3.82 )	1117.7 ( 3.03 )	1027.3 ( 2.36 )	578.8 ( 3.11 )	552.2 ( 2.6 )	691.2 ( 3.12 )

No statistical analyses for this end point

Secondary: Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)

Top of page

End point title

Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA) ^[14]

End point description

Geometric mean titer (GMT) of anti-norovirus GII.4 VLP antibody titers as measured by IgA ELISA for selected arms on day 208 and day 393. D=Day Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. “n” in the category is the number of participants with data available at the given time-point.

End point type

Secondary

End point timeframe

Days 208 and 393

Notes
[14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: No statistical analysis is reported for this endpoint.

End point values	GI.1/GII.4 (15/50) - MPL (15)	GI.1/GII.4 (15/50)
Number of subjects analysed	30	32
Units: titer
geometric mean (standard deviation)
D208 (n=30,32)	251.8 ( 3.94 )	427.9 ( 3.95 )
D393 (n=30,31)	139.7 ( 4.07 )	273.4 ( 3.59 )

No statistical analyses for this end point

Secondary: Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)

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End point title

Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)

End point description

Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by IgA ELISA for all arms on day 28 and day 56. D=Day Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. “n” in the category is the number of participants with data available at the given time-point.

End point type

Secondary

End point timeframe

Days 28 and 56

End point values	GI.1/GII.4 (15/15) - MPL (50)	GI.1/GII.4 (15/50) - MPL (50)	GI.1/GII.4 (50/50) - MPL (50)	GI.1/GII.4 (15/15) - MPL (15)	GI.1/GII.4 (15/50) - MPL (15)	GI.1/GII.4 (50/50) - MPL (15)	GI.1/GII.4 (15/15)	GI.1/GII.4 (15/50)	GI.1/GII.4 (50/50)	GI.1/GII.4 (50/150)	GI.1/GII.4 (15/50) - Al(OH)3 (167)	GI.1/GII.4 (15/50) x2	GI.1/GII.4 (50/150) x2	GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Number of subjects analysed	30	29	28	29	30	31	30	32	28	30	24	28	29	30
Units: ratio
geometric mean (standard deviation)
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)	0.9 ( 1.52 )	0.9 ( 1.49 )	1 ( 1.23 )	1.3 ( 2.65 )	1 ( 1.23 )	1 ( 1.14 )	1 ( 1.44 )	1 ( 1.1 )	1 ( 1.13 )	1 ( 1.46 )	1.2 ( 1.86 )	22.5 ( 2.95 )	52.7 ( 2.79 )	42.3 ( 2.39 )
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)	25.7 ( 4.46 )	28 ( 4.4 )	49.2 ( 2.81 )	34.2 ( 5.55 )	45.4 ( 3.47 )	41.5 ( 3.5 )	29.8 ( 4.63 )	23.9 ( 4.13 )	52.1 ( 3.61 )	25.8 ( 3.15 )	20.8 ( 2.77 )	11.1 ( 2.19 )	22.6 ( 2.29 )	21.1 ( 2.81 )

No statistical analyses for this end point

Secondary: Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)

Top of page

End point title

Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA) ^[15]

End point description

Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by IgA ELISA for selected arms on day 208 and day 393. D=Day Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. “n” in the category is the number of participants with data available at the given time-point.

End point type

Secondary

End point timeframe

Days 208 and 393

Notes
[15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: No statistical analysis is reported for this endpoint.

End point values	GI.1/GII.4 (15/50) - MPL (15)	GI.1/GII.4 (15/50)
Number of subjects analysed	30	32
Units: ratio
geometric mean (standard deviation)
D208 (n=30,32)	10 ( 2.89 )	8.5 ( 3.77 )
D393 (n=30,31)	7.4 ( 2.41 )	5.2 ( 3.34 )

No statistical analyses for this end point

Secondary: Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)

Top of page

End point title

Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)

End point description

Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by IgA ELISA for all arms on day 28 and day 56. D=Day Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. “n” in the category is the number of participants with data available at the given time-point.

End point type

Secondary

End point timeframe

Days 28 and 56

End point values	GI.1/GII.4 (15/15) - MPL (50)	GI.1/GII.4 (15/50) - MPL (50)	GI.1/GII.4 (50/50) - MPL (50)	GI.1/GII.4 (15/15) - MPL (15)	GI.1/GII.4 (15/50) - MPL (15)	GI.1/GII.4 (50/50) - MPL (15)	GI.1/GII.4 (15/15)	GI.1/GII.4 (15/50)	GI.1/GII.4 (50/50)	GI.1/GII.4 (50/150)	GI.1/GII.4 (15/50) - Al(OH)3 (167)	GI.1/GII.4 (15/50) x2	GI.1/GII.4 (50/150) x2	GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Number of subjects analysed	30	29	28	29	30	31	30	32	28	30	24	28	29	30
Units: ratio
geometric mean (standard deviation)
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)	0.9 ( 1.33 )	1 ( 1.42 )	1 ( 1.13 )	1.1 ( 1.27 )	1 ( 1.14 )	1 ( 1.09 )	1.1 ( 1.44 )	1 ( 1.6 )	1 ( 1.1 )	1 ( 1.36 )	1 ( 1.22 )	9 ( 2.85 )	7.8 ( 2.89 )	6.3 ( 3.11 )
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)	5.9 ( 4.37 )	7.7 ( 3.92 )	3.6 ( 2.45 )	4.2 ( 2.54 )	11 ( 3.48 )	6.2 ( 3.36 )	3.4 ( 2.7 )	8.2 ( 3.36 )	4 ( 3.14 )	7.1 ( 2.81 )	4.9 ( 2.35 )	5.5 ( 4.74 )	4.5 ( 2.53 )	3.9 ( 2.41 )

No statistical analyses for this end point

Secondary: Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)

Top of page

End point title

Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA) ^[16]

End point description

Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by IgA ELISA for selected arms on day 208 and day 393. D=Day Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. “n” in the category is the number of participants with data available at the given time-point.

End point type

Secondary

End point timeframe

Days 208 and 393

Notes
[16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: No statistical analysis is reported for this endpoint.

End point values	GI.1/GII.4 (15/50) - MPL (15)	GI.1/GII.4 (15/50)
Number of subjects analysed	30	32
Units: ratio
geometric mean (standard deviation)
D208 (n=30,32)	3.5 ( 2.67 )	3.2 ( 2.44 )
D393 (n=30,31)	1.9 ( 2.47 )	1.9 ( 2.26 )

No statistical analyses for this end point

Secondary: Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)

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End point title

Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)

End point description

Percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 VLP and GII.4 VLP as measured by histoblood group antigen (HBGA) binding assay. D=Day Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. “n” in the category is the number of participants with data available at the given time-point.

End point type

Secondary

End point timeframe

Baseline and Days 28, 56, 208 and 393

GI.1/GII.4 (15/15) - MPL (50)

GI.1/GII.4 (15/50) - MPL (50)

GI.1/GII.4 (50/50) - MPL (50)

GI.1/GII.4 (15/15) - MPL (15)

GI.1/GII.4 (15/50) - MPL (15)

GI.1/GII.4 (50/50) - MPL (15)

GI.1/GII.4 (15/15)

GI.1/GII.4 (15/50)

GI.1/GII.4 (50/50)

GI.1/GII.4 (50/150)

GI.1/GII.4 (15/50) - Al(OH)3 (167)

GI.1/GII.4 (15/50) x2

GI.1/GII.4 (50/150) x2

GI.1/GII.4 (15/50) - Al(OH)3 (167) x2

Number of subjects analysed

Units: percentage of participants

number (confidence interval 95%)

D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)

0 (0 to 11.6)

0 (0 to 11.9)

0 (0 to 11.2)

0 (0 to 11.6)

0 (0 to 11.2)

0 (0 to 11.6)

0 (0 to 10.9)

0 (0 to 12.3)

0 (0 to 11.6)

0 (0 to 12.8)

67.9 (47.6 to 84.1)

62.1 (42.3 to 79.3)

67.7 (48.6 to 83.3)

D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)

33.3 (17.3 to 52.8)

55.2 (35.7 to 73.6)

32.1 (15.9 to 52.4)

35.5 (19.2 to 54.6)

66.7 (47.2 to 82.7)

51.6 (33.1 to 69.8)

26.7 (12.3 to 45.9)

59.4 (40.6 to 76.3)

28.6 (13.2 to 48.7)

60 (40.6 to 77.3)

53.8 (33.4 to 73.4)

75 (55.1 to 89.3)

58.6 (38.9 to 76.5)

56.7 (37.4 to 74.5)

D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,28)

10 (2.1 to 26.5)

20.7 (8 to 39.7)

16.7 (5.6 to 34.7)

6.5 (0.8 to 21.4)

13.3 (3.8 to 30.7)

20 (7.7 to 38.6)

31.3 (16.1 to 50)

20.7 (8 to 39.7)

16.7 (5.6 to 34.7)

7.4 (0.9 to 24.3)

42.9 (24.5 to 62.8)

34.5 (17.9 to 54.3)

21.4 (8.3 to 41)

D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,28)

3.4 (0.1 to 17.8)

13.8 (3.9 to 31.7)

6.7 (0.8 to 22.1)

3.2 (0.1 to 16.7)

6.7 (0.8 to 22.1)

3.4 (0.1 to 17.8)

6.9 (0.8 to 22.8)

9.4 (2 to 25)

3.4 (0.1 to 17.8)

3.3 (0.1 to 17.2)

3.7 (0.1 to 19)

7.1 (0.9 to 23.5)

10.3 (2.2 to 27.4)

7.1 (0.9 to 23.5)

No statistical analyses for this end point

Secondary: Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)

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End point title

Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)

End point description

The percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for GI.1 virus-like particle (VLP) as measured by HBGA binding assay. D=Day Per-Protocol Set included all participants who received both doses of study drug and who had no major protocol violations. “n” in the category is the number of participants with data available at the given time-point.

End point type

Secondary

End point timeframe

Baseline and Days 28, 56, 208 and 393

GI.1/GII.4 (15/15) - MPL (50)

GI.1/GII.4 (15/50) - MPL (50)

GI.1/GII.4 (50/50) - MPL (50)

GI.1/GII.4 (15/15) - MPL (15)

GI.1/GII.4 (15/50) - MPL (15)

GI.1/GII.4 (50/50) - MPL (15)

GI.1/GII.4 (15/15)

GI.1/GII.4 (15/50)

GI.1/GII.4 (50/50)

GI.1/GII.4 (50/150)

GI.1/GII.4 (15/50) - Al(OH)3 (167)

GI.1/GII.4 (15/50) x2

GI.1/GII.4 (50/150) x2

GI.1/GII.4 (15/50) - Al(OH)3 (167) x2

Number of subjects analysed

Units: percentage of participants

number (confidence interval 95%)

D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)

0 (0 to 11.6)

0 (0 to 11.9)

0 (0 to 12.8)

0 (0 to 11.9)

0 (0 to 11.6)

0 (0 to 11.2)

0 (0 to 11.6)

0 (0 to 10.9)

0 (0 to 12.8)

0 (0 to 11.6)

0 (0 to 14.2)

82.1 (63.1 to 93.9)

96.6 (82.2 to 99.9)

93.3 (77.9 to 99.2)

D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)

80 (61.4 to 92.3)

79.3 (60.3 to 92)

85.7 (67.3 to 96)

82.8 (64.2 to 94.2)

86.7 (69.3 to 96.2)

87.1 (70.2 to 96.4)

76.7 (57.7 to 90.1)

78.1 (60 to 90.7)

85.7 (67.3 to 96)

90 (73.5 to 97.9)

70.8 (48.9 to 87.4)

100 (87.7 to 100)

96.6 (82.2 to 99.9)

93.3 (77.9 to 99.2)

D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)

53.3 (34.3 to 71.7)

65.5 (45.7 to 82.1)

67.9 (47.6 to 84.1)

58.6 (38.9 to 76.5)

43.3 (25.5 to 62.6)

70 (50.6 to 85.3)

60 (40.6 to 77.3)

78.1 (60 to 90.7)

82.1 (63.1 to 93.9)

56.7 (37.4 to 74.5)

33.3 (15.6 to 55.3)

85.7 (67.3 to 96)

93.1 (77.2 to 99.2)

77.8 (57.7 to 91.4)

D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)

31 (15.3 to 50.8)

32.1 (15.9 to 52.4)

50 (30.6 to 69.4)

37.9 (20.7 to 57.7)

23.3 (9.9 to 42.3)

37.9 (20.7 to 57.7)

44.8 (26.4 to 64.3)

53.1 (34.7 to 70.9)

53.6 (33.9 to 72.5)

26.7 (12.3 to 45.9)

29.2 (12.6 to 51.1)

50 (30.6 to 69.4)

51.7 (32.5 to 70.6)

46.4 (27.5 to 66.1)

No statistical analyses for this end point

Secondary: Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)

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End point title

Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)

End point description

The percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for GII.4 virus-like particle (VLP) as measured by HBGA binding assay. D=Day Per-Protocol Set included all participants who received both doses of study drug and who had no major protocol violations. “n” in the category is the number of participants with data available at the given time-point.

End point type

Secondary

End point timeframe

Baseline and Days 28, 56, 208 and 393

GI.1/GII.4 (15/15) - MPL (50)

GI.1/GII.4 (15/50) - MPL (50)

GI.1/GII.4 (50/50) - MPL (50)

GI.1/GII.4 (15/15) - MPL (15)

GI.1/GII.4 (15/50) - MPL (15)

GI.1/GII.4 (50/50) - MPL (15)

GI.1/GII.4 (15/15)

GI.1/GII.4 (15/50)

GI.1/GII.4 (50/50)

GI.1/GII.4 (50/150)

GI.1/GII.4 (15/50) - Al(OH)3 (167)

GI.1/GII.4 (15/50) x2

GI.1/GII.4 (50/150) x2

GI.1/GII.4 (15/50) - Al(OH)3 (167) x2

Number of subjects analysed

Units: percentage of participants

number (confidence interval 95%)

D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)

3.3 (0.1 to 17.2)

0 (0 to 11.9)

3.7 (0.1 to 19)

0 (0 to 11.9)

3.3 (0.1 to 17.2)

0 (0 to 11.2)

0 (0 to 11.6)

3.1 (0.1 to 16.2)

3.7 (0.1 to 19)

3.3 (0.1 to 17.2)

0 (0 to 14.2)

82.1 (63.1 to 93.9)

65.5 (45.7 to 82.1)

70 (50.6 to 85.3)

D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)

46.7 (28.3 to 65.7)

72.4 (52.8 to 87.3)

39.3 (21.5 to 59.4)

41.4 (23.5 to 61.1)

80 (61.4 to 92.3)

61.3 (42.2 to 78.2)

26.7 (12.3 to 45.9)

71.9 (53.3 to 86.3)

35.7 (18.6 to 55.9)

63.3 (43.9 to 80.1)

66.7 (44.7 to 84.4)

75 (55.1 to 89.3)

58.6 (38.9 to 76.5)

60 (40.6 to 77.3)

D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)

26.7 (12.3 to 45.9)

31 (15.3 to 50.8)

17.9 (6.1 to 36.9)

20.7 (8 to 39.7)

43.3 (25.5 to 62.6)

20 (7.7 to 38.6)

43.8 (26.4 to 62.3)

21.4 (8.3 to 41)

33.3 (17.3 to 52.8)

25 (9.8 to 46.7)

50 (30.6 to 69.4)

37.9 (20.7 to 57.7)

22.2 (8.6 to 42.3)

D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)

13.8 (3.9 to 31.7)

21.4 (8.3 to 41)

3.6 (0.1 to 18.3)

17.2 (5.8 to 35.8)

23.3 (9.9 to 42.3)

3.4 (0.1 to 17.8)

10.3 (2.2 to 27.4)

12.5 (3.5 to 29)

10.7 (2.3 to 28.2)

16.7 (5.6 to 34.7)

4.2 (0.1 to 21.1)

21.4 (8.3 to 41)

24.1 (10.3 to 43.5)

10.7 (2.3 to 28.2)

No statistical analyses for this end point

Secondary: Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)

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End point title

Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)

End point description

Blocking titers 50 (BT50) of anti-norovirus GI.1 VLP antibody titers as measured by HBGA binding assay. D=Day Full Analysis Set included all participants who received at least one dose of trial vaccine. “n” in the category is the number of participants with data available at the given time-point.

End point type

Secondary

End point timeframe

Baseline (Day 1) and Days 28, 56, 208 and 393

End point values	GI.1/GII.4 (15/15) - MPL (50)	GI.1/GII.4 (15/50) - MPL (50)	GI.1/GII.4 (50/50) - MPL (50)	GI.1/GII.4 (15/15) - MPL (15)	GI.1/GII.4 (15/50) - MPL (15)	GI.1/GII.4 (50/50) - MPL (15)	GI.1/GII.4 (15/15)	GI.1/GII.4 (15/50)	GI.1/GII.4 (50/50)	GI.1/GII.4 (50/150)	GI.1/GII.4 (15/50) - Al(OH)3 (167)	GI.1/GII.4 (15/50) x2	GI.1/GII.4 (50/150) x2	GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Number of subjects analysed	30	30	30	31	30	31	30	32	29	30	29	28	29	31
Units: titer
geometric mean (standard deviation)
D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)	24.8 ( 2.75 )	18.7 ( 1.85 )	26 ( 2.73 )	26.8 ( 3.35 )	19.1 ( 1.68 )	24.8 ( 2.31 )	30.5 ( 3.04 )	24.5 ( 2.59 )	23.8 ( 2.46 )	23.2 ( 2.19 )	26.3 ( 2.68 )	23.1 ( 2.25 )	22.3 ( 2.26 )	20.6 ( 2.04 )
D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)	25 ( 2.6 )	18.6 ( 1.86 )	23.8 ( 2.44 )	26.7 ( 3.19 )	18.6 ( 1.7 )	23 ( 2.24 )	27.3 ( 2.46 )	25.1 ( 2.52 )	25.5 ( 2.52 )	24.8 ( 2.37 )	28.5 ( 2.66 )	347.6 ( 4.62 )	385.9 ( 3.64 )	391.1 ( 3.56 )
D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)	280.5 ( 3.94 )	236.3 ( 4.61 )	403.3 ( 3.74 )	286.9 ( 5.01 )	22.86 ( 3.94 )	356.4 ( 3.74 )	400.1 ( 3.33 )	412.9 ( 4.78 )	510 ( 4.36 )	247.2 ( 3.43 )	271.3 ( 5 )	398.6 ( 2.7 )	463.5 ( 2.32 )	355.8 ( 2.58 )
D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)	130 ( 3.38 )	98.2 ( 3.46 )	159 ( 3.23 )	136.4 ( 3.67 )	80.1 ( 3.49 )	139.3 ( 2.68 )	159.8 ( 2.73 )	202.1 ( 3.34 )	208.6 ( 3.28 )	114.5 ( 2.89 )	107.9 ( 3.28 )	196.4 ( 2.86 )	219.2 ( 2.29 )	182 ( 2.4 )
D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)	67.8 ( 3.78 )	51.3 ( 3.23 )	88.1 ( 6.54 )	74.8 ( 4.26 )	44 ( 3.39 )	71.9 ( 3.4 )	91.5 ( 3.14 )	107.5 ( 3.97 )	99.6 ( 4.09 )	55 ( 3.22 )	66.1 ( 3.86 )	103.4 ( 3.95 )	113.6 ( 3.3 )	81 ( 2.85 )

No statistical analyses for this end point

Secondary: Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)

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End point title

Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)

End point description

Blocking titers 50 (BT50) of anti-norovirus GII.4 VLP antibody titers as measured by HBGA binding assay. D=Day Full Analysis Set included all participants who received at least one dose of trial vaccine. “n” in the category is the number of participants with data available at the given time-point.

End point type

Secondary

End point timeframe

Day 1 (Baseline) and Days 28, 56, 208 and 393

End point values	GI.1/GII.4 (15/15) - MPL (50)	GI.1/GII.4 (15/50) - MPL (50)	GI.1/GII.4 (50/50) - MPL (50)	GI.1/GII.4 (15/15) - MPL (15)	GI.1/GII.4 (15/50) - MPL (15)	GI.1/GII.4 (50/50) - MPL (15)	GI.1/GII.4 (15/15)	GI.1/GII.4 (15/50)	GI.1/GII.4 (50/50)	GI.1/GII.4 (50/150)	GI.1/GII.4 (15/50) - Al(OH)3 (167)	GI.1/GII.4 (15/50) x2	GI.1/GII.4 (50/150) x2	GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Number of subjects analysed	30	30	30	31	30	31	30	32	29	30	29	28	29	31
Units: titer
geometric mean (standard deviation)
D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)	66 ( 4.85 )	80.1 ( 3.44 )	115.3 ( 4.24 )	91.4 ( 4.15 )	60.9 ( 3.84 )	96.6 ( 4.03 )	80.7 ( 4.48 )	89.8 ( 4.41 )	96.2 ( 3.93 )	102.3 ( 3.39 )	121.9 ( 3.47 )	56.1 ( 3.48 )	92 ( 3.96 )	117.8 ( 3.91 )
D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)	69.3 ( 4.56 )	75.7 ( 3.63 )	124.9 ( 3.98 )	87.9 ( 3.75 )	67.7 ( 3.76 )	94.5 ( 4.3 )	74.6 ( 4.17 )	98.1 ( 5.11 )	92.9 ( 3.87 )	123.3 ( 3.25 )	117.6 ( 3.62 )	552.6 ( 3.65 )	688.4 ( 3.16 )	904.4 ( 2.67 )
D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)	336.9 ( 3.4 )	686.3 ( 3.47 )	429 ( 2.4 )	317.8 ( 2.94 )	675.7 ( 3.21 )	632.1 ( 2.11 )	189.2 ( 4.63 )	842.8 ( 3.23 )	360.1 ( 3.85 )	862.8 ( 3.12 )	778 ( 2.57 )	426.5 ( 3.46 )	596.3 ( 2.86 )	604.4 ( 2.91 )
D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)	186.7 ( 3.19 )	241.5 ( 3.24 )	244.6 ( 2.78 )	206.3 ( 2.84 )	229.9 ( 3.6 )	259.7 ( 2.66 )	142.5 ( 4.09 )	346.8 ( 2.92 )	201 ( 3.49 )	340.6 ( 2.6 )	324.6 ( 3.07 )	277.5 ( 2.53 )	350.9 ( 2.36 )	295.3 ( 3.07 )
D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,28)	120.5 ( 4.21 )	180.2 ( 3.95 )	123.5 ( 3.87 )	133.2 ( 3.81 )	104.7 ( 4.01 )	134.4 ( 3.74 )	109.3 ( 4.44 )	182.9 ( 3.6 )	121.9 ( 3.88 )	179.7 ( 2.53 )	209 ( 3.38 )	126.2 ( 3.56 )	171.2 ( 3.61 )	192.9 ( 3.52 )

No statistical analyses for this end point

Secondary: Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)

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End point title

Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)

End point description

Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by HBGA binding assay. D=Day Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. “n” in the category is the number of participants with data available at the given time-point.

End point type

Secondary

End point timeframe

Days 28, 56, 208 and 393

End point values	GI.1/GII.4 (15/15) - MPL (50)	GI.1/GII.4 (15/50) - MPL (50)	GI.1/GII.4 (50/50) - MPL (50)	GI.1/GII.4 (15/15) - MPL (15)	GI.1/GII.4 (15/50) - MPL (15)	GI.1/GII.4 (50/50) - MPL (15)	GI.1/GII.4 (15/15)	GI.1/GII.4 (15/50)	GI.1/GII.4 (50/50)	GI.1/GII.4 (50/150)	GI.1/GII.4 (15/50) - Al(OH)3 (167)	GI.1/GII.4 (15/50) x2	GI.1/GII.4 (50/150) x2	GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Number of subjects analysed	30	29	28	29	30	31	30	32	28	30	24	28	29	30
Units: titer
geometric mean (standard deviation)
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)	1 ( 1.3 )	1 ( 1.08 )	0.9 ( 1.3 )	1 ( 1.21 )	1 ( 1.37 )	0.9 ( 1.26 )	0.9 ( 1.59 )	1 ( 1.22 )	1.1 ( 1.37 )	1.1 ( 1.28 )	1 ( 1.31 )	15 ( 3.8 )	17.3 ( 3.02 )	19.3 ( 3.33 )
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)	11.3 ( 4.25 )	13.2 ( 4.31 )	14.9 ( 3.54 )	10 ( 4.07 )	12 ( 3.36 )	14.3 ( 2.98 )	13.1 ( 3.96 )	16.9 ( 4.6 )	21.1 ( 3.72 )	10.7 ( 2.53 )	9.7 ( 4.29 )	17.2 ( 2.36 )	20.8 ( 2.2 )	17.9 ( 2.68 )
D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)	5.2 ( 3.41 )	5.5 ( 3.18 )	6 ( 2.97 )	4.8 ( 2.91 )	4.2 ( 2.94 )	5.9 ( 2 )	5.2 ( 2.69 )	8.2 ( 3.14 )	8.6 ( 2.63 )	4.9 ( 2.24 )	3.7 ( 2.95 )	8.5 ( 2.52 )	9.8 ( 2.18 )	7.9 ( 2.21 )
D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)	2.7 ( 3.29 )	2.7 ( 2.71 )	3.3 ( 2.87 )	2.6 ( 2.97 )	2.3 ( 2.65 )	3 ( 2.35 )	2.9 ( 2.61 )	4.4 ( 3.3 )	4 ( 3.1 )	2.4 ( 2.35 )	2.4 ( 2.73 )	4.5 ( 3.29 )	5.1 ( 2.81 )	3.8 ( 2.6 )

No statistical analyses for this end point

Secondary: Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)

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End point title

Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)

End point description

Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by the HBGA binding assay. D=Day Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. “n” in the category is the number of participants with data available at the given time-point.

End point type

Secondary

End point timeframe

Days 28 and 56

End point values	GI.1/GII.4 (15/15) - MPL (50)	GI.1/GII.4 (15/50) - MPL (50)	GI.1/GII.4 (50/50) - MPL (50)	GI.1/GII.4 (15/15) - MPL (15)	GI.1/GII.4 (15/50) - MPL (15)	GI.1/GII.4 (50/50) - MPL (15)	GI.1/GII.4 (15/15)	GI.1/GII.4 (15/50)	GI.1/GII.4 (50/50)	GI.1/GII.4 (50/150)	GI.1/GII.4 (15/50) - Al(OH)3 (167)	GI.1/GII.4 (15/50) x2	GI.1/GII.4 (50/150) x2	GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Number of subjects analysed	30	29	28	29	30	31	30	32	28	30	24	28	29	30
Units: titer
geometric mean (standard deviation)
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)	1.1 ( 1.68 )	0.9 ( 1.59 )	1 ( 1.47 )	1 ( 1.73 )	1.1 ( 1.62 )	1 ( 1.38 )	0.9 ( 1.29 )	1.1 ( 1.89 )	1 ( 1.59 )	1.2 ( 2.45 )	1 ( 1.46 )	9.8 ( 3.48 )	7.5 ( 3.13 )	7 ( 2.96 )
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)	5.1 ( 4.42 )	8.9 ( 3.31 )	3.6 ( 2.71 )	3.7 ( 3.43 )	11.1 ( 3.32 )	6.5 ( 3.33 )	2.3 ( 2.95 )	9.4 ( 3.95 )	3.5 ( 3.61 )	8.4 ( 3.59 )	6 ( 2.24 )	7.6 ( 3.19 )	6.5 ( 2.94 )	4.8 ( 2.46 )
D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)	2.8 ( 3.1 )	3.1 ( 2.51 )	2 ( 2.42 )	2.4 ( 2.58 )	3.8 ( 2.56 )	2.5 ( 1.99 )	1.8 ( 2.27 )	3.9 ( 3.03 )	2 ( 2.3 )	3.3 ( 2.66 )	2.5 ( 1.73 )	4.9 ( 2.72 )	3.8 ( 2.81 )	2.5 ( 2.35 )
D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)	1.7 ( 3.14 )	2.3 ( 2.42 )	1 ( 2.43 )	1.5 ( 2.56 )	1.7 ( 2.32 )	1.4 ( 1.82 )	1.3 ( 2.25 )	2 ( 2.59 )	1.3 ( 2.28 )	1.8 ( 2.11 )	1.6 ( 1.9 )	2.2 ( 2.7 )	1.9 ( 2.62 )	1.4 ( 2.23 )

No statistical analyses for this end point

Secondary: GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)

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End point title

GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)

End point description

GMFR of anti-norovirus GII.4 Cincinnati antibody titers as measured by HBGA binding assay. D=Day Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. “n” in the category is the number of participants with data available at the given time-point.

End point type

Secondary

End point timeframe

Days 28 and 56

End point values	GI.1/GII.4 (15/15) - MPL (50)	GI.1/GII.4 (15/50) - MPL (50)	GI.1/GII.4 (50/50) - MPL (50)	GI.1/GII.4 (15/15) - MPL (15)	GI.1/GII.4 (15/50) - MPL (15)	GI.1/GII.4 (50/50) - MPL (15)	GI.1/GII.4 (15/15)	GI.1/GII.4 (15/50)	GI.1/GII.4 (50/50)	GI.1/GII.4 (50/150)	GI.1/GII.4 (15/50) - Al(OH)3 (167)	GI.1/GII.4 (15/50) x2	GI.1/GII.4 (50/150) x2	GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Number of subjects analysed	30	29	28	29	30	31	30	32	28	30	24	28	29	30
Units: titer
geometric mean (standard deviation)
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)	1 ( 1.17 )	1 ( 1.18 )	0.9 ( 1.12 )	1 ( 1.22 )	1 ( 1.11 )	0.9 ( 1.22 )	0.9 ( 1.18 )	1 ( 1.67 )	0.9 ( 1.98 )	1 ( 1.12 )	1 ( 1.13 )	7.4 ( 2.97 )	4.5 ( 2.94 )	5.7 ( 3.01 )
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)	3.4 ( 2.91 )	5.1 ( 2.78 )	1.7 ( 1.81 )	2.6 ( 2.78 )	4.2 ( 3.2 )	3.7 ( 3.17 )	1.6 ( 2.06 )	5.9 ( 4.17 )	2.7 ( 3.16 )	4.6 ( 2.73 )	3.1 ( 2.36 )	4.6 ( 2.94 )	3.6 ( 2.62 )	4 ( 2.45 )

No statistical analyses for this end point

Secondary: GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)

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End point title

GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA) ^[17]

End point description

End point type

Secondary

End point timeframe

Days 208 and 393

Notes
[17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: No statistical analysis is reported for this endpoint.

End point values	GI.1/GII.4 (15/50) - MPL (15)	GI.1/GII.4 (15/50)
Number of subjects analysed	30	32
Units: titer
geometric mean (standard deviation)
D208 (n=30,32)	1.8 ( 2.34 )	2.4 ( 2.89 )
D393 (n=30,32)	1.4 ( 2.08 )	1.9 ( 2.56 )

No statistical analyses for this end point

Secondary: GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)

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End point title

GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)

End point description

GMFR of anti-norovirus GII.4 Sydney antibody titers as measured by HBGA binding assay. D=Day Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. “n” in the category is the number of participants with data available at the given time-point.

End point type

Secondary

End point timeframe

Days 28 and 56

End point values	GI.1/GII.4 (15/15) - MPL (50)	GI.1/GII.4 (15/50) - MPL (50)	GI.1/GII.4 (50/50) - MPL (50)	GI.1/GII.4 (15/15) - MPL (15)	GI.1/GII.4 (15/50) - MPL (15)	GI.1/GII.4 (50/50) - MPL (15)	GI.1/GII.4 (15/15)	GI.1/GII.4 (15/50)	GI.1/GII.4 (50/50)	GI.1/GII.4 (50/150)	GI.1/GII.4 (15/50) - Al(OH)3 (167)	GI.1/GII.4 (15/50) x2	GI.1/GII.4 (50/150) x2	GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Number of subjects analysed	30	29	28	29	30	31	30	32	28	30	24	28	29	30
Units: titer
geometric mean (standard deviation)
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)	0.9 ( 1.22 )	1 ( 1.26 )	0.9 ( 1.12 )	1 ( 1.18 )	0.9 ( 1.22 )	1 ( 1.09 )	0.9 ( 1.47 )	1.1 ( 1.91 )	1 ( 1.05 )	1 ( 1.25 )	1 ( 1.06 )	2.2 ( 2.48 )	2.5 ( 2.8 )	2.8 ( 2.77 )
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)	1.5 ( 2.59 )	2.3 ( 2.1 )	1.3 ( 1.67 )	1.3 ( 1.48 )	2 ( 2.46 )	1.7 ( 1.82 )	1.1 ( 1.6 )	2.9 ( 3.5 )	1.6 ( 1.77 )	2.5 ( 2.62 )	2 ( 2.02 )	1.8 ( 2.25 )	1.9 ( 2.3 )	2.1 ( 2.25 )

No statistical analyses for this end point

Secondary: GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)

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End point title

GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA) ^[18]

End point description

End point type

Secondary

End point timeframe

Days 208 and 393

Notes
[18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: No statistical analysis is reported for this endpoint.

End point values	GI.1/GII.4 (15/50) - MPL (15)	GI.1/GII.4 (15/50)
Number of subjects analysed	30	32
Units: titer
geometric mean (standard deviation)
D208 (n=30,32)	1.4 ( 1.93 )	1.6 ( 2.1 )
D393 (n=30,32)	1 ( 1.78 )	1.4 ( 2.28 )

No statistical analyses for this end point

Secondary: GMFR of Antibody Titers of Strains Not Represented in the Investigational Vaccine: Cross-Protection Assays

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End point title

GMFR of Antibody Titers of Strains Not Represented in the Investigational Vaccine: Cross-Protection Assays ^[19]

End point description

GMFR of anti-norovirus Cross-Protection Assays: GII.2 EC50, GI.3 EC50 and GII.4.2012 EC50 antibody titers as measured by HBGA binding assay. Data was collected for selected arms only. D=Day Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. Data was only collected for 2 of the arms.

End point type

Secondary

End point timeframe

Day 56

Notes
[19] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: No statistical analysis is reported for this endpoint.

End point values	GI.1/GII.4 (15/50) - MPL (15)	GI.1/GII.4 (15/50)
Number of subjects analysed	30	32
Units: titer
geometric mean (standard deviation)
GII.2 EC50	1.1 ( 1.92 )	0.8 ( 3.73 )
GI.3 EC50	5.9 ( 3.23 )	3 ( 3.36 )
GII.4.2012 EC50	3.2 ( 2.5 )	4.1 ( 3.51 )

No statistical analyses for this end point

Secondary: Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)

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End point title

Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)

End point description

Blocking titers 50 (BT50) of anti-norovirus GII.4 Cincinnati antibody titers as measured by HBGA binding assay. D=Day Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. “n” in the category is the number of participants with data available at the given time-point.

End point type

Secondary

End point timeframe

Day 1 (Baseline) and Days 28 and 56

End point values	GI.1/GII.4 (15/15) - MPL (50)	GI.1/GII.4 (15/50) - MPL (50)	GI.1/GII.4 (50/50) - MPL (50)	GI.1/GII.4 (15/15) - MPL (15)	GI.1/GII.4 (15/50) - MPL (15)	GI.1/GII.4 (50/50) - MPL (15)	GI.1/GII.4 (15/15)	GI.1/GII.4 (15/50)	GI.1/GII.4 (50/50)	GI.1/GII.4 (50/150)	GI.1/GII.4 (15/50) - Al(OH)3 (167)	GI.1/GII.4 (15/50) x2	GI.1/GII.4 (50/150) x2	GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Number of subjects analysed	30	29	28	29	30	31	30	32	28	30	24	28	29	30
Units: titer
geometric mean (standard deviation)
D1 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)	63.7 ( 4.34 )	75.1 ( 3.85 )	114.7 ( 4.28 )	85.8 ( 4.19 )	63 ( 4.08 )	89.1 ( 4.13 )	99.8 ( 4.47 )	85 ( 4.64 )	91.8 ( 4.02 )	112.6 ( 3.26 )	134.8 ( 3.07 )	54 ( 3.95 )	81.8 ( 3.86 )	93.2 ( 3.75 )
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)	63.6 ( 4.31 )	72.9 ( 3.95 )	113.8 ( 4.02 )	83.3 ( 4.05 )	61.7 ( 4.04 )	84.4 ( 4.23 )	90.5 ( 4.16 )	88 ( 5.49 )	78.6 ( 4.06 )	109 ( 3.25 )	130.6 ( 2.95 )	400 ( 3.57 )	366.9 ( 4.6 )	534.2 ( 3.17 )
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)	217.3 ( 3.57 )	380.7 ( 3.61 )	200.3 ( 4.33 )	221 ( 3.66 )	263.7 ( 5.77 )	327.5 ( 4.12 )	161.5 ( 4.66 )	501.4 ( 5.07 )	248.5 ( 4.56 )	518.8 ( 3.4 )	415.5 ( 4.11 )	248.3 ( 4.01 )	296.5 ( 4.12 )	373.4 ( 3.4 )

No statistical analyses for this end point

Secondary: Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)

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End point title

Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA) ^[20]

End point description

End point type

Secondary

End point timeframe

Days 208 and 393

Notes
[20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: No statistical analysis is reported for this endpoint.

End point values	GI.1/GII.4 (15/50) - MPL (15)	GI.1/GII.4 (15/50)
Number of subjects analysed	30	32
Units: titer
geometric mean (standard deviation)
D208 (n=30,32)	113.5 ( 5.03 )	202.5 ( 4.06 )
D393 (n=30,32)	88.9 ( 3.9 )	160.8 ( 3.96 )

No statistical analyses for this end point

Secondary: Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)

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End point title

Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)

End point description

Blocking Titers 50 (BT50) of anti-norovirus GII.4 Sydney antibody titers as measured by HBGA binding assay. D=Day Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. “n” in the category is the number of participants with data available at the given time-point.

End point type

Secondary

End point timeframe

Day 1 (Baseline) and Days 28 and 56

End point values	GI.1/GII.4 (15/15) - MPL (50)	GI.1/GII.4 (15/50) - MPL (50)	GI.1/GII.4 (50/50) - MPL (50)	GI.1/GII.4 (15/15) - MPL (15)	GI.1/GII.4 (15/50) - MPL (15)	GI.1/GII.4 (50/50) - MPL (15)	GI.1/GII.4 (15/15)	GI.1/GII.4 (15/50)	GI.1/GII.4 (50/50)	GI.1/GII.4 (50/150)	GI.1/GII.4 (15/50) - Al(OH)3 (167)	GI.1/GII.4 (15/50) x2	GI.1/GII.4 (50/150) x2	GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Number of subjects analysed	30	29	28	29	30	31	30	32	28	30	24	28	29	30
Units: titer
geometric mean (standard deviation)
D1 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)	35 ( 3.86 )	26 ( 2.3 )	43.3 ( 3.29 )	32.4 ( 3.24 )	28.3 ( 2.45 )	37.5 ( 3.18 )	29.7 ( 3.34 )	28 ( 2.93 )	32.2 ( 3.09 )	28.1 ( 2.31 )	32.3 ( 2.79 )	21.6 ( 2.11 )	29.7 ( 2.48 )	37.3 ( 3.42 )
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)	32.6 ( 3.49 )	24.8 ( 2.29 )	42.5 ( 3.1 )	31.1 ( 3.12 )	26.4 ( 2.44 )	36.3 ( 3.09 )	25.9 ( 3.08 )	30.2 ( 3.87 )	32.9 ( 3.09 )	27.8 ( 2.28 )	31.8 ( 2.73 )	48 ( 3.37 )	75.1 ( 3.35 )	104.8 ( 3.35 )
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)	53.5 ( 3.93 )	59.3 ( 2.79 )	56.7 ( 3.06 )	40.6 ( 3.37 )	55.5 ( 3.33 )	62.1 ( 3.26 )	31.2 ( 3.04 )	80.6 ( 4.37 )	51.2 ( 3.31 )	70.4 ( 3.22 )	64.4 ( 3.52 )	38.8 ( 2.98 )	56.7 ( 3.15 )	79.1 ( 3.18 )

No statistical analyses for this end point

Secondary: Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)

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End point title

Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA) ^[21]

End point description

End point type

Secondary

End point timeframe

Days 208 and 393

Notes
[21] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: No statistical analysis is reported for this endpoint.

End point values	GI.1/GII.4 (15/50) - MPL (15)	GI.1/GII.4 (15/50)
Number of subjects analysed	30	32
Units: titer
geometric mean (standard deviation)
D208 (n=30,32)	40.2 ( 3.14 )	44.2 ( 3.17 )
D393 (n=30,32)	28.5 ( 2.37 )	38.3 ( 2.87 )

No statistical analyses for this end point

Secondary: Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GII.2 EC50 (HBGA)

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End point title

Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GII.2 EC50 (HBGA) ^[22]

End point description

Blocking titers 50 (BT50) of anti-norovirus Cross-Protection Assay: GII.2 EC50 antibody titers as measured by HBGA binding assay. Data was collected for selected arms only. D=Day Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. Data was only collected for 2 of the arms.

End point type

Secondary

End point timeframe

Day 1 (Baseline) and Day 56

Notes
[22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: No statistical analysis is reported for this endpoint.

End point values	GI.1/GII.4 (15/50) - MPL (15)	GI.1/GII.4 (15/50)
Number of subjects analysed	30	32
Units: titer
geometric mean (standard deviation)
Day 1	266.2 ( 2.62 )	265.5 ( 4.79 )
Day 56	295.8 ( 2.31 )	216.5 ( 4.46 )

No statistical analyses for this end point

Secondary: Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GI.3 EC50 (HBGA)

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End point title

Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GI.3 EC50 (HBGA) ^[23]

End point description

Blocking titers 50 (BT50) of anti-norovirus Cross-Protection Assay: GI.3 EC50 antibody titers as measured by HBGA binding assay. Data was collected for selected arms only. D=Day Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. Data was only collected for 2 of the arms.

End point type

Secondary

End point timeframe

Day 1 (Baseline) and Day 56

Notes
[23] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: No statistical analysis is reported for this endpoint.

End point values	GI.1/GII.4 (15/50) - MPL (15)	GI.1/GII.4 (15/50)
Number of subjects analysed	30	32
Units: titer
geometric mean (standard deviation)
Day 1	59.7 ( 2.98 )	74.1 ( 3.7 )
Day 56	350.5 ( 3.05 )	222.7 ( 5.09 )

No statistical analyses for this end point

Secondary: Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GII.4.2012 EC50 (HBGA)

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End point title

Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GII.4.2012 EC50 (HBGA) ^[24]

End point description

Blocking titers 50 (BT50) of anti-norovirus Cross-Protection Assay: GII.4.2012 EC50 antibody titers as measured by HBGA binding assay. Data was collected for selected arms only. D=Day Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. Data was only collected for 2 of the arms.

End point type

Secondary

End point timeframe

Day 1 (Baseline) and Day 56

Notes
[24] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: No statistical analysis is reported for this endpoint.

End point values	GI.1/GII.4 (15/50) - MPL (15)	GI.1/GII.4 (15/50)
Number of subjects analysed	30	32
Units: titer
geometric mean (standard deviation)
Day 1	45.5 ( 4.07 )	50.7 ( 5.1 )
Day 56	146.6 ( 3.11 )	208.5 ( 3.8 )

No statistical analyses for this end point

Secondary: Percentage of Participants With Significant New Medical Conditions

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End point title

Percentage of Participants With Significant New Medical Conditions

End point description

Significant new medical conditions will be evaluated by the investigator for the co-existence of any of the following conditions: Adverse events of special interest (AESIs) are predefined events for potential immune mediated disorders. All AESIs are medically evaluated to assess if they might indicate an immune-mediated disorder. Immune mediated events (IMEs) are AEs that represent a new diagnosis of a chronic medical condition that was not present or suspected prior to enrollment. Safety Analysis Set included all participants who received at least one dose of trial vaccine.

End point type

Secondary

End point timeframe

Day 1 up to Day 56

End point values	GI.1/GII.4 (15/15) - MPL (50)	GI.1/GII.4 (15/50) - MPL (50)	GI.1/GII.4 (50/50) - MPL (50)	GI.1/GII.4 (15/15) - MPL (15)	GI.1/GII.4 (15/50) - MPL (15)	GI.1/GII.4 (50/50) - MPL (15)	GI.1/GII.4 (15/15)	GI.1/GII.4 (15/50)	GI.1/GII.4 (50/50)	GI.1/GII.4 (50/150)	GI.1/GII.4 (15/50) - Al(OH)3 (167)	GI.1/GII.4 (15/50) x2	GI.1/GII.4 (50/150) x2	GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Number of subjects analysed	30	30	30	31	30	31	30	32	29	30	29	28	29	31
Units: percentage of participants
number (not applicable)
AESIs	6.7	3.3	0	6.5	0	0	6.7	6.3	0	0	0	7.1	3.4	0
IMEs	0	0	0	0	0	0	0	0	0	0	0	0	0	0

No statistical analyses for this end point

Secondary: Percentage of Participants With Any Adverse Event (AE) Leading to Withdrawal From the Study

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End point title

Percentage of Participants With Any Adverse Event (AE) Leading to Withdrawal From the Study

End point description

Withdrawal due to an AE will occur if the participant experiences an AE that requires early termination because continued participation imposes an unacceptable risk to the participant’s health or the participants is unwilling to continue because of the AE. Safety Analysis Set included all participants who received at least one dose of trial vaccine.

End point type

Secondary

End point timeframe

Day 1 up to Day 56

End point values	GI.1/GII.4 (15/15) - MPL (50)	GI.1/GII.4 (15/50) - MPL (50)	GI.1/GII.4 (50/50) - MPL (50)	GI.1/GII.4 (15/15) - MPL (15)	GI.1/GII.4 (15/50) - MPL (15)	GI.1/GII.4 (50/50) - MPL (15)	GI.1/GII.4 (15/15)	GI.1/GII.4 (15/50)	GI.1/GII.4 (50/50)	GI.1/GII.4 (50/150)	GI.1/GII.4 (15/50) - Al(OH)3 (167)	GI.1/GII.4 (15/50) x2	GI.1/GII.4 (50/150) x2	GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Number of subjects analysed	30	30	30	31	30	31	30	32	29	30	29	28	29	31
Units: percentage of participants
number (not applicable)	0	0	0	0	0	0	0	0	0	0	0	0	0	0

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)

Adverse event reporting additional description

At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

18.0

Reporting group title

GI.1/GII.4 (15/15) - MPL (50)

Reporting group description

Reporting group title

GI.1/GII.4 (15/50) - MPL (50)

Reporting group description

Reporting group title

GI.1/GII.4 (50/50) - MPL (50)

Reporting group description

Reporting group title

GI.1/GII.4 (15/15) - MPL (15)

Reporting group description

Reporting group title

GI.1/GII.4 (15/50) - MPL (15)

Reporting group description

Reporting group title

GI.1/GII.4 (50/50) - MPL (15)

Reporting group description

Reporting group title

GI.1/GII.4 (15/15)

Reporting group description

Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.

Reporting group title

GI.1/GII.4 (15/50)

Reporting group description

Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.

Reporting group title

GI.1/GII.4 (50/50)

Reporting group description

Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.

Reporting group title

GI.1/GII.4 (50/150)

Reporting group description

Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.

Reporting group title

GI.1/GII.4 (15/50) - Al(OH)3 (167)

Reporting group description

Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.

Reporting group title

GI.1/GII.4 (15/50) x2

Reporting group description

Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.

Reporting group title

GI.1/GII.4 (50/150) x2

Reporting group description

Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.

Reporting group title

GI.1/GII.4 (15/50) - Al(OH)3 (167) x2

Reporting group description

Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.

GI.1/GII.4 (15/15) - MPL (50)

GI.1/GII.4 (15/50) - MPL (50)

GI.1/GII.4 (50/50) - MPL (50)

GI.1/GII.4 (15/15) - MPL (15)

GI.1/GII.4 (15/50) - MPL (15)

GI.1/GII.4 (50/50) - MPL (15)

GI.1/GII.4 (15/15)

GI.1/GII.4 (15/50)

GI.1/GII.4 (50/50)

GI.1/GII.4 (50/150)

GI.1/GII.4 (15/50) - Al(OH)3 (167)

GI.1/GII.4 (15/50) x2

GI.1/GII.4 (50/150) x2

GI.1/GII.4 (15/50) - Al(OH)3 (167) x2

Total subjects affected by serious adverse events

subjects affected / exposed

2 / 30 (6.67%)

0 / 30 (0.00%)

5 / 30 (16.67%)

2 / 31 (6.45%)

1 / 30 (3.33%)

0 / 31 (0.00%)

3 / 30 (10.00%)

3 / 32 (9.38%)

1 / 29 (3.45%)

1 / 30 (3.33%)

1 / 29 (3.45%)

2 / 28 (7.14%)

1 / 29 (3.45%)

1 / 31 (3.23%)

number of deaths (all causes)

number of deaths resulting from adverse events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Cervix carcinoma

subjects affected / exposed

0 / 30 (0.00%)

0 / 31 (0.00%)

0 / 30 (0.00%)

0 / 31 (0.00%)

1 / 30 (3.33%)

0 / 32 (0.00%)

0 / 29 (0.00%)

0 / 30 (0.00%)

0 / 29 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 31 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Rectal adenocarcinoma

subjects affected / exposed

0 / 30 (0.00%)

0 / 31 (0.00%)

0 / 30 (0.00%)

0 / 31 (0.00%)

0 / 30 (0.00%)

0 / 32 (0.00%)

0 / 29 (0.00%)

0 / 30 (0.00%)

0 / 29 (0.00%)

1 / 28 (3.57%)

0 / 29 (0.00%)

0 / 31 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Injury, poisoning and procedural complications

Compression fracture

subjects affected / exposed

0 / 30 (0.00%)

0 / 31 (0.00%)

0 / 30 (0.00%)

0 / 31 (0.00%)

1 / 30 (3.33%)

0 / 32 (0.00%)

0 / 29 (0.00%)

0 / 30 (0.00%)

0 / 29 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 31 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Tendon injury

subjects affected / exposed

0 / 30 (0.00%)

1 / 30 (3.33%)

0 / 31 (0.00%)

0 / 30 (0.00%)

0 / 31 (0.00%)

0 / 30 (0.00%)

0 / 32 (0.00%)

0 / 29 (0.00%)

0 / 30 (0.00%)

0 / 29 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 31 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Tendon rupture

subjects affected / exposed

0 / 30 (0.00%)

1 / 30 (3.33%)

0 / 31 (0.00%)

0 / 30 (0.00%)

0 / 31 (0.00%)

0 / 30 (0.00%)

0 / 32 (0.00%)

0 / 29 (0.00%)

0 / 30 (0.00%)

0 / 29 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 31 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Nervous system disorders

Transient ischaemic attack

subjects affected / exposed

0 / 30 (0.00%)

1 / 30 (3.33%)

0 / 31 (0.00%)

0 / 30 (0.00%)

0 / 31 (0.00%)

0 / 30 (0.00%)

0 / 32 (0.00%)

0 / 29 (0.00%)

0 / 30 (0.00%)

0 / 29 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 31 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastrointestinal disorders

Abdominal pain upper

subjects affected / exposed

0 / 30 (0.00%)

0 / 31 (0.00%)

0 / 30 (0.00%)

0 / 31 (0.00%)

0 / 30 (0.00%)

0 / 32 (0.00%)

0 / 29 (0.00%)

0 / 30 (0.00%)

0 / 29 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

1 / 31 (3.23%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Intestinal polyp

subjects affected / exposed

0 / 30 (0.00%)

0 / 31 (0.00%)

0 / 30 (0.00%)

0 / 31 (0.00%)

1 / 30 (3.33%)

0 / 32 (0.00%)

0 / 29 (0.00%)

0 / 30 (0.00%)

0 / 29 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 31 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Large intestinal polyp

subjects affected / exposed

0 / 30 (0.00%)

0 / 31 (0.00%)

0 / 30 (0.00%)

0 / 31 (0.00%)

0 / 30 (0.00%)

0 / 32 (0.00%)

1 / 29 (3.45%)

0 / 30 (0.00%)

0 / 29 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 31 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hepatobiliary disorders

Biliary colic

subjects affected / exposed

0 / 30 (0.00%)

0 / 31 (0.00%)

0 / 30 (0.00%)

0 / 31 (0.00%)

0 / 30 (0.00%)

1 / 32 (3.13%)

0 / 29 (0.00%)

0 / 30 (0.00%)

0 / 29 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

0 / 31 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cholelithiasis

subjects affected / exposed

0 / 30 (0.00%)

1 / 30 (3.33%)

0 / 31 (0.00%)

0 / 30 (0.00%)

0 / 31 (0.00%)

0 / 30 (0.00%)

0 / 32 (0.00%)

0 / 29 (0.00%)

0 / 30 (0.00%)

0 / 29 (0.00%)

0 / 28 (0.00%)

0 / 29 (0.00%)

1 / 31 (3.23%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

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Clinical trials

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Participants With a Seroresponse (Pan-Ig ELISA)

Primary: Percentage of Participants With a Seroresponse (Pan-Ig ELISA)

Primary: Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1

Primary: Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1

Primary: Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2

Primary: Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2

Primary: Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1

Primary: Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1

Primary: Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2

Primary: Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2

Primary: Oral Body Temperature Within 7 Days After Dose 1

Primary: Oral Body Temperature Within 7 Days After Dose 1

Primary: Oral Body Temperature Within 7 Days After Dose 2

Primary: Oral Body Temperature Within 7 Days After Dose 2

Primary: Percentage of Participants With Unsolicited Adverse Events (AEs)

Primary: Percentage of Participants With Unsolicited Adverse Events (AEs)

Primary: Percentage of Participants With Serious Adverse Events (SAEs)

Primary: Percentage of Participants With Serious Adverse Events (SAEs)

Secondary: Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)

Secondary: Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)

Secondary: Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)

Secondary: Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)

Secondary: Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)

Secondary: Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)

Secondary: Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)

Secondary: Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)

Secondary: Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)

Secondary: Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)

Secondary: Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)

Secondary: Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)

Secondary: Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)

Secondary: Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)

Secondary: Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)

Secondary: Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)

Secondary: Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)

Secondary: Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)

Secondary: Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)

Secondary: Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)

Secondary: Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)

Secondary: Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)

Secondary: Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)

Secondary: Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)

Secondary: Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)

Secondary: Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)

Secondary: Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)

Secondary: Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)

Secondary: Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)

Secondary: Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)

Secondary: Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)

Secondary: Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)

Secondary: Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)

Secondary: Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)

Secondary: Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)

Secondary: Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)

Secondary: Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)

Secondary: Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)

Secondary: Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)

Secondary: Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)

Secondary: Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)

Secondary: Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)

Secondary: Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)

Secondary: Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)

Secondary: Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)

Secondary: Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)

Secondary: Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)

Secondary: Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)

Secondary: Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)

Secondary: Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)

Secondary: Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)

Secondary: Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)

Secondary: Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)