Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalen... | NCT02661490

ID	Type	Description	Link
U1111-1162-4913	Registry Identifier	WHO

Description Module

Detailed Description

The vaccine being tested in this study is called norovirus GI.1/GII.4 bivalent virus-like particle (VLP) vaccine adjuvanted with aluminum hydroxide (Formulation A) or adjuvanted with monophosphoryl lipid A (MPL) and aluminum hydroxide (Formulation B). Two norovirus vaccine formulations are being tested to select for further development the formulation that will generate an optimal specific antibody response that may provide protection against norovirus and is safe in a population aged 60 years and above. This study will look at side effects and the level of antibodies to norovirus formed in people who will be injected with different formulations of the norovirus vaccine candidate.

The study will enroll approximately 325 patients. Participants will be randomly assigned (by chance) to one of five treatment groups.

Norovirus GI.1/GII.4 bivalent VLP vaccine (Formulation A) 1-dose, participants ≥ 60 years
Norovirus GI.1/GII.4 bivalent VLP vaccine (Formulation A) 2-dose, participants ≥ 60 years
Norovirus GI.1/GII.4 bivalent VLP vaccine (Formulation B) 1-dose, participants ≥ 60 years
Norovirus GI.1/GII.4 bivalent VLP vaccine (Formulation B) 2-dose, participants ≥ 60 years
Norovirus GI.1/GII.4 bivalent VLP vaccine (Formulation A) 1-dose, participants 18 to 49 years All participants in the age of 60 years and older will be administered either NoV vaccine (Formulation A or B) or placebo on Day 1 and NoV vaccine (Formulation A or B) on Day 29 of the study. In order to keep the treatment arms undisclosed to the patient and the doctor, those randomized to the one dose groups will receive a dose of placebo (this is a saline solution that has no active ingredient) on Day 1 followed by the NoV vaccine on Day 29. Those randomized to 2 doses with receive the NoV vaccine on Day 1 and Day 29. In case of an urgent medical need a participant can be unblinded.

Adults aged 18 to 49 will receive placebo on Day 1 followed by NoV vaccine Formulation A on Day 29.

Participants will be asked to record any reactions/ symptoms that may be related or not to the vaccine in a diary card for 28 days after each vaccination.

This multi-center trial will be conducted in the United States of America. The overall time to participate in this study is up to 393 days. Participants will make multiple visits to the clinic including a final follow-up visit on Day 393.

Label	Type	Description	Intervention Names
Arm 1: NoV Vaccine Formulation A _1-Dose	Experimental	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.	Biological: Norovirus GI.1/GII.4 Bivalent VLP Vaccine Drug: 0.9% sodium chloride (saline)
Arm 2: NoV Vaccine Formulation A _2-Dose	Experimental	Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.	Biological: Norovirus GI.1/GII.4 Bivalent VLP Vaccine
Arm 3: NoV Vaccine Formulation B_1-Dose	Experimental	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.	Drug: 0.9% sodium chloride (saline) Biological: Norovirus GI.1/GII.4 Bivalent VLP Vaccine
Arm 4: NoV Vaccine Formulation B_2-Dose	Experimental	Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29.	Biological: Norovirus GI.1/GII.4 Bivalent VLP Vaccine

Name	Type	Description	Arm Group Labels	Other Names
Norovirus GI.1/GII.4 Bivalent VLP Vaccine	Biological	Norovirus GI.1/GII.4 bivalent VLP vaccine adjuvanted with aluminum hydroxide, without MPL for IM injection	Arm 1: NoV Vaccine Formulation A _1-Dose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 and GII.4 Virus Like Particles (VLP) as Measured by Histoblood Group Antigen (HBGA) Blocking Assay on Day 57		Day 57
Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1	Solicited local AEs at the injection site that occurred within 7 days after each vaccination were collected using a diary and included pain, erythema swelling and induration.	Within 7 days of first vaccination on Day 1
Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29	Solicited local AEs at the injection site that occurred within 7 days after each vaccination were collected using a diary and included pain, erythema, swelling and induration.	Within 7 days of second vaccination on Day 29
Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1	Solicited systemic AEs that occurred within 7 days after each vaccination were collected using a diary and included headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea.	Within 7 days of first vaccination on Day 1
Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29	Solicited systemic AEs that occurred within 7 days after each vaccination were collected using a diary and included headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea.	Within 7 days of second vaccination on Day 29

Secondary Outcomes

Measure	Description	Time Frame
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 HBGA Blocking Assay		Days 8, 29, 36, 211 and 393
Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (HBGA)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Is aged 18 to 49 years, or 60 years and older at the time of enrollment;
Participants who are in good health, or in stable health status with no exclusionary medical or neuropsychiatric conditions at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and clinical judgment of the Investigator;
Participant signs and dates a written, Informed Consent Form (ICF) and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements;
Participants who can comply with trial procedures and are available for the duration of follow-up.

Exclusion Criteria:

Has a known hypersensitivity or allergy to any of the Norovirus (NoV) GI.1/GII.4 Bivalent virus-like particle (VLP) Vaccine components;
Has a clinically significant active infection (as assessed by the Investigator) or body temperature ≥38°C/100.4°F within 3 days of the intended date of vaccination;
Participants with the presence of significant acute or chronic, uncontrolled medical or neuropsychiatric illness. Uncontrolled was defined as:

Requiring institution of new medical or surgical treatment within 3 months prior to immunization, or Requiring a change in medication dosage in the 3 months prior to immunization due to uncontrolled symptoms or drug toxicity (elective dosage adjustments in stable participants were acceptable), or Hospitalization or an event fulfilling the definition of a serious adverse event within 3 months prior immunization.
Has any unstable medical or neuropsychiatric condition, which in the Investigator's opinion poses a risk of unusual magnitude for the participant's age group of hospitalization, death, or an event meeting the definition of a serious adverse event within 2 months of immunization. The intent of this criterion is to recognize and allow for the frequent existence of significant health concerns in this population; but exclude those participants who are experiencing an acute decline in health status;
Has any medical or neuropsychiatric condition, which in the Investigator's opinion, rendered the participant incompetent to provide informed consent or unable to provide valid safety observations and reports;
Has behavioral or cognitive impairment or psychiatric disease that, in the opinion of the Investigator, may interfere with the participant's ability to participate in the trial;
Participants with any history of progressive or severe neurologic disorder, history of seizure, or history of neuro-inflammatory disease (e.g. Guillain-Barre syndrome);
Participants with history or any illness that, in the opinion of the Investigator, might interfere with the results of the trial or pose additional risk to the participants due to participation in the trial;
Has known or suspected autoimmune disease;
Has known or suspected impairment/alteration of immune function, including:

Chronic use of oral steroids (Equivalent to 20 mg/day prednisone ≥ 12 weeks/≥ 2 mg/kg body weight/day prednisone ≥ 2 weeks) within 60 days prior to Day 1 (use of inhaled, intranasal, or topical corticosteroids is allowed).

Receipt of parenteral steroids (Equivalent to 20 mg/day prednisone ≥ 12 weeks/≥ 2 mg/kg body weight/day prednisone ≥ 2 weeks) within 60 days prior to Day 1.

Receipt of immunosuppressive therapy within 3 months prior to Day 1. Receipt of immunostimulants within 60 days prior to Day 1. Receipt of parenteral, epidural or intra-articular immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to Day 1 or planned during the full length of the trial.

Human Immunodeficiency Virus (HIV) infection or HIV-related disease. Genetic immunodeficiency.
Has abnormalities of splenic or thymic function;
Has any significant disorder of coagulation or treatment with anticoagulant therapy that would increase the risk of intramuscular (IM) injection. Persons receiving prophylactic antiplatelet medication such as low dose of acetylsalicylic acid are eligible;
Has any serious chronic or progressive disease according to judgment of the Investigator: cancer (malignancy other than resolved/excised skin lesion), insulin dependent Type I diabetes (Type II diabetes is accepted), cardiac, renal or hepatic disease;
Has body mass index (BMI) greater than or equal to 35 kg/m^2 (= weight in kg/[height in meters^2]);
Is participating in any clinical trial with another investigational product 30 days prior to first trial visit or intent to participate in another clinical trial at any time during the conduct of this trial;
Participants who received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this trial or who are planning to receive any vaccine within 28 days of investigational vaccine administration;
Participants involved in trial conduct or their first degree relatives;
Has history of substance or alcohol abuse within the past 2 years;
Females who are pregnant or breastfeeding;
If female of childbearing potential, sexually active with a male partner who has not been sterilized, and has not used any of the "acceptable contraceptive methods" for at least 2 months prior to trial entry:

Of childbearing potential is defined as status post onset of menarche and not meeting any of the following conditions: menopausal for at least 2 years, status after bilateral tubal ligation for at least 1 year, status after bilateral oophorectomy, or status after hysterectomy.

Acceptable birth control methods are defined as one or more of the following: i. Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring); ii. Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse; iii. Intrauterine device (IUD); iv. Monogamous relationship with vasectomized partner. Partner must have been vasectomized for at least six months prior to the participants' trial entry.
If female of childbearing potential and sexually active, refusal to use an "acceptable contraceptive method" from Day 1 and throughout the duration of the trial. In addition, they must be advised not to donate ova during this period;
Females with any positive or indeterminate pregnancy test.

Name	Affiliation	Role
Medical Director Clinical Science	Takeda	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Simon Williamson Clinic		Birmingham	Alabama	35211	United States
Fountain Hills Family Practice, P.C.

ID	Title	Description
FG000	Arm 1: NoV Vaccine Formulation A_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
FG001

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
SAP	No	Yes	No	Statistical Analysis Plan	Feb 2, 2017	Apr 22, 2020

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Data is reported for elderly participants only.

Mean

Standard Deviation

years

Title	Denominators	Categories
	ParticipantsBG00076 ParticipantsBG00174 ParticipantsBG00272 ParticipantsBG003

Age, Continuous

Data is reported for young adult participants only.

Mean

Standard Deviation

years

Title	Denominators	Categories
	ParticipantsBG0000 ParticipantsBG0010 ParticipantsBG002

Sex: Female, Male

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00076 ParticipantsBG00174 ParticipantsBG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00076 ParticipantsBG00174 ParticipantsBG002

Race (NIH/OMB)

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00076 ParticipantsBG00174 ParticipantsBG002

Region of Enrollment

Count of Participants

Participants

Title	Denominators	Categories
United States	ParticipantsBG00076 ParticipantsBG00174 ParticipantsBG002

Height

Data is reported for elderly participants only.

Mean

Standard Deviation

Title	Denominators	Categories
	ParticipantsBG00076 ParticipantsBG00174 ParticipantsBG002

Height

Data is reported for young adult participants only for whom data for height was available at Baseline.

Mean

Standard Deviation

Title	Denominators	Categories
	ParticipantsBG0000 ParticipantsBG0010 ParticipantsBG002

Weight

Data is reported for elderly participants only.

Mean

Standard Deviation

Title	Denominators	Categories
	ParticipantsBG00076 ParticipantsBG00174 ParticipantsBG002

Weight

Data is reported for young adult participants only for whom data for weight was available at Baseline.

Mean

Standard Deviation

Title	Denominators	Categories
	ParticipantsBG0000 ParticipantsBG0010 ParticipantsBG002

Body Mass Index (BMI)

BMI=Weight (kg)/height (m^2)

Data is reported for elderly participants only.

Mean

Standard Deviation

kg/m^2

Title	Denominators	Categories
	ParticipantsBG00076 ParticipantsBG00174 ParticipantsBG002

Body Mass Index (BMI)

BMI=Weight (kg)/height (m^2)

Data is reported for young adult participants only for whom data for BMI was available at Baseline.

Mean

Standard Deviation

kg/m^2

Title	Denominators	Categories
	ParticipantsBG0000 ParticipantsBG0010 ParticipantsBG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 and GII.4 Virus Like Particles (VLP) as Measured by Histoblood Group Antigen (HBGA) Blocking Assay on Day 57

Per Protocol Set (PPS) included all participants in the Full Analysis Set (FAS), who receive the planned vaccination [both doses of vaccine, i.e. Norovirus (NoV) VLP vaccine or placebo], and did not have major protocol violations. Overall number of participants analyzed is the number of participants with data available for analyses.

Posted

Number

95% Confidence Interval

percentage of participants

Day 57

ID	Title	Description
OG000	Arm 1: NoV Vaccine Formulation A_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
OG001	Arm 2: NoV Vaccine Formulation A_2-Dose	Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
OG002	Arm 3: NoV Vaccine Formulation B_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.
OG003	Arm 4: NoV Vaccine Formulation B_2-Dose	Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29.
OG004	Arm 5: NoV Vaccine Formulation A_1-Dose	Participants 18 to 49 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29.

Units	Counts
Participants	OG00071 OG00165 OG00262 OG003

Title

Denominators

Categories

Title	Measurements
	OG00042.3(30.6 to 54.6) OG00141.5(29.4 to 54.4) OG00256.5(43.3 to 69.0) OG003

Primary

Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1

Solicited local AEs at the injection site that occurred within 7 days after each vaccination were collected using a diary and included pain, erythema swelling and induration.

Safety Analysis Set (SAF) included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo). Number analyzed is the number of participants with evaluable data for the specific category.

Posted

Number

percentage of participants

Within 7 days of first vaccination on Day 1

ID	Title	Description
OG000	Arm 1: NoV Vaccine Formulation A_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
OG001	Arm 2: NoV Vaccine Formulation A_2-Dose	Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
OG002	Arm 3: NoV Vaccine Formulation B_1-Dose

Primary

Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29

Solicited local AEs at the injection site that occurred within 7 days after each vaccination were collected using a diary and included pain, erythema, swelling and induration.

SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo). Overall number of participants analyzed is the number of participants with data available for analyses.

Posted

Number

percentage of participants

Within 7 days of second vaccination on Day 29

ID	Title	Description
OG000	Arm 1: NoV Vaccine Formulation A_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
OG001	Arm 2: NoV Vaccine Formulation A_2-Dose	Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
OG002	Arm 3: NoV Vaccine Formulation B_1-Dose

Primary

Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1

Solicited systemic AEs that occurred within 7 days after each vaccination were collected using a diary and included headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea.

SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo). Number analyzed is the number of participants with evaluable data for the specific category.

Posted

Number

percentage of participants

Within 7 days of first vaccination on Day 1

ID	Title	Description
OG000	Arm 1: NoV Vaccine Formulation A_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
OG001	Arm 2: NoV Vaccine Formulation A_2-Dose	Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
OG002	Arm 3: NoV Vaccine Formulation B_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.

Primary

Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29

Solicited systemic AEs that occurred within 7 days after each vaccination were collected using a diary and included headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea.

Posted

Number

percentage of participants

Within 7 days of second vaccination on Day 29

ID	Title	Description
OG000	Arm 1: NoV Vaccine Formulation A_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
OG001	Arm 2: NoV Vaccine Formulation A_2-Dose	Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
OG002	Arm 3: NoV Vaccine Formulation B_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.

Primary

Percentage of Participants With Elevated Body Temperature ≥38°C (Defined as Fever) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1

The body temperature measurement was performed using the thermometer for 7 days after each vaccination. The highest body temperature observed each day was recorded on the diary card. An elevated temperature is ≥ 38 °C or 100.4°F (considered as fever).

Posted

Number

percentage of participants

Within 7 days of first vaccination on Day 1

ID	Title	Description
OG000	Arm 1: NoV Vaccine Formulation A_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
OG001	Arm 2: NoV Vaccine Formulation A_2-Dose	Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
OG002	Arm 3: NoV Vaccine Formulation B_1-Dose

Primary

Percentage of Participants With Elevated Body Temperature ≥38°C (Defined as Fever) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29

Posted

Number

percentage of participants

Within 7 days of second vaccination on Day 29

ID	Title	Description
OG000	Arm 1: NoV Vaccine Formulation A_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
OG001	Arm 2: NoV Vaccine Formulation A_2-Dose	Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
OG002	Arm 3: NoV Vaccine Formulation B_1-Dose

Primary

Percentage of Participants With At Least One Unsolicited Adverse Event (AE) Within 28-days After First Vaccination on Day 1

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.

SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).

Posted

Number

percentage of participants

Within 28 days of first vaccination on Day 1

ID	Title	Description
OG000	Arm 1: NoV Vaccine Formulation A_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
OG001	Arm 2: NoV Vaccine Formulation A_2-Dose	Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
OG002	Arm 3: NoV Vaccine Formulation B_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.

Primary

Percentage of Participants With At Least One Unsolicited Adverse Event (AE) Within 28-days After Second Vaccination on Day 29

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.

SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo). Overall number of participants analyzed is number of participants with data available for analyses.

Posted

Number

percentage of participants

Within 28 days of second vaccination on Day 29

ID	Title	Description
OG000	Arm 1: NoV Vaccine Formulation A_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
OG001	Arm 2: NoV Vaccine Formulation A_2-Dose	Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
OG002	Arm 3: NoV Vaccine Formulation B_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.

Primary

Percentage of Participants With At Least One Serious Adverse Event (SAE)

An SAE is any untoward medical occurrence 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.

SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).

Posted

Number

percentage of participants

From first vaccination up to Day 393

ID	Title	Description
OG000	Arm 1: NoV Vaccine Formulation A_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
OG001	Arm 2: NoV Vaccine Formulation A_2-Dose	Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
OG002	Arm 3: NoV Vaccine Formulation B_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.

Secondary

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 HBGA Blocking Assay

PPS included all participants in the FAS, who received the planned vaccination (both doses of vaccine, i.e. NoV VLP vaccine or placebo), and did not have major protocol violations. Number analyzed is the number of participants with evaluable data at the given time point.

Posted

Number

95% Confidence Interval

percentage of participants

Days 8, 29, 36, 211 and 393

ID	Title	Description
OG000	Arm 1: NoV Vaccine Formulation A_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
OG001	Arm 2: NoV Vaccine Formulation A_2-Dose	Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
OG002	Arm 3: NoV Vaccine Formulation B_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.

Secondary

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

Posted

Number

95% Confidence Interval

percentage of participants

Days 8, 29, 36, 57, 211 and 393

ID	Title	Description
OG000	Arm 1: NoV Vaccine Formulation A_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
OG001	Arm 2: NoV Vaccine Formulation A_2-Dose	Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
OG002	Arm 3: NoV Vaccine Formulation B_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.

Secondary

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

Posted

Number

95% Confidence Interval

percentage of participants

Days 8, 29, 36, 57, 211 and 393

ID	Title	Description
OG000	Arm 1: NoV Vaccine Formulation A_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
OG001	Arm 2: NoV Vaccine Formulation A_2-Dose	Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
OG002	Arm 3: NoV Vaccine Formulation B_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.

Secondary

Geometric Mean Titer (GMT) GI.1 VLP Antibody Titers (HBGA)

GMT GI.1 VLP antibody titers measured by HBGA blocking assay are reported.

Posted

Geometric Mean

95% Confidence Interval

titer

Baseline (Day 1), Days 8, 29, 36, 57, 211 and 393

ID	Title	Description
OG000	Arm 1: NoV Vaccine Formulation A_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
OG001	Arm 2: NoV Vaccine Formulation A_2-Dose	Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
OG002	Arm 3: NoV Vaccine Formulation B_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.

Secondary

GMT of Anti-norovirus GII.4 VLP Antibody Titers (HBGA)

GMT of anti-norovirus GII.4 VLP antibody titers measured by HBGA blocking assay are reported.

Posted

Geometric Mean

95% Confidence Interval

titer

Baseline (Day 1), Days 8, 29, 36, 57, 211 and 393

ID	Title	Description
OG000	Arm 1: NoV Vaccine Formulation A_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
OG001	Arm 2: NoV Vaccine Formulation A_2-Dose	Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
OG002	Arm 3: NoV Vaccine Formulation B_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.

Secondary

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

GMFR of anti-norovirus GI.1 VLP antibody titers measured by HBGA blocking assay are reported. The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level.

Posted

Geometric Mean

95% Confidence Interval

ratio

Days 8, 29, 36, 57, 211 and 393

ID	Title	Description
OG000	Arm 1: NoV Vaccine Formulation A_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
OG001	Arm 2: NoV Vaccine Formulation A_2-Dose	Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
OG002	Arm 3: NoV Vaccine Formulation B_1-Dose

Secondary

GMFR of Anti-norovirus GII.4 VLP Antibody Titers (HBGA)

GMFR of anti-norovirus GII.4 VLP antibody titers measured by HBGA blocking assay are reported. The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level.

Posted

Geometric Mean

95% Confidence Interval

ratio

Days 8, 29, 36, 57, 211 and 393

ID	Title	Description
OG000	Arm 1: NoV Vaccine Formulation A_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
OG001	Arm 2: NoV Vaccine Formulation A_2-Dose	Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
OG002	Arm 3: NoV Vaccine Formulation B_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.

Secondary

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 Total Immunoglobulin-Enzyme-linked Immunosorbent Assay (Pan-Ig ELISA)

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 measured by Pan-Ig ELISA are reported.

Posted

Number

95% Confidence Interval

percentage of participants

Days 8, 29, 36, 57, 211 and 393

ID	Title	Description
OG000	Arm 1: NoV Vaccine Formulation A_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
OG001	Arm 2: NoV Vaccine Formulation A_2-Dose	Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
OG002	Arm 3: NoV Vaccine Formulation B_1-Dose

Secondary

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

Percentage of participants with a 4-Fold rise or greater in serum anti-norovirus GI.1 VLP antibody titers measured by Pan-Ig ELISA are reported.

Posted

Number

95% Confidence Interval

percentage of participants

Days 8, 29, 36, 57, 211 and 393

ID	Title	Description
OG000	Arm 1: NoV Vaccine Formulation A_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
OG001	Arm 2: NoV Vaccine Formulation A_2-Dose	Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
OG002	Arm 3: NoV Vaccine Formulation B_1-Dose

Secondary

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

Percentage of participants with a 4-fold rise or greater in serum anti-norovirus GII.4 VLP antibody titers measured by Pan-Ig ELISA are reported.

Posted

Number

95% Confidence Interval

percentage of participants

Days 8, 29, 36, 57, 211 and 393

ID	Title	Description
OG000	Arm 1: NoV Vaccine Formulation A_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
OG001	Arm 2: NoV Vaccine Formulation A_2-Dose	Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
OG002	Arm 3: NoV Vaccine Formulation B_1-Dose

Secondary

GMT of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA)

GMT of anti-norovirus GI.1 VLP antibody titers measured by Pan-Ig ELISA are reported.

Posted

Geometric Mean

95% Confidence Interval

titer

Baseline (Day 1), Days 8, 29, 36, 57, 211 and 393

ID	Title	Description
OG000	Arm 1: NoV Vaccine Formulation A_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
OG001	Arm 2: NoV Vaccine Formulation A_2-Dose	Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
OG002	Arm 3: NoV Vaccine Formulation B_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.

Secondary

GMT of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA)

GMT of anti-norovirus GII.4 VLP antibody titers measured by Pan-Ig ELISA are reported.

Posted

Geometric Mean

95% Confidence Interval

titer

Baseline (Day 1), Days 8, 29, 36, 57, 211 and 393

ID	Title	Description
OG000	Arm 1: NoV Vaccine Formulation A_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
OG001	Arm 2: NoV Vaccine Formulation A_2-Dose	Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
OG002	Arm 3: NoV Vaccine Formulation B_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.

Secondary

GMFR of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA)

GMFR of anti-norovirus GI.1 VLP antibody titers measured by Pan-Ig ELISA are reported. The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level.

Posted

Geometric Mean

95% Confidence Interval

ratio

Days 8, 29, 36, 57, 211 and 393

ID	Title	Description
OG000	Arm 1: NoV Vaccine Formulation A_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
OG001	Arm 2: NoV Vaccine Formulation A_2-Dose	Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
OG002	Arm 3: NoV Vaccine Formulation B_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.

Secondary

GMFR of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA)

GMFR of anti-norovirus GII.4 VLP antibody titers measured by Pan-Ig ELISA are reported. The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level.

Posted

Geometric Mean

95% Confidence Interval

ratio

Days 8, 29, 36, 57, 211 and 393

ID	Title	Description
OG000	Arm 1: NoV Vaccine Formulation A_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
OG001	Arm 2: NoV Vaccine Formulation A_2-Dose	Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
OG002	Arm 3: NoV Vaccine Formulation B_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.

Secondary

Percentage of Participants With At Least One Adverse Event of Special Interest (AESI)

AESIs are AEs that are not solicited local or systemic AEs, they are predefined AEs that required close monitoring and prompt reporting to the sponsor. AESI included protocol specified Cardiac Disorders, Gastrointestinal Disorders, Immune System Disorders, Infections and Infestations, Musculoskeletal and Connective Tissue Diseases, Neuroinflammatory Disorders, Renal and Urinary Disorders, Skin Disorders, Thyroid Disorders, Vascular Disorders and Other Disorders.

SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).

Posted

Number

percentage of participants

From first vaccination up to Day 393

ID	Title	Description
OG000	Arm 1: NoV Vaccine Formulation A_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
OG001	Arm 2: NoV Vaccine Formulation A_2-Dose	Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
OG002	Arm 3: NoV Vaccine Formulation B_1-Dose

Secondary

Percentage of Participants With At Least One Adverse Event (AE) Leading to Participant's Withdrawal From the Study

Withdrawal due to an AE will occur if the participant experiences an AE that requires early termination of treatment, because continued participation imposes an unacceptable risk to the participant's health or the participant is unwilling to continue because of the AE.

SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).

Posted

Number

percentage of participants

From first vaccination up to Day 393

ID	Title	Description
OG000	Arm 1: NoV Vaccine Formulation A_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
OG001	Arm 2: NoV Vaccine Formulation A_2-Dose	Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
OG002	Arm 3: NoV Vaccine Formulation B_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected76 at risk EG0010 affected74 at risk EG0021 affected72 at risk EG0030 affected72 at risk EG0040 affected25 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected76 at risk EG0010 affected74 at risk EG0022 affected72 at risk EG003
Aortic valve stenosis	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected76 at risk EG0010 affected74 at risk EG0021 affected72 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected76 at risk EG0011 affected74 at risk EG0021 affected72 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected76 at risk EG0010 affected74 at risk EG0021 affected72 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected76 at risk EG0010 affected74 at risk EG0020 affected72 at risk EG003
Aortic valve incompetence	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected76 at risk EG0010 affected74 at risk EG0021 affected72 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected76 at risk EG0010 affected74 at risk EG0021 affected72 at risk EG003
Atrioventricular block complete	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected76 at risk EG0010 affected74 at risk EG0020 affected72 at risk EG003
Atrioventricular block second degree	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected76 at risk EG0010 affected74 at risk EG0021 affected72 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected76 at risk EG0010 affected74 at risk EG0020 affected72 at risk EG003
Stress cardiomyopathy	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected76 at risk EG0010 affected74 at risk EG0021 affected72 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected76 at risk EG0010 affected74 at risk EG0020 affected72 at risk EG003
Vertigo positional	Ear and labyrinth disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected76 at risk EG0010 affected74 at risk EG0020 affected72 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected76 at risk EG0010 affected74 at risk EG0021 affected72 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected76 at risk EG0010 affected74 at risk EG0020 affected72 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected76 at risk EG0010 affected74 at risk EG0020 affected72 at risk EG003
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected76 at risk EG0010 affected74 at risk EG0020 affected72 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected76 at risk EG0010 affected74 at risk EG0021 affected72 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected76 at risk EG0010 affected74 at risk EG0021 affected72 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected76 at risk EG0010 affected74 at risk EG0021 affected72 at risk EG003
Complication associated with device	General disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected76 at risk EG0010 affected74 at risk EG0021 affected72 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected76 at risk EG0010 affected74 at risk EG0021 affected72 at risk EG003
Bile duct stone	Hepatobiliary disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected76 at risk EG0010 affected74 at risk EG0021 affected72 at risk EG003
Pneumonia	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0000 affected76 at risk EG0011 affected74 at risk EG0020 affected72 at risk EG003
Sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0000 affected76 at risk EG0010 affected74 at risk EG0021 affected72 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0000 affected76 at risk EG0010 affected74 at risk EG0021 affected72 at risk EG003
Bronchitis	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0000 affected76 at risk EG0010 affected74 at risk EG0021 affected72 at risk EG003
Diverticulitis	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0000 affected76 at risk EG0010 affected74 at risk EG0020 affected72 at risk EG003
Escherichia sepsis	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0000 affected76 at risk EG0010 affected74 at risk EG0020 affected72 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0000 affected76 at risk EG0010 affected74 at risk EG0021 affected72 at risk EG003
Splenic abscess	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0000 affected76 at risk EG0010 affected74 at risk EG0021 affected72 at risk EG003
Streptococcal endocarditis	Infections and infestations	MedDRA 20.0	Systematic Assessment		EG0000 affected76 at risk EG0010 affected74 at risk EG0021 affected72 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0000 affected76 at risk EG0011 affected74 at risk EG0022 affected72 at risk EG003
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0000 affected76 at risk EG0011 affected74 at risk EG0020 affected72 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0000 affected76 at risk EG0011 affected74 at risk EG0020 affected72 at risk EG003
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0001 affected76 at risk EG0010 affected74 at risk EG0020 affected72 at risk EG003
Periprosthetic fracture	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0000 affected76 at risk EG0011 affected74 at risk EG0020 affected72 at risk EG003
Procedural pneumothorax	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment		EG0000 affected76 at risk EG0010 affected74 at risk EG0020 affected72 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected76 at risk EG0011 affected74 at risk EG0021 affected72 at risk EG003
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected76 at risk EG0010 affected74 at risk EG0020 affected72 at risk EG003
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment		EG0000 affected76 at risk EG0010 affected74 at risk EG0020 affected72 at risk EG003
Bone cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment		EG0000 affected76 at risk EG0010 affected74 at risk EG0021 affected72 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment		EG0000 affected76 at risk EG0010 affected74 at risk EG0020 affected72 at risk EG003
Intraductal proliferative breast lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment		EG0000 affected76 at risk EG0011 affected74 at risk EG0020 affected72 at risk EG003
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment		EG0000 affected76 at risk EG0010 affected74 at risk EG0021 affected72 at risk EG003
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment		EG0001 affected76 at risk EG0010 affected74 at risk EG0020 affected72 at risk EG003
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 20.0	Systematic Assessment		EG0000 affected76 at risk EG0010 affected74 at risk EG0021 affected72 at risk EG003
Haemorrhagic stroke	Nervous system disorders	MedDRA 20.0	Systematic Assessment	One treatment-emergent death occurred during treatment with NoV vaccine (formulation B)-2 dose regimen and is not related. Same participant had metabolic encephalopathy and ruptured cerebral aneurysm.	EG0000 affected76 at risk EG0010 affected74 at risk EG0020 affected72 at risk EG003
Metabolic encephalopathy	Nervous system disorders	MedDRA 20.0	Systematic Assessment	One treatment-emergent death occurred during treatment with NoV vaccine (formulation B)-2 dose regimen and is not related. Same participant had haemorrhagic stroke and ruptured cerebral aneurysm.	EG0000 affected76 at risk EG0010 affected74 at risk EG0020 affected72 at risk EG003
Ruptured cerebral aneurysm	Nervous system disorders	MedDRA 20.0	Systematic Assessment	One treatment-emergent death occurred during treatment with NoV vaccine (formulation B)-2 dose regimen and is not related. Same participant had haemorrhagic stroke and metabolic encephalopathy.	EG0000 affected76 at risk EG0010 affected74 at risk EG0020 affected72 at risk EG003
Seizure	Nervous system disorders	MedDRA 20.0	Systematic Assessment	One treatment-emergent death occurred during treatment with NoV vaccine (formulation A)-2 dose regimen and is not related.	EG0000 affected76 at risk EG0011 affected74 at risk EG0020 affected72 at risk EG003
Delirium	Psychiatric disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected76 at risk EG0011 affected74 at risk EG0020 affected72 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment	One treatment-emergent death occurred during treatment with NoV vaccine (formulation A)-1 dose regimen and is not related.	EG0001 affected76 at risk EG0010 affected74 at risk EG0020 affected72 at risk EG003
Bladder outlet obstruction	Renal and urinary disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected76 at risk EG0010 affected74 at risk EG0021 affected72 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected76 at risk EG0011 affected74 at risk EG0021 affected72 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected76 at risk EG0010 affected74 at risk EG0020 affected72 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected76 at risk EG0010 affected74 at risk EG0020 affected72 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment		EG0001 affected76 at risk EG0010 affected74 at risk EG0020 affected72 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected76 at risk EG0011 affected74 at risk EG0020 affected72 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 20.0	Systematic Assessment		EG0000 affected76 at risk EG0010 affected74 at risk EG0021 affected72 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0008 affected76 at risk EG0018 affected74 at risk EG0025 affected72 at risk EG0033 affected72 at risk EG0041 affected25 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 affected76 at risk EG0014 affected74 at risk EG0020 affected72 at risk EG003
Bronchitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected76 at risk EG0011 affected74 at risk EG0022 affected72 at risk EG003
Pneumonia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected76 at risk EG0010 affected74 at risk EG0021 affected72 at risk EG003
Otitis media	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected76 at risk EG0010 affected74 at risk EG0020 affected72 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 affected76 at risk EG0010 affected74 at risk EG0020 affected72 at risk EG003
Injection site bruising	General disorders	MedDRA 20.0	Systematic Assessment	EG0004 affected76 at risk EG0011 affected74 at risk EG0024 affected72 at risk EG003
Fatigue	General disorders	MedDRA 20.0	Systematic Assessment	EG0003 affected76 at risk EG0013 affected74 at risk EG0021 affected72 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected76 at risk EG0011 affected74 at risk EG0021 affected72 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected76 at risk EG0010 affected74 at risk EG0022 affected72 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected76 at risk EG0011 affected74 at risk EG0021 affected72 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected76 at risk EG0010 affected74 at risk EG0023 affected72 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected76 at risk EG0010 affected74 at risk EG0020 affected72 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected76 at risk EG0010 affected74 at risk EG0021 affected72 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected76 at risk EG0011 affected74 at risk EG0021 affected72 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0004 affected76 at risk EG0013 affected74 at risk EG0022 affected72 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 affected76 at risk EG0012 affected74 at risk EG0021 affected72 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected76 at risk EG0012 affected74 at risk EG0021 affected72 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected76 at risk EG0011 affected74 at risk EG0020 affected72 at risk EG003
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0002 affected76 at risk EG0010 affected74 at risk EG0020 affected72 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected76 at risk EG0011 affected74 at risk EG0021 affected72 at risk EG003
Exposure to communicable disease	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0000 affected76 at risk EG0010 affected74 at risk EG0020 affected72 at risk EG003
Headache	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected76 at risk EG0012 affected74 at risk EG0023 affected72 at risk EG003
Dizziness	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected76 at risk EG0011 affected74 at risk EG0023 affected72 at risk EG003
Presyncope	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected76 at risk EG0010 affected74 at risk EG0020 affected72 at risk EG003
Poor quality sleep	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected76 at risk EG0010 affected74 at risk EG0020 affected72 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 affected76 at risk EG0011 affected74 at risk EG0020 affected72 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 affected76 at risk EG0012 affected74 at risk EG0020 affected72 at risk EG003
Hypertension	Vascular disorders	MedDRA 20.0	Systematic Assessment	EG0002 affected76 at risk EG0010 affected74 at risk EG0021 affected72 at risk EG003

ID	Term
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017670	Sodium Compounds

ID	Title	Description
BG000	Arm 1: NoV Vaccine Formulation A_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.
BG001	Arm 2: NoV Vaccine Formulation A_2-Dose	Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.
BG002	Arm 3: NoV Vaccine Formulation B_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.
BG003	Arm 4: NoV Vaccine Formulation B_2-Dose	Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29.
BG004	Arm 5: NoV Vaccine Formulation A_1-Dose	Participants 18 to 49 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29.
BG005	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Arm 1: NoV Vaccine Formulation A_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29.	1	76	7	76	28	76
EG001	Arm 2: NoV Vaccine Formulation A_2-Dose	Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29.	1	74	9	74	25	74
EG002	Arm 3: NoV Vaccine Formulation B_1-Dose	Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29.	0	72	17	72	23	72
EG003	Arm 4: NoV Vaccine Formulation B_2-Dose	Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29.	1	72	9	72	21	72
EG004	Arm 5: NoV Vaccine Formulation A_1-Dose	Participants 18 to 49 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29.	0	25	0	25	7	25