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Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent VLP Vaccine

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 Adults

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02038907
Acronym
NOR-107
Enrollment
420
Registered
2014-01-17
Start date
2014-03-28
Completion date
2015-06-19
Last updated
2017-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers, Norovirus, Prevention

Keywords

Norovirus, vaccination

Brief summary

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

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 and with or without monophosphoryl lipid A (MPL). The norovirus vaccine is being tested to assess different formulations of the vaccine that will then be further developed. This study will look at the number of antibodies to norovirus formed in people who take different formulations of the norovirus vaccine. The study will enroll approximately 420 patients. Participants will be randomly assigned (by chance) to one of fourteen treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need). All participants will receive a vaccination on Day 1 and Day 28 of the study. Some treatment arms will receive one dose of the norovirus vaccine and some arms will receive two. 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 Hepatitis A vaccine on Day 1 followed by the norovirus vaccine 28 days later. Participants will be asked to record any symptoms that may be related to the vaccine or the injection site in a diary card for 7 days after each vaccination. This multi-centre trial will be conducted in Belgium. The overall time to participate in this study is up to 393 days. Participants will make 6 visits to the clinic, and will be contacted by telephone twice for follow-up assessments.

Interventions

BIOLOGICALHepatitis A Vaccine

Hepatitis A Vaccine IM injection

BIOLOGICALNorovirus Bivalent VLP Vaccine

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

Sponsors

Takeda
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes

Inclusion criteria

1. Male and female participants between 18 and 64 years of age at the time of enrollment. 2. In good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs), and clinical judgment of the investigator. 3. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form 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. 4. Can comply with trial procedures and are available for the duration of the trial.

Exclusion criteria

1. Has received any vaccines containing Hepatitis A vaccine within the past 5 years. 2. Has contraindications, warnings, and/or precautions to vaccination with Havrix as specified within the Summary of Product Characteristics. 3. Has a clinically significant active infection (as assessed by the investigator) or oral body temperature 38°C (100.4°F) or higher within 3 days of the intended date of vaccination. 4. Has received antipyretic/analgesic medications within 24 hours prior to the intended vaccine administration. 5. Known hypersensitivity or allergy to investigational vaccine (including excipients of the investigational vaccine). 6. 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. 7. Has a history of any progressive or severe neurologic disorder, seizure disorder, or Guillain-Barré syndrome. 8. Has history of 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. 9. Known or inspected impairment/alteration of immune function, including the following: 1. Chronic use of oral steroids (Equivalent to 20 mg/day prednisone for ≥12 weeks/≥2 mg/kg body weight/day for ≥2 weeks) within 60 days prior to Day 1 (use of inhaled, intranasal, or topical corticosteroids is allowed). 2. Receipt of parenteral steroids (equivalent to 20 mg/day prednisone ≥12 weeks/≥2 mg/kg body weight/day for ≥2 weeks) within 60 days prior to Day 1. 3. Receipt of immunostimulants within 60 days prior to Day 1. 4. 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. 5. Receipt of immunosuppressive therapy within 6 months prior to Day 1. 6. Human immunodeficiency virus (HIV) infection or HIV-related disease. 7. Heritable immunodeficiency. 10. Abnormalities of splenic or thymic function. 11. Has a known bleeding diathesis or any condition that may be associated with a prolonged bleeding time. 12. Has any serious chronic or progressive disease according to judgment of the investigator (eg, neoplasm, insulin dependent diabetes, cardiac, renal, or hepatic disease). 13. Has a body mass index (BMI) greater than or equal to 35 kg/m\^2 (=weight in kg/\[height in meters \* height in meters\]). 14. 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. 15. Has 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. 16. Is first degree relatives of individuals involved in trial conduct. 17. Has history of substance or alcohol abuse within the past 2 years. 18. If female, of childbearing potential, sexually active, and has not used any of the acceptable contraceptive methods for at least 2 months prior to trial entry. 19. Female participants of childbearing potential and sexually active, who refuse to use an acceptable contraceptive method from Day 1 through 6 months after the last dose of investigational vaccine. 20. Female participants who plan to donate ova from Day 1 through 6 months after the last dose of investigational vaccine. 21. Female participants with any positive pregnancy test. 22. Female participants who are pregnant or breastfeeding.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants With a Seroresponse (Pan-Ig ELISA)Baseline and Day 56Seroresponse 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).
Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Days 1 through 7Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occurred within 7 days after each vaccination.
Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Days 28 through 34Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occurred within 7 days after each vaccination.
Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Days 1 through 7Solicited systemic AEs are defined as: headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea that occurred within 7 days after each vaccination.
Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Days 28 through 34Solicited systemic AEs are defined as: headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea that occurred within 7 days after each vaccination.
Oral Body Temperature Within 7 Days After Dose 1Days 1 through 7Oral 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.
Oral Body Temperature Within 7 Days After Dose 2Days 28 through 34Oral 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.
Percentage of Participants With Unsolicited Adverse Events (AEs)Day 1 up to Day 56Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study.
Percentage of Participants With Serious Adverse Events (SAEs)Day 1 up to Day 393A 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.

Secondary

MeasureTime frameDescription
Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)Baseline and Days 28, 56, 208 and 393The 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 and for selected arms on day 208 and day 393. D=Day
Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)Baseline and Days 28, 56, 208 and 393The 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 and for selected arms on day 208 and day 393. D=Day
Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)Day 1 (Baseline) and Days 28, 56, 208 and 393Geometric 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 and for selected arms on day 208 and day 393. D=Day
Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)Day 1 (Baseline) and Days 28, 56, 208 and 393Geometric 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 and for selected arms on day 208 and day 393. D=Day
Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)Days 28, 56, 208 and 393Geometric 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 and for selected arms on day 208 and day 393. D=Day
Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)Days 28, 56, 208 and 393Geometric 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 and for selected arms on day 208 and day 393. D=Day
Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)Baseline and Days 28, 56, 208 and 393Percentage 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
Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)Baseline and Days 28, 56, 208 and 393The 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
Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)Baseline and Days 28, 56, 208 and 393The 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
Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)Baseline (Day 1) and Days 28, 56, 208 and 393Blocking titers 50 (BT50) of anti-norovirus GI.1 VLP antibody titers as measured by HBGA binding assay. D=Day
Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)Day 1 (Baseline) and Days 28, 56, 208 and 393Blocking titers 50 (BT50) of anti-norovirus GII.4 VLP antibody titers as measured by HBGA binding assay. D=Day
Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)Baseline and Days 28, 208 and 393Seroresponse 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
Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)Days 28, 56, 208 and 393Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by the HBGA binding assay. D=Day
GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)Days 28, 56, 208 and 393GMFR of anti-norovirus GII.4 Cincinnati antibody titers as measured by HBGA binding assay. D=Day
GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)Days 28, 56, 208 and 393GMFR of anti-norovirus GII.4 Sydney antibody titers as measured by HBGA binding assay. D=Day
GMFR of Antibody Titers of Strains Not Represented in the Investigational Vaccine: Cross-Protection AssaysDay 56GMFR 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
Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)Day 1 (Baseline) and Days 28, 56, 208 and 393Blocking titers 50 (BT50) of anti-norovirus GII.4 Cincinnati antibody titers as measured by HBGA binding assay. D=Day
Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GII.2 EC50 (HBGA)Day 1 (Baseline) and Day 56Blocking 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
Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GI.3 EC50 (HBGA)Day 1 (Baseline) and Day 56Blocking 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
Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GII.4.2012 EC50 (HBGA)Day 1 (Baseline) and Day 56Blocking 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
Percentage of Participants With Significant New Medical ConditionsDay 1 up to Day 56Significant 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.
Percentage of Participants With Any Adverse Event (AE) Leading to Withdrawal From the StudyDay 1 up to Day 56Withdrawal 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.
Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)Days 28, 56, 208 and 393Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by HBGA binding assay. D=Day
Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)Baseline and Days 28, 56, 208 and 393The 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
Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)Baseline and Days 28, 56, 208 and 393The 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
Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)Day 1 (Baseline) and Days 28, 56, 208 and 393Geometric mean titer (GMT) of anti-norovirus GI.1 VLP antibody titers as measured by pan-Ig ELISA. D=Day
Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)Day 1 (Baseline) and Days 28, 56, 208 and 393Geometric mean titer (GMT) of anti-norovirus GII.4 VLP antibody titers as measured by pan-Ig ELISA. D=Day
Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)Days 28, 56, 208 and 393Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by pan-Ig ELISA. D=Day
Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)Days 28, 56, 208 and 393Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by pan-Ig ELISA. D=Day
Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)Baseline and Days 28, 56, 208 and 393Percentage 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 and for selected arms on day 208 and day 393. D=Day
Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)Day 1 (Baseline) and Days 28, 56, 208 and 393Blocking Titers 50 (BT50) of anti-norovirus GII.4 Sydney antibody titers as measured by HBGA binding assay. D=Day

Countries

Belgium

Participant flow

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.

Pre-assignment 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.

Participants by arm

ArmCount
GI.1/GII.4 (15/15) - MPL (50)
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.
30
GI.1/GII.4 (15/50) - MPL (50)
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.
30
GI.1/GII.4 (50/50) - MPL (50)
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.
30
GI.1/GII.4 (15/15) - MPL (15)
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.
31
GI.1/GII.4 (15/50) - MPL (15)
IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent 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, on Day 28.
30
GI.1/GII.4 (50/50) - MPL (15)
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.
31
GI.1/GII.4 (15/15)
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.
30
GI.1/GII.4 (15/50)
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.
32
GI.1/GII.4 (50/50)
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.
29
GI.1/GII.4 (50/150)
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.
30
GI.1/GII.4 (15/50) - Al(OH)3 (167)
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.
29
GI.1/GII.4 (15/50) x2
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.
28
GI.1/GII.4 (50/150) x2
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.
29
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
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.
31
Total420

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006FG007FG008FG009FG010FG011FG012FG013
Overall StudyProtocol Violation00000000001000
Overall StudyWithdrawal by Subject00000000001000

Baseline characteristics

CharacteristicGI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/50) x2GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/50) - Al(OH)3 (167) x2GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (15/50) - MPL (50)TotalGI.1/GII.4 (50/150)GI.1/GII.4 (15/50)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/15)GI.1/GII.4 (50/150) x2
Age, Continuous50.0 years
FULL_RANGE 12.95
48.5 years
FULL_RANGE 14.05
50.0 years
FULL_RANGE 14.95
50.0 years
FULL_RANGE 14.7
41.0 years
FULL_RANGE 14.82
50.0 years
FULL_RANGE 14.39
44.0 years
FULL_RANGE 16.11
49.5 years
FULL_RANGE 13.79
51.0 years
FULL_RANGE 14.36
49.5 years51.0 years
FULL_RANGE 15.26
48.5 years
FULL_RANGE 14.13
49.0 years
FULL_RANGE 15.41
49.5 years
FULL_RANGE 14.19
48.0 years
FULL_RANGE 15.06
Age, Customized
18-49 Years
15 participants14 participants15 participants15 participants15 participants15 participants16 participants15 participants14 participants210 participants15 participants16 participants15 participants15 participants15 participants
Age, Customized
50-64 Years
15 participants14 participants16 participants15 participants14 participants16 participants15 participants15 participants16 participants210 participants15 participants16 participants14 participants15 participants14 participants
Body Mass Index (BMI)26.11 kg/m^224.24 kg/m^223.62 kg/m^225.22 kg/m^226.06 kg/m^224.73 kg/m^224.54 kg/m^224.51 kg/m^223.97 kg/m^224.52 kg/m^225.02 kg/m^224.06 kg/m^223.66 kg/m^224.40 kg/m^223.19 kg/m^2
Height166.5 cm171.5 cm167.0 cm173.0 cm171.0 cm169.0 cm175.0 cm171.0 cm167.0 cm170.0 cm167.0 cm169.5 cm172.0 cm173.5 cm170.0 cm
Race/Ethnicity, Customized
American Indian or Alaska Native
0 participants0 participants0 participants0 participants0 participants1 participants0 participants0 participants0 participants1 participants0 participants0 participants0 participants0 participants0 participants
Race/Ethnicity, Customized
Asian
0 participants0 participants1 participants1 participants1 participants1 participants0 participants0 participants0 participants5 participants1 participants0 participants0 participants0 participants0 participants
Race/Ethnicity, Customized
White
30 participants28 participants30 participants29 participants28 participants29 participants31 participants30 participants30 participants414 participants29 participants32 participants29 participants30 participants29 participants
Region of Enrollment
Belgium
30 participants28 participants31 participants30 participants29 participants31 participants31 participants30 participants30 participants420 participants30 participants32 participants29 participants30 participants29 participants
Sex: Female, Male
Female
20 Participants16 Participants22 Participants18 Participants20 Participants23 Participants18 Participants19 Participants20 Participants268 Participants23 Participants18 Participants16 Participants15 Participants20 Participants
Sex: Female, Male
Male
10 Participants12 Participants9 Participants12 Participants9 Participants8 Participants13 Participants11 Participants10 Participants152 Participants7 Participants14 Participants13 Participants15 Participants9 Participants
Weight70.60 kg75.50 kg66.60 kg69.50 kg76.00 kg68.50 kg69.90 kg71.60 kg65.60 kg70.8 kg69.85 kg74.35 kg70.00 kg72.50 kg70.60 kg

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
EG008
affected / at risk
EG009
affected / at risk
EG010
affected / at risk
EG011
affected / at risk
EG012
affected / at risk
EG013
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —— / —— / —— / —— / —— / —— / —— / —— / —— / —— / —
other
Total, other adverse events
10 / 3012 / 307 / 3010 / 319 / 309 / 317 / 3011 / 328 / 296 / 306 / 299 / 288 / 299 / 31
serious
Total, serious adverse events
2 / 300 / 305 / 302 / 311 / 300 / 313 / 303 / 321 / 291 / 301 / 292 / 281 / 291 / 31

Outcome results

Primary

Oral Body Temperature Within 7 Days After Dose 1

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.

Time frame: Days 1 through 7

Population: Safety population included all participants who received at least one dose of trial vaccine.

ArmMeasureValue (MEAN)Dispersion
GI.1/GII.4 (15/15) - MPL (50)Oral Body Temperature Within 7 Days After Dose 136.54 degrees CelsiusStandard Deviation 0.294
GI.1/GII.4 (15/50) - MPL (50)Oral Body Temperature Within 7 Days After Dose 136.76 degrees CelsiusStandard Deviation 0.376
GI.1/GII.4 (50/50) - MPL (50)Oral Body Temperature Within 7 Days After Dose 136.66 degrees CelsiusStandard Deviation 0.345
GI.1/GII.4 (15/15) - MPL (15)Oral Body Temperature Within 7 Days After Dose 136.71 degrees CelsiusStandard Deviation 0.26
GI.1/GII.4 (15/50) - MPL (15)Oral Body Temperature Within 7 Days After Dose 136.65 degrees CelsiusStandard Deviation 0.388
GI.1/GII.4 (50/50) - MPL (15)Oral Body Temperature Within 7 Days After Dose 136.67 degrees CelsiusStandard Deviation 0.255
GI.1/GII.4 (15/15)Oral Body Temperature Within 7 Days After Dose 136.74 degrees CelsiusStandard Deviation 0.323
GI.1/GII.4 (15/50)Oral Body Temperature Within 7 Days After Dose 136.63 degrees CelsiusStandard Deviation 0.366
GI.1/GII.4 (50/50)Oral Body Temperature Within 7 Days After Dose 136.52 degrees CelsiusStandard Deviation 0.405
GI.1/GII.4 (50/150)Oral Body Temperature Within 7 Days After Dose 136.77 degrees CelsiusStandard Deviation 0.341
GI.1/GII.4 (15/50) - Al(OH)3 (167)Oral Body Temperature Within 7 Days After Dose 136.71 degrees CelsiusStandard Deviation 0.404
GI.1/GII.4 (15/50) x2Oral Body Temperature Within 7 Days After Dose 136.61 degrees CelsiusStandard Deviation 0.368
GI.1/GII.4 (50/150) x2Oral Body Temperature Within 7 Days After Dose 136.70 degrees CelsiusStandard Deviation 0.362
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Oral Body Temperature Within 7 Days After Dose 136.61 degrees CelsiusStandard Deviation 0.381
Primary

Oral Body Temperature Within 7 Days After Dose 2

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.

Time frame: Days 28 through 34

Population: Safety population included all participants who received at least one dose of trial vaccine.

ArmMeasureValue (MEAN)Dispersion
GI.1/GII.4 (15/15) - MPL (50)Oral Body Temperature Within 7 Days After Dose 236.54 degrees CelsiusStandard Deviation 0.282
GI.1/GII.4 (15/50) - MPL (50)Oral Body Temperature Within 7 Days After Dose 236.76 degrees CelsiusStandard Deviation 0.301
GI.1/GII.4 (50/50) - MPL (50)Oral Body Temperature Within 7 Days After Dose 236.68 degrees CelsiusStandard Deviation 0.351
GI.1/GII.4 (15/15) - MPL (15)Oral Body Temperature Within 7 Days After Dose 236.75 degrees CelsiusStandard Deviation 0.466
GI.1/GII.4 (15/50) - MPL (15)Oral Body Temperature Within 7 Days After Dose 236.60 degrees CelsiusStandard Deviation 0.286
GI.1/GII.4 (50/50) - MPL (15)Oral Body Temperature Within 7 Days After Dose 236.72 degrees CelsiusStandard Deviation 0.317
GI.1/GII.4 (15/15)Oral Body Temperature Within 7 Days After Dose 236.71 degrees CelsiusStandard Deviation 0.394
GI.1/GII.4 (15/50)Oral Body Temperature Within 7 Days After Dose 236.64 degrees CelsiusStandard Deviation 0.342
GI.1/GII.4 (50/50)Oral Body Temperature Within 7 Days After Dose 236.59 degrees CelsiusStandard Deviation 0.463
GI.1/GII.4 (50/150)Oral Body Temperature Within 7 Days After Dose 236.73 degrees CelsiusStandard Deviation 0.293
GI.1/GII.4 (15/50) - Al(OH)3 (167)Oral Body Temperature Within 7 Days After Dose 236.68 degrees CelsiusStandard Deviation 0.345
GI.1/GII.4 (15/50) x2Oral Body Temperature Within 7 Days After Dose 236.56 degrees CelsiusStandard Deviation 0.351
GI.1/GII.4 (50/150) x2Oral Body Temperature Within 7 Days After Dose 236.76 degrees CelsiusStandard Deviation 0.391
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Oral Body Temperature Within 7 Days After Dose 236.61 degrees CelsiusStandard Deviation 0.386
Primary

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

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).

Time frame: Baseline and Day 56

Population: Full Analysis Set included all randomized participants who received at least one dose of trial vaccine.

ArmMeasureValue (NUMBER)
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With a Seroresponse (Pan-Ig ELISA)43.3 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With a Seroresponse (Pan-Ig ELISA)62.1 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With a Seroresponse (Pan-Ig ELISA)46.4 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With a Seroresponse (Pan-Ig ELISA)35.5 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With a Seroresponse (Pan-Ig ELISA)80.0 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With a Seroresponse (Pan-Ig ELISA)67.7 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With a Seroresponse (Pan-Ig ELISA)30.0 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With a Seroresponse (Pan-Ig ELISA)62.5 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With a Seroresponse (Pan-Ig ELISA)42.9 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With a Seroresponse (Pan-Ig ELISA)66.7 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With a Seroresponse (Pan-Ig ELISA)46.2 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With a Seroresponse (Pan-Ig ELISA)71.4 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With a Seroresponse (Pan-Ig ELISA)69.0 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With a Seroresponse (Pan-Ig ELISA)56.7 percentage of participants
Primary

Percentage of Participants With Serious Adverse Events (SAEs)

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.

Time frame: Day 1 up to Day 393

Population: Safety population included all participants who received at least one dose of trial vaccine.

ArmMeasureValue (NUMBER)
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With Serious Adverse Events (SAEs)6.7 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With Serious Adverse Events (SAEs)0 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With Serious Adverse Events (SAEs)16.7 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With Serious Adverse Events (SAEs)6.5 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With Serious Adverse Events (SAEs)3.3 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With Serious Adverse Events (SAEs)0 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With Serious Adverse Events (SAEs)10.0 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With Serious Adverse Events (SAEs)9.4 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With Serious Adverse Events (SAEs)3.4 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With Serious Adverse Events (SAEs)3.3 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With Serious Adverse Events (SAEs)3.4 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With Serious Adverse Events (SAEs)7.1 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With Serious Adverse Events (SAEs)3.4 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With Serious Adverse Events (SAEs)3.2 percentage of participants
Primary

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

Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occurred within 7 days after each vaccination.

Time frame: Days 1 through 7

Population: Safety population included all participants who received at least one dose of trial vaccine.

ArmMeasureGroupValue (NUMBER)
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Swelling0 percentage of participants
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Pain43.3 percentage of participants
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Induration0 percentage of participants
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Erythema0 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Erythema0 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Induration0 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Swelling0 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Pain33.3 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Erythema0 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Swelling0 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Induration0 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Pain50.0 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Induration0 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Swelling0 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Pain32.3 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Erythema0 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Induration0 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Swelling0 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Pain46.7 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Erythema0 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Pain38.7 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Swelling0 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Erythema0 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Induration0 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Erythema0 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Pain40.0 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Induration0 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Swelling0 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Induration0 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Pain53.1 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Erythema0 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Swelling0 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Erythema0 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Induration0 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Pain44.8 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Swelling3.4 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Swelling0 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Induration0 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Pain53.3 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Erythema0 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Pain48.3 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Swelling0 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Induration0 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Erythema0 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Erythema0 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Swelling0 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Pain46.4 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Induration0 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Erythema0 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Induration0 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Pain31.0 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Swelling0 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Induration0 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Pain32.3 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Erythema0 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1Swelling0 percentage of participants
Primary

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

Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occurred within 7 days after each vaccination.

Time frame: Days 28 through 34

Population: Safety population included all participants who received at least one dose of trial vaccine.

ArmMeasureGroupValue (NUMBER)
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Induration0 percentage of participants
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Swelling0 percentage of participants
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Pain60.0 percentage of participants
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Erythema0 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Pain36.7 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Induration0 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Erythema0 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Swelling3.3 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Erythema3.3 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Swelling0 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Pain66.7 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Induration3.3 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Pain51.6 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Swelling3.2 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Erythema0 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Induration0 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Swelling0 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Pain53.3 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Erythema0 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Induration6.7 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Erythema0 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Pain58.1 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Induration0 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Swelling3.2 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Induration0 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Swelling0 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Erythema0 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Pain33.3 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Pain43.8 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Induration0 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Erythema0 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Swelling0 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Induration3.4 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Swelling6.9 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Pain48.3 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Erythema3.4 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Swelling0 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Erythema3.3 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Induration3.3 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Pain46.7 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Swelling0 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Induration0 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Erythema0 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Pain34.5 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Swelling0 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Induration0 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Erythema0 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Pain32.1 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Pain41.4 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Erythema0 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Swelling0 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Induration0 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Swelling0 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Induration0 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Pain35.5 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2Erythema0 percentage of participants
Primary

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

Solicited systemic AEs are defined as: headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea that occurred within 7 days after each vaccination.

Time frame: Days 1 through 7

Population: Safety population included all participants who received at least one dose of trial vaccine.

ArmMeasureGroupValue (NUMBER)
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Diarrhea0 percentage of participants
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Arthralgia0 percentage of participants
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Headache20.0 percentage of participants
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Myalgia20.0 percentage of participants
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Vomiting0 percentage of participants
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Fatigue23.3 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Myalgia6.7 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Vomiting3.3 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Diarrhea23.3 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Fatigue23.3 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Headache26.7 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Arthralgia3.3 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Arthralgia6.7 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Headache3.3 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Diarrhea3.3 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Fatigue16.7 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Vomiting0 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Myalgia13.3 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Fatigue19.4 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Arthralgia0 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Headache19.4 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Diarrhea16.1 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Vomiting0 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Myalgia6.5 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Diarrhea20.0 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Vomiting0 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Fatigue10.0 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Arthralgia3.3 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Headache16.7 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Myalgia3.3 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Headache12.9 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Fatigue12.9 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Diarrhea6.5 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Myalgia9.7 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Vomiting3.2 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Arthralgia0 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Fatigue13.3 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Headache13.3 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Myalgia6.7 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Arthralgia3.3 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Vomiting0 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Diarrhea13.3 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Vomiting0 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Fatigue15.6 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Myalgia18.8 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Diarrhea12.5 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Headache25.0 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Arthralgia6.3 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Headache27.6 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Vomiting0 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Fatigue17.2 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Arthralgia6.9 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Diarrhea13.8 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Myalgia10.3 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Headache20.0 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Myalgia10.0 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Arthralgia3.3 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Fatigue20.0 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Vomiting3.3 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Diarrhea10.0 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Vomiting3.4 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Diarrhea6.9 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Headache13.8 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Arthralgia3.4 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Fatigue24.1 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Myalgia17.2 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Fatigue25.0 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Arthralgia3.6 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Vomiting0 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Headache17.9 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Diarrhea7.1 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Myalgia10.7 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Myalgia3.4 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Arthralgia3.4 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Diarrhea10.3 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Fatigue17.2 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Headache31.0 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Vomiting0 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Headache19.4 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Arthralgia3.2 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Diarrhea12.9 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Fatigue22.6 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Myalgia19.4 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1Vomiting0 percentage of participants
Primary

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

Solicited systemic AEs are defined as: headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea that occurred within 7 days after each vaccination.

Time frame: Days 28 through 34

Population: Safety population included all participants who received at least one dose of trial vaccine.

ArmMeasureGroupValue (NUMBER)
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Myalgia13.3 percentage of participants
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Vomiting0 percentage of participants
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Arthralgia0 percentage of participants
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Diarrhea3.3 percentage of participants
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Fatigue16.7 percentage of participants
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Headache13.3 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Diarrhea10.0 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Vomiting0 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Fatigue13.3 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Headache13.3 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Myalgia3.3 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Arthralgia3.3 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Arthralgia3.3 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Diarrhea16.7 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Myalgia13.3 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Fatigue20.0 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Headache13.3 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Vomiting0 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Vomiting0 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Arthralgia0 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Diarrhea12.9 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Headache22.6 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Myalgia0 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Fatigue12.9 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Arthralgia3.3 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Headache23.3 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Diarrhea16.7 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Fatigue10.0 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Vomiting0 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Myalgia13.3 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Fatigue12.9 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Diarrhea9.7 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Headache16.1 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Myalgia12.9 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Arthralgia3.2 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Vomiting0 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Myalgia0 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Fatigue10.0 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Vomiting0 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Diarrhea6.7 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Headache10.0 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Arthralgia0 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Vomiting0 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Headache21.9 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Fatigue18.8 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Myalgia6.3 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Arthralgia3.1 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Diarrhea15.6 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Vomiting0 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Arthralgia0 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Diarrhea17.2 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Myalgia6.9 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Headache20.7 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Fatigue17.2 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Arthralgia3.3 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Diarrhea10.0 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Fatigue13.3 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Vomiting3.3 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Headache10.0 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Myalgia0 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Arthralgia3.4 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Myalgia10.3 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Vomiting3.4 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Fatigue13.8 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Diarrhea3.4 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Headache13.8 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Myalgia7.1 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Arthralgia3.6 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Fatigue7.1 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Vomiting0 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Headache14.3 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Diarrhea7.1 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Fatigue13.8 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Vomiting0 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Arthralgia0 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Diarrhea6.9 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Myalgia0 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Headache34.5 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Headache19.4 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Myalgia6.5 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Fatigue12.9 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Diarrhea3.2 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Arthralgia3.2 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2Vomiting0 percentage of participants
Primary

Percentage of Participants With Unsolicited Adverse Events (AEs)

Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study.

Time frame: Day 1 up to Day 56

Population: Safety population included all participants who received at least one dose of trial vaccine.

ArmMeasureValue (NUMBER)
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With Unsolicited Adverse Events (AEs)56.7 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With Unsolicited Adverse Events (AEs)60.0 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With Unsolicited Adverse Events (AEs)53.3 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With Unsolicited Adverse Events (AEs)45.2 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With Unsolicited Adverse Events (AEs)43.3 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With Unsolicited Adverse Events (AEs)54.8 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With Unsolicited Adverse Events (AEs)43.3 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With Unsolicited Adverse Events (AEs)62.5 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With Unsolicited Adverse Events (AEs)69.0 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With Unsolicited Adverse Events (AEs)43.3 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With Unsolicited Adverse Events (AEs)48.3 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With Unsolicited Adverse Events (AEs)50.0 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With Unsolicited Adverse Events (AEs)51.7 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With Unsolicited Adverse Events (AEs)61.3 percentage of participants
Secondary

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

Blocking titers 50 (BT50) of anti-norovirus GI.1 VLP antibody titers as measured by HBGA binding assay. D=Day

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

Population: 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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
GI.1/GII.4 (15/15) - MPL (50)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)280.5 titerStandard Deviation 3.94
GI.1/GII.4 (15/15) - MPL (50)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)25.0 titerStandard Deviation 2.6
GI.1/GII.4 (15/15) - MPL (50)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)24.8 titerStandard Deviation 2.75
GI.1/GII.4 (15/15) - MPL (50)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)130.0 titerStandard Deviation 3.38
GI.1/GII.4 (15/15) - MPL (50)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)67.8 titerStandard Deviation 3.78
GI.1/GII.4 (15/50) - MPL (50)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)18.6 titerStandard Deviation 1.86
GI.1/GII.4 (15/50) - MPL (50)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)98.2 titerStandard Deviation 3.46
GI.1/GII.4 (15/50) - MPL (50)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)51.3 titerStandard Deviation 3.23
GI.1/GII.4 (15/50) - MPL (50)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)18.7 titerStandard Deviation 1.85
GI.1/GII.4 (15/50) - MPL (50)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)236.3 titerStandard Deviation 4.61
GI.1/GII.4 (50/50) - MPL (50)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)403.3 titerStandard Deviation 3.74
GI.1/GII.4 (50/50) - MPL (50)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)88.1 titerStandard Deviation 3.54
GI.1/GII.4 (50/50) - MPL (50)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)26.0 titerStandard Deviation 2.73
GI.1/GII.4 (50/50) - MPL (50)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)159.0 titerStandard Deviation 3.23
GI.1/GII.4 (50/50) - MPL (50)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)23.8 titerStandard Deviation 2.44
GI.1/GII.4 (15/15) - MPL (15)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)74.8 titerStandard Deviation 4.26
GI.1/GII.4 (15/15) - MPL (15)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)286.9 titerStandard Deviation 5.01
GI.1/GII.4 (15/15) - MPL (15)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)26.8 titerStandard Deviation 3.35
GI.1/GII.4 (15/15) - MPL (15)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)26.7 titerStandard Deviation 3.19
GI.1/GII.4 (15/15) - MPL (15)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)136.4 titerStandard Deviation 3.67
GI.1/GII.4 (15/50) - MPL (15)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)22.86 titerStandard Deviation 3.94
GI.1/GII.4 (15/50) - MPL (15)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)80.1 titerStandard Deviation 3.49
GI.1/GII.4 (15/50) - MPL (15)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)44.0 titerStandard Deviation 3.39
GI.1/GII.4 (15/50) - MPL (15)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)19.1 titerStandard Deviation 1.68
GI.1/GII.4 (15/50) - MPL (15)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)18.6 titerStandard Deviation 1.7
GI.1/GII.4 (50/50) - MPL (15)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)24.8 titerStandard Deviation 2.31
GI.1/GII.4 (50/50) - MPL (15)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)71.9 titerStandard Deviation 3.4
GI.1/GII.4 (50/50) - MPL (15)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)23.0 titerStandard Deviation 2.24
GI.1/GII.4 (50/50) - MPL (15)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)356.4 titerStandard Deviation 3.74
GI.1/GII.4 (50/50) - MPL (15)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)139.3 titerStandard Deviation 2.68
GI.1/GII.4 (15/15)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)159.8 titerStandard Deviation 2.73
GI.1/GII.4 (15/15)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)30.5 titerStandard Deviation 3.04
GI.1/GII.4 (15/15)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)91.5 titerStandard Deviation 3.14
GI.1/GII.4 (15/15)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)400.1 titerStandard Deviation 3.33
GI.1/GII.4 (15/15)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)27.3 titerStandard Deviation 2.46
GI.1/GII.4 (15/50)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)412.9 titerStandard Deviation 4.78
GI.1/GII.4 (15/50)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)24.5 titerStandard Deviation 2.59
GI.1/GII.4 (15/50)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)107.5 titerStandard Deviation 3.97
GI.1/GII.4 (15/50)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)202.1 titerStandard Deviation 3.34
GI.1/GII.4 (15/50)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)25.1 titerStandard Deviation 2.52
GI.1/GII.4 (50/50)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)208.6 titerStandard Deviation 3.28
GI.1/GII.4 (50/50)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)99.6 titerStandard Deviation 4.09
GI.1/GII.4 (50/50)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)23.8 titerStandard Deviation 2.46
GI.1/GII.4 (50/50)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)25.5 titerStandard Deviation 2.52
GI.1/GII.4 (50/50)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)510.0 titerStandard Deviation 4.36
GI.1/GII.4 (50/150)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)23.2 titerStandard Deviation 2.19
GI.1/GII.4 (50/150)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)114.5 titerStandard Deviation 2.89
GI.1/GII.4 (50/150)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)247.2 titerStandard Deviation 3.43
GI.1/GII.4 (50/150)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)24.8 titerStandard Deviation 2.37
GI.1/GII.4 (50/150)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)55.0 titerStandard Deviation 3.22
GI.1/GII.4 (15/50) - Al(OH)3 (167)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)271.3 titerStandard Deviation 5
GI.1/GII.4 (15/50) - Al(OH)3 (167)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)66.1 titerStandard Deviation 3.86
GI.1/GII.4 (15/50) - Al(OH)3 (167)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)26.3 titerStandard Deviation 2.68
GI.1/GII.4 (15/50) - Al(OH)3 (167)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)28.5 titerStandard Deviation 2.66
GI.1/GII.4 (15/50) - Al(OH)3 (167)Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)107.9 titerStandard Deviation 3.28
GI.1/GII.4 (15/50) x2Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)103.4 titerStandard Deviation 3.95
GI.1/GII.4 (15/50) x2Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)347.6 titerStandard Deviation 4.62
GI.1/GII.4 (15/50) x2Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)398.6 titerStandard Deviation 2.7
GI.1/GII.4 (15/50) x2Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)23.1 titerStandard Deviation 2.25
GI.1/GII.4 (15/50) x2Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)196.4 titerStandard Deviation 2.86
GI.1/GII.4 (50/150) x2Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)385.9 titerStandard Deviation 3.64
GI.1/GII.4 (50/150) x2Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)113.6 titerStandard Deviation 3.3
GI.1/GII.4 (50/150) x2Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)463.5 titerStandard Deviation 2.32
GI.1/GII.4 (50/150) x2Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)22.3 titerStandard Deviation 2.26
GI.1/GII.4 (50/150) x2Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)219.2 titerStandard Deviation 2.29
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)182.0 titerStandard Deviation 2.4
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)391.1 titerStandard Deviation 3.56
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)355.8 titerStandard Deviation 2.58
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)20.6 titerStandard Deviation 2.04
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)81.0 titerStandard Deviation 2.85
Secondary

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

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

Time frame: Day 1 (Baseline) and Day 56

Population: 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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
GI.1/GII.4 (15/15) - MPL (50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GI.3 EC50 (HBGA)Day 159.7 titerStandard Deviation 2.98
GI.1/GII.4 (15/15) - MPL (50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GI.3 EC50 (HBGA)Day 56350.5 titerStandard Deviation 3.05
GI.1/GII.4 (15/50) - MPL (50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GI.3 EC50 (HBGA)Day 174.1 titerStandard Deviation 3.7
GI.1/GII.4 (15/50) - MPL (50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GI.3 EC50 (HBGA)Day 56222.7 titerStandard Deviation 5.09
Secondary

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

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

Time frame: Day 1 (Baseline) and Day 56

Population: 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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
GI.1/GII.4 (15/15) - MPL (50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GII.2 EC50 (HBGA)Day 1266.2 titerStandard Deviation 2.62
GI.1/GII.4 (15/15) - MPL (50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GII.2 EC50 (HBGA)Day 56295.8 titerStandard Deviation 2.31
GI.1/GII.4 (15/50) - MPL (50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GII.2 EC50 (HBGA)Day 1265.5 titerStandard Deviation 4.79
GI.1/GII.4 (15/50) - MPL (50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GII.2 EC50 (HBGA)Day 56216.5 titerStandard Deviation 4.46
Secondary

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

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

Time frame: Day 1 (Baseline) and Day 56

Population: 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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
GI.1/GII.4 (15/15) - MPL (50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GII.4.2012 EC50 (HBGA)Day 145.5 titerStandard Deviation 4.07
GI.1/GII.4 (15/15) - MPL (50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GII.4.2012 EC50 (HBGA)Day 56146.6 titerStandard Deviation 3.11
GI.1/GII.4 (15/50) - MPL (50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GII.4.2012 EC50 (HBGA)Day 150.7 titerStandard Deviation 5.1
GI.1/GII.4 (15/50) - MPL (50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GII.4.2012 EC50 (HBGA)Day 56208.5 titerStandard Deviation 3.8
Secondary

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

Blocking titers 50 (BT50) of anti-norovirus GII.4 Cincinnati antibody titers as measured by HBGA binding assay. D=Day

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

Population: 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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
GI.1/GII.4 (15/15) - MPL (50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D1 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)63.7 titerStandard Deviation 4.34
GI.1/GII.4 (15/15) - MPL (50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)217.3 titerStandard Deviation 3.57
GI.1/GII.4 (15/15) - MPL (50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)63.6 titerStandard Deviation 4.31
GI.1/GII.4 (15/15) - MPL (50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/15) - MPL (50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) - MPL (50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D1 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)75.1 titerStandard Deviation 3.85
GI.1/GII.4 (15/50) - MPL (50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) - MPL (50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)380.7 titerStandard Deviation 3.61
GI.1/GII.4 (15/50) - MPL (50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)72.9 titerStandard Deviation 3.95
GI.1/GII.4 (15/50) - MPL (50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/50) - MPL (50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D1 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)114.7 titerStandard Deviation 4.28
GI.1/GII.4 (50/50) - MPL (50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)200.3 titerStandard Deviation 4.33
GI.1/GII.4 (50/50) - MPL (50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/50) - MPL (50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)113.8 titerStandard Deviation 4.02
GI.1/GII.4 (50/50) - MPL (50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/15) - MPL (15)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)83.3 titerStandard Deviation 4.05
GI.1/GII.4 (15/15) - MPL (15)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D1 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)85.8 titerStandard Deviation 4.19
GI.1/GII.4 (15/15) - MPL (15)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/15) - MPL (15)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/15) - MPL (15)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)221.0 titerStandard Deviation 3.66
GI.1/GII.4 (15/50) - MPL (15)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D1 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)63.0 titerStandard Deviation 4.08
GI.1/GII.4 (15/50) - MPL (15)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)263.7 titerStandard Deviation 5.77
GI.1/GII.4 (15/50) - MPL (15)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)61.7 titerStandard Deviation 4.04
GI.1/GII.4 (15/50) - MPL (15)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)113.5 titerStandard Deviation 5.03
GI.1/GII.4 (15/50) - MPL (15)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)88.9 titerStandard Deviation 3.9
GI.1/GII.4 (50/50) - MPL (15)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D1 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)89.1 titerStandard Deviation 4.13
GI.1/GII.4 (50/50) - MPL (15)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/50) - MPL (15)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)327.5 titerStandard Deviation 4.12
GI.1/GII.4 (50/50) - MPL (15)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/50) - MPL (15)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)84.4 titerStandard Deviation 4.23
GI.1/GII.4 (15/15)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/15)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/15)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)90.5 titerStandard Deviation 4.16
GI.1/GII.4 (15/15)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D1 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)99.8 titerStandard Deviation 4.47
GI.1/GII.4 (15/15)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)161.5 titerStandard Deviation 4.66
GI.1/GII.4 (15/50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)501.4 titerStandard Deviation 5.07
GI.1/GII.4 (15/50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D1 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)85.0 titerStandard Deviation 4.64
GI.1/GII.4 (15/50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)88.0 titerStandard Deviation 5.49
GI.1/GII.4 (15/50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)202.5 titerStandard Deviation 4.06
GI.1/GII.4 (15/50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)160.8 titerStandard Deviation 3.96
GI.1/GII.4 (50/50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D1 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)91.8 titerStandard Deviation 4.02
GI.1/GII.4 (50/50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)78.6 titerStandard Deviation 4.06
GI.1/GII.4 (50/50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)248.5 titerStandard Deviation 4.56
GI.1/GII.4 (50/150)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)109.0 titerStandard Deviation 3.25
GI.1/GII.4 (50/150)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/150)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)518.8 titerStandard Deviation 3.4
GI.1/GII.4 (50/150)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/150)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D1 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)112.6 titerStandard Deviation 3.26
GI.1/GII.4 (15/50) - Al(OH)3 (167)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D1 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)134.8 titerStandard Deviation 3.07
GI.1/GII.4 (15/50) - Al(OH)3 (167)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)130.6 titerStandard Deviation 2.95
GI.1/GII.4 (15/50) - Al(OH)3 (167)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) - Al(OH)3 (167)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) - Al(OH)3 (167)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)415.5 titerStandard Deviation 4.11
GI.1/GII.4 (15/50) x2Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) x2Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)248.3 titerStandard Deviation 4.01
GI.1/GII.4 (15/50) x2Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D1 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)54.0 titerStandard Deviation 3.95
GI.1/GII.4 (15/50) x2Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) x2Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)400.0 titerStandard Deviation 3.57
GI.1/GII.4 (50/150) x2Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)296.5 titerStandard Deviation 4.12
GI.1/GII.4 (50/150) x2Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)366.9 titerStandard Deviation 4.6
GI.1/GII.4 (50/150) x2Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/150) x2Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/150) x2Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D1 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)81.8 titerStandard Deviation 3.86
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D1 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)93.2 titerStandard Deviation 3.75
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)534.2 titerStandard Deviation 3.17
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)373.4 titerStandard Deviation 3.4
Secondary

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

Blocking Titers 50 (BT50) of anti-norovirus GII.4 Sydney antibody titers as measured by HBGA binding assay. D=Day

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

Population: 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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
GI.1/GII.4 (15/15) - MPL (50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D1 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)35.0 titerStandard Deviation 3.86
GI.1/GII.4 (15/15) - MPL (50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)53.5 titerStandard Deviation 3.93
GI.1/GII.4 (15/15) - MPL (50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)32.6 titerStandard Deviation 3.49
GI.1/GII.4 (15/15) - MPL (50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/15) - MPL (50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) - MPL (50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D1 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)26.0 titerStandard Deviation 2.3
GI.1/GII.4 (15/50) - MPL (50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) - MPL (50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)59.3 titerStandard Deviation 2.79
GI.1/GII.4 (15/50) - MPL (50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)24.8 titerStandard Deviation 2.29
GI.1/GII.4 (15/50) - MPL (50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/50) - MPL (50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D1 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)43.3 titerStandard Deviation 3.29
GI.1/GII.4 (50/50) - MPL (50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)56.7 titerStandard Deviation 3.06
GI.1/GII.4 (50/50) - MPL (50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/50) - MPL (50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)42.5 titerStandard Deviation 3.1
GI.1/GII.4 (50/50) - MPL (50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/15) - MPL (15)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)31.1 titerStandard Deviation 3.12
GI.1/GII.4 (15/15) - MPL (15)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D1 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)32.4 titerStandard Deviation 3.24
GI.1/GII.4 (15/15) - MPL (15)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/15) - MPL (15)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/15) - MPL (15)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)40.6 titerStandard Deviation 3.37
GI.1/GII.4 (15/50) - MPL (15)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D1 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)28.3 titerStandard Deviation 2.45
GI.1/GII.4 (15/50) - MPL (15)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)55.5 titerStandard Deviation 3.33
GI.1/GII.4 (15/50) - MPL (15)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)26.4 titerStandard Deviation 2.44
GI.1/GII.4 (15/50) - MPL (15)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)40.2 titerStandard Deviation 3.14
GI.1/GII.4 (15/50) - MPL (15)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)28.5 titerStandard Deviation 2.37
GI.1/GII.4 (50/50) - MPL (15)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D1 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)37.5 titerStandard Deviation 3.18
GI.1/GII.4 (50/50) - MPL (15)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/50) - MPL (15)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)62.1 titerStandard Deviation 3.26
GI.1/GII.4 (50/50) - MPL (15)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/50) - MPL (15)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)36.3 titerStandard Deviation 3.09
GI.1/GII.4 (15/15)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/15)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/15)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)25.9 titerStandard Deviation 3.08
GI.1/GII.4 (15/15)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D1 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)29.7 titerStandard Deviation 3.34
GI.1/GII.4 (15/15)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)31.2 titerStandard Deviation 3.04
GI.1/GII.4 (15/50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)80.6 titerStandard Deviation 4.37
GI.1/GII.4 (15/50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D1 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)28.0 titerStandard Deviation 2.93
GI.1/GII.4 (15/50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)30.2 titerStandard Deviation 3.87
GI.1/GII.4 (15/50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)44.2 titerStandard Deviation 3.17
GI.1/GII.4 (15/50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)38.3 titerStandard Deviation 2.87
GI.1/GII.4 (50/50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D1 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)32.2 titerStandard Deviation 3.09
GI.1/GII.4 (50/50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)32.9 titerStandard Deviation 3.09
GI.1/GII.4 (50/50)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)51.2 titerStandard Deviation 3.31
GI.1/GII.4 (50/150)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)27.8 titerStandard Deviation 2.28
GI.1/GII.4 (50/150)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/150)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)70.4 titerStandard Deviation 3.22
GI.1/GII.4 (50/150)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/150)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D1 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)28.1 titerStandard Deviation 2.31
GI.1/GII.4 (15/50) - Al(OH)3 (167)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D1 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)32.3 titerStandard Deviation 2.79
GI.1/GII.4 (15/50) - Al(OH)3 (167)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)31.8 titerStandard Deviation 2.73
GI.1/GII.4 (15/50) - Al(OH)3 (167)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) - Al(OH)3 (167)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) - Al(OH)3 (167)Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)64.4 titerStandard Deviation 3.52
GI.1/GII.4 (15/50) x2Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) x2Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)38.8 titerStandard Deviation 2.98
GI.1/GII.4 (15/50) x2Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D1 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)21.6 titerStandard Deviation 2.11
GI.1/GII.4 (15/50) x2Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) x2Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)48.0 titerStandard Deviation 3.37
GI.1/GII.4 (50/150) x2Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)56.7 titerStandard Deviation 3.15
GI.1/GII.4 (50/150) x2Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)75.1 titerStandard Deviation 3.35
GI.1/GII.4 (50/150) x2Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/150) x2Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/150) x2Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D1 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)29.7 titerStandard Deviation 2.48
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D1 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)37.3 titerStandard Deviation 3.42
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)104.8 titerStandard Deviation 3.35
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)79.1 titerStandard Deviation 3.18
Secondary

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

Blocking titers 50 (BT50) of anti-norovirus GII.4 VLP antibody titers as measured by HBGA binding assay. D=Day

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

Population: 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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
GI.1/GII.4 (15/15) - MPL (50)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,28)120.5 titerStandard Deviation 4.21
GI.1/GII.4 (15/15) - MPL (50)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)336.9 titerStandard Deviation 3.4
GI.1/GII.4 (15/15) - MPL (50)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)66.0 titerStandard Deviation 4.85
GI.1/GII.4 (15/15) - MPL (50)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)69.3 titerStandard Deviation 4.56
GI.1/GII.4 (15/15) - MPL (50)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)186.7 titerStandard Deviation 3.19
GI.1/GII.4 (15/50) - MPL (50)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)75.7 titerStandard Deviation 3.63
GI.1/GII.4 (15/50) - MPL (50)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)241.5 titerStandard Deviation 3.24
GI.1/GII.4 (15/50) - MPL (50)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)80.1 titerStandard Deviation 3.44
GI.1/GII.4 (15/50) - MPL (50)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)686.3 titerStandard Deviation 3.47
GI.1/GII.4 (15/50) - MPL (50)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,28)180.2 titerStandard Deviation 3.95
GI.1/GII.4 (50/50) - MPL (50)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)115.3 titerStandard Deviation 4.24
GI.1/GII.4 (50/50) - MPL (50)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,28)123.5 titerStandard Deviation 3.87
GI.1/GII.4 (50/50) - MPL (50)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)244.6 titerStandard Deviation 2.78
GI.1/GII.4 (50/50) - MPL (50)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)429.0 titerStandard Deviation 2.4
GI.1/GII.4 (50/50) - MPL (50)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)124.9 titerStandard Deviation 3.98
GI.1/GII.4 (15/15) - MPL (15)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)317.8 titerStandard Deviation 2.94
GI.1/GII.4 (15/15) - MPL (15)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,28)133.2 titerStandard Deviation 3.81
GI.1/GII.4 (15/15) - MPL (15)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)91.4 titerStandard Deviation 4.15
GI.1/GII.4 (15/15) - MPL (15)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)87.9 titerStandard Deviation 3.75
GI.1/GII.4 (15/15) - MPL (15)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)206.3 titerStandard Deviation 2.84
GI.1/GII.4 (15/50) - MPL (15)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)60.9 titerStandard Deviation 3.84
GI.1/GII.4 (15/50) - MPL (15)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)67.7 titerStandard Deviation 3.76
GI.1/GII.4 (15/50) - MPL (15)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)675.7 titerStandard Deviation 3.21
GI.1/GII.4 (15/50) - MPL (15)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)229.9 titerStandard Deviation 3.6
GI.1/GII.4 (15/50) - MPL (15)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,28)104.7 titerStandard Deviation 4.01
GI.1/GII.4 (50/50) - MPL (15)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)632.1 titerStandard Deviation 2.11
GI.1/GII.4 (50/50) - MPL (15)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)94.5 titerStandard Deviation 4.3
GI.1/GII.4 (50/50) - MPL (15)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)259.7 titerStandard Deviation 2.66
GI.1/GII.4 (50/50) - MPL (15)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)96.6 titerStandard Deviation 4.03
GI.1/GII.4 (50/50) - MPL (15)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,28)134.4 titerStandard Deviation 3.74
GI.1/GII.4 (15/15)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)80.7 titerStandard Deviation 4.48
GI.1/GII.4 (15/15)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)142.5 titerStandard Deviation 4.09
GI.1/GII.4 (15/15)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)74.6 titerStandard Deviation 4.17
GI.1/GII.4 (15/15)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)189.2 titerStandard Deviation 4.63
GI.1/GII.4 (15/15)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,28)109.3 titerStandard Deviation 4.44
GI.1/GII.4 (15/50)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)346.8 titerStandard Deviation 2.92
GI.1/GII.4 (15/50)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,28)182.9 titerStandard Deviation 3.6
GI.1/GII.4 (15/50)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)89.8 titerStandard Deviation 4.41
GI.1/GII.4 (15/50)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)98.1 titerStandard Deviation 5.11
GI.1/GII.4 (15/50)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)842.8 titerStandard Deviation 3.23
GI.1/GII.4 (50/50)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)201.0 titerStandard Deviation 3.49
GI.1/GII.4 (50/50)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)360.1 titerStandard Deviation 3.85
GI.1/GII.4 (50/50)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,28)121.9 titerStandard Deviation 3.88
GI.1/GII.4 (50/50)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)96.2 titerStandard Deviation 3.93
GI.1/GII.4 (50/50)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)92.9 titerStandard Deviation 3.87
GI.1/GII.4 (50/150)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)123.3 titerStandard Deviation 3.25
GI.1/GII.4 (50/150)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,28)179.7 titerStandard Deviation 2.53
GI.1/GII.4 (50/150)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)102.3 titerStandard Deviation 3.39
GI.1/GII.4 (50/150)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)862.8 titerStandard Deviation 3.12
GI.1/GII.4 (50/150)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)340.6 titerStandard Deviation 2.6
GI.1/GII.4 (15/50) - Al(OH)3 (167)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)324.6 titerStandard Deviation 3.07
GI.1/GII.4 (15/50) - Al(OH)3 (167)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)117.6 titerStandard Deviation 3.62
GI.1/GII.4 (15/50) - Al(OH)3 (167)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)121.9 titerStandard Deviation 3.47
GI.1/GII.4 (15/50) - Al(OH)3 (167)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,28)209.0 titerStandard Deviation 3.38
GI.1/GII.4 (15/50) - Al(OH)3 (167)Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)778.0 titerStandard Deviation 2.57
GI.1/GII.4 (15/50) x2Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)277.5 titerStandard Deviation 2.53
GI.1/GII.4 (15/50) x2Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)56.1 titerStandard Deviation 3.48
GI.1/GII.4 (15/50) x2Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)552.6 titerStandard Deviation 3.65
GI.1/GII.4 (15/50) x2Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)426.5 titerStandard Deviation 3.46
GI.1/GII.4 (15/50) x2Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,28)126.2 titerStandard Deviation 3.56
GI.1/GII.4 (50/150) x2Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)596.3 titerStandard Deviation 2.86
GI.1/GII.4 (50/150) x2Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)92.0 titerStandard Deviation 3.96
GI.1/GII.4 (50/150) x2Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)688.4 titerStandard Deviation 3.16
GI.1/GII.4 (50/150) x2Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,28)171.2 titerStandard Deviation 3.61
GI.1/GII.4 (50/150) x2Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)350.9 titerStandard Deviation 2.36
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)295.3 titerStandard Deviation 3.07
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)604.4 titerStandard Deviation 2.91
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)904.4 titerStandard Deviation 2.67
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)117.8 titerStandard Deviation 3.91
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,28)192.9 titerStandard Deviation 3.52
Secondary

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

Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by HBGA binding assay. D=Day

Time frame: Days 28, 56, 208 and 393

Population: 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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
GI.1/GII.4 (15/15) - MPL (50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)5.2 titerStandard Deviation 3.41
GI.1/GII.4 (15/15) - MPL (50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 titerStandard Deviation 1.3
GI.1/GII.4 (15/15) - MPL (50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)11.3 titerStandard Deviation 4.25
GI.1/GII.4 (15/15) - MPL (50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)2.7 titerStandard Deviation 3.29
GI.1/GII.4 (15/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)5.5 titerStandard Deviation 3.18
GI.1/GII.4 (15/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)2.7 titerStandard Deviation 2.71
GI.1/GII.4 (15/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 titerStandard Deviation 1.08
GI.1/GII.4 (15/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)13.2 titerStandard Deviation 4.31
GI.1/GII.4 (50/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0.9 titerStandard Deviation 1.3
GI.1/GII.4 (50/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)6.0 titerStandard Deviation 2.97
GI.1/GII.4 (50/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)3.3 titerStandard Deviation 2.87
GI.1/GII.4 (50/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)14.9 titerStandard Deviation 3.54
GI.1/GII.4 (15/15) - MPL (15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)4.8 titerStandard Deviation 2.91
GI.1/GII.4 (15/15) - MPL (15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)2.6 titerStandard Deviation 2.97
GI.1/GII.4 (15/15) - MPL (15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)10.0 titerStandard Deviation 4.07
GI.1/GII.4 (15/15) - MPL (15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 titerStandard Deviation 1.21
GI.1/GII.4 (15/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)12.0 titerStandard Deviation 3.36
GI.1/GII.4 (15/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)2.3 titerStandard Deviation 2.65
GI.1/GII.4 (15/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 titerStandard Deviation 1.37
GI.1/GII.4 (15/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)4.2 titerStandard Deviation 2.94
GI.1/GII.4 (50/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)14.3 titerStandard Deviation 2.98
GI.1/GII.4 (50/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)5.9 titerStandard Deviation 2
GI.1/GII.4 (50/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0.9 titerStandard Deviation 1.26
GI.1/GII.4 (50/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)3.0 titerStandard Deviation 2.35
GI.1/GII.4 (15/15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)5.2 titerStandard Deviation 2.69
GI.1/GII.4 (15/15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)13.1 titerStandard Deviation 3.96
GI.1/GII.4 (15/15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)2.9 titerStandard Deviation 2.61
GI.1/GII.4 (15/15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0.9 titerStandard Deviation 1.59
GI.1/GII.4 (15/50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)8.2 titerStandard Deviation 3.14
GI.1/GII.4 (15/50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 titerStandard Deviation 1.22
GI.1/GII.4 (15/50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)16.9 titerStandard Deviation 4.6
GI.1/GII.4 (15/50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)4.4 titerStandard Deviation 3.3
GI.1/GII.4 (50/50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)21.1 titerStandard Deviation 3.72
GI.1/GII.4 (50/50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)4.0 titerStandard Deviation 3.1
GI.1/GII.4 (50/50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.1 titerStandard Deviation 1.37
GI.1/GII.4 (50/50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)8.6 titerStandard Deviation 2.63
GI.1/GII.4 (50/150)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)2.4 titerStandard Deviation 2.35
GI.1/GII.4 (50/150)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.1 titerStandard Deviation 1.28
GI.1/GII.4 (50/150)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)10.7 titerStandard Deviation 2.53
GI.1/GII.4 (50/150)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)4.9 titerStandard Deviation 2.24
GI.1/GII.4 (15/50) - Al(OH)3 (167)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)2.4 titerStandard Deviation 2.73
GI.1/GII.4 (15/50) - Al(OH)3 (167)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)9.7 titerStandard Deviation 4.29
GI.1/GII.4 (15/50) - Al(OH)3 (167)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)3.7 titerStandard Deviation 2.95
GI.1/GII.4 (15/50) - Al(OH)3 (167)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 titerStandard Deviation 1.31
GI.1/GII.4 (15/50) x2Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)15.0 titerStandard Deviation 3.8
GI.1/GII.4 (15/50) x2Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)8.5 titerStandard Deviation 2.52
GI.1/GII.4 (15/50) x2Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)4.5 titerStandard Deviation 3.29
GI.1/GII.4 (15/50) x2Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)17.2 titerStandard Deviation 2.36
GI.1/GII.4 (50/150) x2Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)17.3 titerStandard Deviation 3.02
GI.1/GII.4 (50/150) x2Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)20.8 titerStandard Deviation 2.2
GI.1/GII.4 (50/150) x2Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)9.8 titerStandard Deviation 2.18
GI.1/GII.4 (50/150) x2Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)5.1 titerStandard Deviation 2.81
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)3.8 titerStandard Deviation 2.6
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)19.3 titerStandard Deviation 3.33
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)7.9 titerStandard Deviation 2.21
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)17.9 titerStandard Deviation 2.68
Secondary

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

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 and for selected arms on day 208 and day 393. D=Day

Time frame: Days 28, 56, 208 and 393

Population: 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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
GI.1/GII.4 (15/15) - MPL (50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA ratio—
GI.1/GII.4 (15/15) - MPL (50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA ratio—
GI.1/GII.4 (15/15) - MPL (50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0.9 ratioStandard Deviation 1.52
GI.1/GII.4 (15/15) - MPL (50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)25.7 ratioStandard Deviation 4.46
GI.1/GII.4 (15/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA ratio—
GI.1/GII.4 (15/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0.9 ratioStandard Deviation 1.49
GI.1/GII.4 (15/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA ratio—
GI.1/GII.4 (15/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)28.0 ratioStandard Deviation 4.4
GI.1/GII.4 (50/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)49.2 ratioStandard Deviation 2.81
GI.1/GII.4 (50/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA ratio—
GI.1/GII.4 (50/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 ratioStandard Deviation 1.23
GI.1/GII.4 (50/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA ratio—
GI.1/GII.4 (15/15) - MPL (15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA ratio—
GI.1/GII.4 (15/15) - MPL (15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)34.2 ratioStandard Deviation 5.55
GI.1/GII.4 (15/15) - MPL (15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.3 ratioStandard Deviation 2.65
GI.1/GII.4 (15/15) - MPL (15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA ratio—
GI.1/GII.4 (15/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)10.0 ratioStandard Deviation 2.89
GI.1/GII.4 (15/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)7.4 ratioStandard Deviation 2.41
GI.1/GII.4 (15/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)45.4 ratioStandard Deviation 3.47
GI.1/GII.4 (15/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 ratioStandard Deviation 1.23
GI.1/GII.4 (50/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA ratio—
GI.1/GII.4 (50/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 ratioStandard Deviation 1.14
GI.1/GII.4 (50/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA ratio—
GI.1/GII.4 (50/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)41.5 ratioStandard Deviation 3.5
GI.1/GII.4 (15/15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)29.8 ratioStandard Deviation 4.63
GI.1/GII.4 (15/15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA ratio—
GI.1/GII.4 (15/15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA ratio—
GI.1/GII.4 (15/15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 ratioStandard Deviation 1.44
GI.1/GII.4 (15/50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)8.5 ratioStandard Deviation 3.77
GI.1/GII.4 (15/50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 ratioStandard Deviation 1.1
GI.1/GII.4 (15/50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)23.9 ratioStandard Deviation 4.13
GI.1/GII.4 (15/50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)5.2 ratioStandard Deviation 3.34
GI.1/GII.4 (50/50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA ratio—
GI.1/GII.4 (50/50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 ratioStandard Deviation 1.13
GI.1/GII.4 (50/50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)52.1 ratioStandard Deviation 3.61
GI.1/GII.4 (50/50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA ratio—
GI.1/GII.4 (50/150)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)25.8 ratioStandard Deviation 3.15
GI.1/GII.4 (50/150)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA ratio—
GI.1/GII.4 (50/150)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 ratioStandard Deviation 1.46
GI.1/GII.4 (50/150)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA ratio—
GI.1/GII.4 (15/50) - Al(OH)3 (167)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)20.8 ratioStandard Deviation 2.77
GI.1/GII.4 (15/50) - Al(OH)3 (167)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA ratio—
GI.1/GII.4 (15/50) - Al(OH)3 (167)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA ratio—
GI.1/GII.4 (15/50) - Al(OH)3 (167)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.2 ratioStandard Deviation 1.86
GI.1/GII.4 (15/50) x2Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)22.5 ratioStandard Deviation 2.95
GI.1/GII.4 (15/50) x2Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA ratio—
GI.1/GII.4 (15/50) x2Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA ratio—
GI.1/GII.4 (15/50) x2Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)11.1 ratioStandard Deviation 2.19
GI.1/GII.4 (50/150) x2Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)22.6 ratioStandard Deviation 2.29
GI.1/GII.4 (50/150) x2Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)52.7 ratioStandard Deviation 2.79
GI.1/GII.4 (50/150) x2Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA ratio—
GI.1/GII.4 (50/150) x2Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA ratio—
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)42.3 ratioStandard Deviation 2.39
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA ratio—
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)21.1 ratioStandard Deviation 2.81
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA ratio—
Secondary

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

Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by pan-Ig ELISA. D=Day

Time frame: Days 28, 56, 208 and 393

Population: 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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
GI.1/GII.4 (15/15) - MPL (50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)6.9 ratioStandard Deviation 3.63
GI.1/GII.4 (15/15) - MPL (50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)17.3 ratioStandard Deviation 3.69
GI.1/GII.4 (15/15) - MPL (50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 ratioStandard Deviation 1.13
GI.1/GII.4 (15/15) - MPL (50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)4.4 ratioStandard Deviation 3.27
GI.1/GII.4 (15/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)4.1 ratioStandard Deviation 4.46
GI.1/GII.4 (15/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)6.7 ratioStandard Deviation 3.71
GI.1/GII.4 (15/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0.9 ratioStandard Deviation 1.18
GI.1/GII.4 (15/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)18.8 ratioStandard Deviation 3.46
GI.1/GII.4 (50/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)7.0 ratioStandard Deviation 3.56
GI.1/GII.4 (50/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0.8 ratioStandard Deviation 1.5
GI.1/GII.4 (50/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)9.3 ratioStandard Deviation 3.77
GI.1/GII.4 (50/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)25.8 ratioStandard Deviation 3.09
GI.1/GII.4 (15/15) - MPL (15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)9.0 ratioStandard Deviation 4.32
GI.1/GII.4 (15/15) - MPL (15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.2 ratioStandard Deviation 2.85
GI.1/GII.4 (15/15) - MPL (15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)22.4 ratioStandard Deviation 4.38
GI.1/GII.4 (15/15) - MPL (15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)8.0 ratioStandard Deviation 4.65
GI.1/GII.4 (15/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0.9 ratioStandard Deviation 1.26
GI.1/GII.4 (15/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)7.1 ratioStandard Deviation 2.63
GI.1/GII.4 (15/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)22.4 ratioStandard Deviation 3.02
GI.1/GII.4 (15/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)5.1 ratioStandard Deviation 2.41
GI.1/GII.4 (50/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)35.1 ratioStandard Deviation 3.88
GI.1/GII.4 (50/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)7.4 ratioStandard Deviation 3.36
GI.1/GII.4 (50/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 ratioStandard Deviation 1.16
GI.1/GII.4 (50/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)10.4 ratioStandard Deviation 3.79
GI.1/GII.4 (15/15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)5.3 ratioStandard Deviation 3.4
GI.1/GII.4 (15/15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)6.4 ratioStandard Deviation 3.62
GI.1/GII.4 (15/15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 ratioStandard Deviation 1.36
GI.1/GII.4 (15/15)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)18.1 ratioStandard Deviation 4.35
GI.1/GII.4 (15/50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)19.0 ratioStandard Deviation 3.67
GI.1/GII.4 (15/50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 ratioStandard Deviation 1.18
GI.1/GII.4 (15/50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)5.7 ratioStandard Deviation 3.41
GI.1/GII.4 (15/50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)8.5 ratioStandard Deviation 3.9
GI.1/GII.4 (50/50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)7.8 ratioStandard Deviation 2.87
GI.1/GII.4 (50/50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)36.5 ratioStandard Deviation 4.85
GI.1/GII.4 (50/50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0.9 ratioStandard Deviation 1.28
GI.1/GII.4 (50/50)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)10.7 ratioStandard Deviation 3
GI.1/GII.4 (50/150)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)4.3 ratioStandard Deviation 2.58
GI.1/GII.4 (50/150)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0.9 ratioStandard Deviation 1.28
GI.1/GII.4 (50/150)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)6.5 ratioStandard Deviation 2.96
GI.1/GII.4 (50/150)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)18.7 ratioStandard Deviation 3.31
GI.1/GII.4 (15/50) - Al(OH)3 (167)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)5.2 ratioStandard Deviation 3.27
GI.1/GII.4 (15/50) - Al(OH)3 (167)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)13.5 ratioStandard Deviation 3.07
GI.1/GII.4 (15/50) - Al(OH)3 (167)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)4.0 ratioStandard Deviation 3.08
GI.1/GII.4 (15/50) - Al(OH)3 (167)Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 ratioStandard Deviation 1.58
GI.1/GII.4 (15/50) x2Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)9.3 ratioStandard Deviation 3.57
GI.1/GII.4 (15/50) x2Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)17.0 ratioStandard Deviation 3.63
GI.1/GII.4 (15/50) x2Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)19.5 ratioStandard Deviation 3.73
GI.1/GII.4 (15/50) x2Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)6.4 ratioStandard Deviation 4.07
GI.1/GII.4 (50/150) x2Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)8.3 ratioStandard Deviation 2.79
GI.1/GII.4 (50/150) x2Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)19.7 ratioStandard Deviation 2.78
GI.1/GII.4 (50/150) x2Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)23.2 ratioStandard Deviation 3
GI.1/GII.4 (50/150) x2Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)6.3 ratioStandard Deviation 2.95
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)7.8 ratioStandard Deviation 3.52
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)16.8 ratioStandard Deviation 2.74
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)6.1 ratioStandard Deviation 2.85
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)22.0 ratioStandard Deviation 2.57
Secondary

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

Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by the HBGA binding assay. D=Day

Time frame: Days 28, 56, 208 and 393

Population: 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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
GI.1/GII.4 (15/15) - MPL (50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)5.1 titerStandard Deviation 4.42
GI.1/GII.4 (15/15) - MPL (50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)2.8 titerStandard Deviation 3.1
GI.1/GII.4 (15/15) - MPL (50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)1.7 titerStandard Deviation 3.14
GI.1/GII.4 (15/15) - MPL (50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.1 titerStandard Deviation 1.68
GI.1/GII.4 (15/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)8.9 titerStandard Deviation 3.31
GI.1/GII.4 (15/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)2.3 titerStandard Deviation 2.42
GI.1/GII.4 (15/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)3.1 titerStandard Deviation 2.51
GI.1/GII.4 (15/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0.9 titerStandard Deviation 1.59
GI.1/GII.4 (50/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)2.0 titerStandard Deviation 2.42
GI.1/GII.4 (50/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 titerStandard Deviation 1.47
GI.1/GII.4 (50/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)1.0 titerStandard Deviation 2.43
GI.1/GII.4 (50/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)3.6 titerStandard Deviation 2.71
GI.1/GII.4 (15/15) - MPL (15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)3.7 titerStandard Deviation 3.43
GI.1/GII.4 (15/15) - MPL (15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)2.4 titerStandard Deviation 2.58
GI.1/GII.4 (15/15) - MPL (15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)1.5 titerStandard Deviation 2.56
GI.1/GII.4 (15/15) - MPL (15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 titerStandard Deviation 1.73
GI.1/GII.4 (15/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)1.7 titerStandard Deviation 2.32
GI.1/GII.4 (15/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)3.8 titerStandard Deviation 2.56
GI.1/GII.4 (15/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)11.1 titerStandard Deviation 3.32
GI.1/GII.4 (15/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.1 titerStandard Deviation 1.62
GI.1/GII.4 (50/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)6.5 titerStandard Deviation 3.33
GI.1/GII.4 (50/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)2.5 titerStandard Deviation 1.99
GI.1/GII.4 (50/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 titerStandard Deviation 1.38
GI.1/GII.4 (50/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)1.4 titerStandard Deviation 1.82
GI.1/GII.4 (15/15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)1.8 titerStandard Deviation 2.27
GI.1/GII.4 (15/15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)2.3 titerStandard Deviation 2.95
GI.1/GII.4 (15/15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)1.3 titerStandard Deviation 2.25
GI.1/GII.4 (15/15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0.9 titerStandard Deviation 1.29
GI.1/GII.4 (15/50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)3.9 titerStandard Deviation 3.03
GI.1/GII.4 (15/50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.1 titerStandard Deviation 1.89
GI.1/GII.4 (15/50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)9.4 titerStandard Deviation 3.95
GI.1/GII.4 (15/50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)2.0 titerStandard Deviation 2.59
GI.1/GII.4 (50/50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)2.0 titerStandard Deviation 2.3
GI.1/GII.4 (50/50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)1.3 titerStandard Deviation 2.28
GI.1/GII.4 (50/50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 titerStandard Deviation 1.59
GI.1/GII.4 (50/50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)3.5 titerStandard Deviation 3.61
GI.1/GII.4 (50/150)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.2 titerStandard Deviation 2.45
GI.1/GII.4 (50/150)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)1.8 titerStandard Deviation 2.11
GI.1/GII.4 (50/150)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)8.4 titerStandard Deviation 3.59
GI.1/GII.4 (50/150)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)3.3 titerStandard Deviation 2.66
GI.1/GII.4 (15/50) - Al(OH)3 (167)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)2.5 titerStandard Deviation 1.73
GI.1/GII.4 (15/50) - Al(OH)3 (167)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)1.6 titerStandard Deviation 1.9
GI.1/GII.4 (15/50) - Al(OH)3 (167)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)6.0 titerStandard Deviation 2.24
GI.1/GII.4 (15/50) - Al(OH)3 (167)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 titerStandard Deviation 1.46
GI.1/GII.4 (15/50) x2Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)7.6 titerStandard Deviation 3.19
GI.1/GII.4 (15/50) x2Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)2.2 titerStandard Deviation 2.7
GI.1/GII.4 (15/50) x2Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)4.9 titerStandard Deviation 2.72
GI.1/GII.4 (15/50) x2Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)9.8 titerStandard Deviation 3.48
GI.1/GII.4 (50/150) x2Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)6.5 titerStandard Deviation 2.94
GI.1/GII.4 (50/150) x2Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)3.8 titerStandard Deviation 2.81
GI.1/GII.4 (50/150) x2Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)7.5 titerStandard Deviation 3.13
GI.1/GII.4 (50/150) x2Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)1.9 titerStandard Deviation 2.62
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)7.0 titerStandard Deviation 2.96
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)2.5 titerStandard Deviation 2.35
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)4.8 titerStandard Deviation 2.46
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)1.4 titerStandard Deviation 2.23
Secondary

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

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 and for selected arms on day 208 and day 393. D=Day

Time frame: Days 28, 56, 208 and 393

Population: 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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
GI.1/GII.4 (15/15) - MPL (50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA ratio—
GI.1/GII.4 (15/15) - MPL (50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA ratio—
GI.1/GII.4 (15/15) - MPL (50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0.9 ratioStandard Deviation 1.33
GI.1/GII.4 (15/15) - MPL (50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)5.9 ratioStandard Deviation 4.37
GI.1/GII.4 (15/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)7.7 ratioStandard Deviation 3.92
GI.1/GII.4 (15/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA ratio—
GI.1/GII.4 (15/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA ratio—
GI.1/GII.4 (15/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 ratioStandard Deviation 1.42
GI.1/GII.4 (50/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 ratioStandard Deviation 1.13
GI.1/GII.4 (50/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA ratio—
GI.1/GII.4 (50/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)3.6 ratioStandard Deviation 2.45
GI.1/GII.4 (50/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA ratio—
GI.1/GII.4 (15/15) - MPL (15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA ratio—
GI.1/GII.4 (15/15) - MPL (15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA ratio—
GI.1/GII.4 (15/15) - MPL (15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)4.2 ratioStandard Deviation 2.54
GI.1/GII.4 (15/15) - MPL (15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.1 ratioStandard Deviation 1.27
GI.1/GII.4 (15/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)1.9 ratioStandard Deviation 2.47
GI.1/GII.4 (15/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 ratioStandard Deviation 1.14
GI.1/GII.4 (15/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)11.0 ratioStandard Deviation 3.48
GI.1/GII.4 (15/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)3.5 ratioStandard Deviation 2.67
GI.1/GII.4 (50/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)6.2 ratioStandard Deviation 3.36
GI.1/GII.4 (50/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA ratio—
GI.1/GII.4 (50/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA ratio—
GI.1/GII.4 (50/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 ratioStandard Deviation 1.09
GI.1/GII.4 (15/15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.1 ratioStandard Deviation 1.44
GI.1/GII.4 (15/15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)3.4 ratioStandard Deviation 2.7
GI.1/GII.4 (15/15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA ratio—
GI.1/GII.4 (15/15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA ratio—
GI.1/GII.4 (15/50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)8.2 ratioStandard Deviation 3.36
GI.1/GII.4 (15/50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)1.9 ratioStandard Deviation 2.26
GI.1/GII.4 (15/50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)3.2 ratioStandard Deviation 2.44
GI.1/GII.4 (15/50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 ratioStandard Deviation 1.6
GI.1/GII.4 (50/50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)4.0 ratioStandard Deviation 3.14
GI.1/GII.4 (50/50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 ratioStandard Deviation 1.1
GI.1/GII.4 (50/50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA ratio—
GI.1/GII.4 (50/50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA ratio—
GI.1/GII.4 (50/150)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 ratioStandard Deviation 1.36
GI.1/GII.4 (50/150)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA ratio—
GI.1/GII.4 (50/150)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA ratio—
GI.1/GII.4 (50/150)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)7.1 ratioStandard Deviation 2.81
GI.1/GII.4 (15/50) - Al(OH)3 (167)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA ratio—
GI.1/GII.4 (15/50) - Al(OH)3 (167)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA ratio—
GI.1/GII.4 (15/50) - Al(OH)3 (167)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 ratioStandard Deviation 1.22
GI.1/GII.4 (15/50) - Al(OH)3 (167)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)4.9 ratioStandard Deviation 2.35
GI.1/GII.4 (15/50) x2Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)5.5 ratioStandard Deviation 4.74
GI.1/GII.4 (15/50) x2Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA ratio—
GI.1/GII.4 (15/50) x2Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA ratio—
GI.1/GII.4 (15/50) x2Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)9.0 ratioStandard Deviation 2.85
GI.1/GII.4 (50/150) x2Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA ratio—
GI.1/GII.4 (50/150) x2Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)7.8 ratioStandard Deviation 2.89
GI.1/GII.4 (50/150) x2Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)4.5 ratioStandard Deviation 2.53
GI.1/GII.4 (50/150) x2Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA ratio—
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA ratio—
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)3.9 ratioStandard Deviation 2.41
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)6.3 ratioStandard Deviation 3.11
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA ratio—
Secondary

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

Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by pan-Ig ELISA. D=Day

Time frame: Days 28, 56, 208 and 393

Population: 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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
GI.1/GII.4 (15/15) - MPL (50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0.9 ratioStandard Deviation 1.56
GI.1/GII.4 (15/15) - MPL (50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)2.1 ratioStandard Deviation 2.45
GI.1/GII.4 (15/15) - MPL (50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)4.2 ratioStandard Deviation 3.11
GI.1/GII.4 (15/15) - MPL (50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)1.9 ratioStandard Deviation 2.77
GI.1/GII.4 (15/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)3.0 ratioStandard Deviation 2.74
GI.1/GII.4 (15/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 ratioStandard Deviation 1.14
GI.1/GII.4 (15/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)2.6 ratioStandard Deviation 3.2
GI.1/GII.4 (15/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)7.2 ratioStandard Deviation 2.98
GI.1/GII.4 (50/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)1.9 ratioStandard Deviation 1.96
GI.1/GII.4 (50/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 ratioStandard Deviation 1.23
GI.1/GII.4 (50/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)4.0 ratioStandard Deviation 2.66
GI.1/GII.4 (50/50) - MPL (50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)1.7 ratioStandard Deviation 2.41
GI.1/GII.4 (15/15) - MPL (15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 ratioStandard Deviation 1.21
GI.1/GII.4 (15/15) - MPL (15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)2.0 ratioStandard Deviation 2.33
GI.1/GII.4 (15/15) - MPL (15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)2.6 ratioStandard Deviation 2.5
GI.1/GII.4 (15/15) - MPL (15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)4.1 ratioStandard Deviation 2.97
GI.1/GII.4 (15/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)2.1 ratioStandard Deviation 2.34
GI.1/GII.4 (15/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0.9 ratioStandard Deviation 1.18
GI.1/GII.4 (15/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)8.2 ratioStandard Deviation 2.72
GI.1/GII.4 (15/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)3.2 ratioStandard Deviation 2.36
GI.1/GII.4 (50/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)1.9 ratioStandard Deviation 1.99
GI.1/GII.4 (50/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)6.9 ratioStandard Deviation 3.31
GI.1/GII.4 (50/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 ratioStandard Deviation 1.13
GI.1/GII.4 (50/50) - MPL (15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)2.7 ratioStandard Deviation 2.21
GI.1/GII.4 (15/15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)2.6 ratioStandard Deviation 2.6
GI.1/GII.4 (15/15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0.9 ratioStandard Deviation 1.37
GI.1/GII.4 (15/15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)1.7 ratioStandard Deviation 2.17
GI.1/GII.4 (15/15)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)1.6 ratioStandard Deviation 2.46
GI.1/GII.4 (15/50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.1 ratioStandard Deviation 1.57
GI.1/GII.4 (15/50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)4.1 ratioStandard Deviation 2.45
GI.1/GII.4 (15/50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)8.0 ratioStandard Deviation 3.36
GI.1/GII.4 (15/50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)2.4 ratioStandard Deviation 2.4
GI.1/GII.4 (50/50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)4.0 ratioStandard Deviation 3
GI.1/GII.4 (50/50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)1.5 ratioStandard Deviation 2.27
GI.1/GII.4 (50/50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)2.0 ratioStandard Deviation 2.06
GI.1/GII.4 (50/50)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 ratioStandard Deviation 1.17
GI.1/GII.4 (50/150)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 ratioStandard Deviation 1.58
GI.1/GII.4 (50/150)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)1.7 ratioStandard Deviation 2.41
GI.1/GII.4 (50/150)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)7.2 ratioStandard Deviation 3.38
GI.1/GII.4 (50/150)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)3.1 ratioStandard Deviation 2.61
GI.1/GII.4 (15/50) - Al(OH)3 (167)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 ratioStandard Deviation 1.25
GI.1/GII.4 (15/50) - Al(OH)3 (167)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)4.7 ratioStandard Deviation 1.97
GI.1/GII.4 (15/50) - Al(OH)3 (167)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)2.2 ratioStandard Deviation 1.92
GI.1/GII.4 (15/50) - Al(OH)3 (167)Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)1.4 ratioStandard Deviation 2.27
GI.1/GII.4 (15/50) x2Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)6.8 ratioStandard Deviation 2.99
GI.1/GII.4 (15/50) x2Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)2.5 ratioStandard Deviation 2.6
GI.1/GII.4 (15/50) x2Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)8.7 ratioStandard Deviation 3.25
GI.1/GII.4 (15/50) x2Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)3.9 ratioStandard Deviation 2.7
GI.1/GII.4 (50/150) x2Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)3.5 ratioStandard Deviation 2.24
GI.1/GII.4 (50/150) x2Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)9.7 ratioStandard Deviation 3.02
GI.1/GII.4 (50/150) x2Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)7.5 ratioStandard Deviation 2.74
GI.1/GII.4 (50/150) x2Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)2.4 ratioStandard Deviation 2.22
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)1.7 ratioStandard Deviation 2.64
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)2.5 ratioStandard Deviation 2.57
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)6.7 ratioStandard Deviation 3.11
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)5.0 ratioStandard Deviation 2.7
Secondary

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

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 and for selected arms on day 208 and day 393. D=Day

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

Population: 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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
GI.1/GII.4 (15/15) - MPL (50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/15) - MPL (50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)52.9 titerStandard Deviation 4.86
GI.1/GII.4 (15/15) - MPL (50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/15) - MPL (50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,301358.4 titerStandard Deviation 4.02
GI.1/GII.4 (15/15) - MPL (50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)48.9 titerStandard Deviation 4.99
GI.1/GII.4 (15/50) - MPL (50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30996.2 titerStandard Deviation 5.02
GI.1/GII.4 (15/50) - MPL (50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) - MPL (50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)37.4 titerStandard Deviation 3.59
GI.1/GII.4 (15/50) - MPL (50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)34.6 titerStandard Deviation 3.38
GI.1/GII.4 (15/50) - MPL (50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/50) - MPL (50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)42.1 titerStandard Deviation 3.63
GI.1/GII.4 (50/50) - MPL (50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/50) - MPL (50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)41.2 titerStandard Deviation 3.85
GI.1/GII.4 (50/50) - MPL (50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/50) - MPL (50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,302223.3 titerStandard Deviation 2.91
GI.1/GII.4 (15/15) - MPL (15)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/15) - MPL (15)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)32.1 titerStandard Deviation 5.26
GI.1/GII.4 (15/15) - MPL (15)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/15) - MPL (15)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)41.0 titerStandard Deviation 4.38
GI.1/GII.4 (15/15) - MPL (15)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,301068.7 titerStandard Deviation 5.39
GI.1/GII.4 (15/50) - MPL (15)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)29.4 titerStandard Deviation 3.31
GI.1/GII.4 (15/50) - MPL (15)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)30.1 titerStandard Deviation 3.26
GI.1/GII.4 (15/50) - MPL (15)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)302.5 titerStandard Deviation 4.1
GI.1/GII.4 (15/50) - MPL (15)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,301368.6 titerStandard Deviation 3.99
GI.1/GII.4 (15/50) - MPL (15)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)224.0 titerStandard Deviation 2.73
GI.1/GII.4 (50/50) - MPL (15)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)46.2 titerStandard Deviation 6.22
GI.1/GII.4 (50/50) - MPL (15)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/50) - MPL (15)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/50) - MPL (15)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,301849.8 titerStandard Deviation 3.35
GI.1/GII.4 (50/50) - MPL (15)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)44.5 titerStandard Deviation 6.06
GI.1/GII.4 (15/15)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/15)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,301594.9 titerStandard Deviation 4.87
GI.1/GII.4 (15/15)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/15)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)53.6 titerStandard Deviation 5.76
GI.1/GII.4 (15/15)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)54.4 titerStandard Deviation 5.67
GI.1/GII.4 (15/50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)512.4 titerStandard Deviation 5.85
GI.1/GII.4 (15/50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)60.1 titerStandard Deviation 6.45
GI.1/GII.4 (15/50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)59.8 titerStandard Deviation 6.23
GI.1/GII.4 (15/50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,301435.5 titerStandard Deviation 7.02
GI.1/GII.4 (15/50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)340.1 titerStandard Deviation 3.91
GI.1/GII.4 (50/50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)36.8 titerStandard Deviation 5.3
GI.1/GII.4 (50/50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)37.8 titerStandard Deviation 5.2
GI.1/GII.4 (50/50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,302074.3 titerStandard Deviation 4.4
GI.1/GII.4 (50/150)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)56.3 titerStandard Deviation 3.95
GI.1/GII.4 (50/150)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,301510.6 titerStandard Deviation 4.45
GI.1/GII.4 (50/150)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/150)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/150)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)58.5 titerStandard Deviation 4.08
GI.1/GII.4 (15/50) - Al(OH)3 (167)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)57.0 titerStandard Deviation 5.31
GI.1/GII.4 (15/50) - Al(OH)3 (167)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) - Al(OH)3 (167)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)47.0 titerStandard Deviation 4.91
GI.1/GII.4 (15/50) - Al(OH)3 (167)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) - Al(OH)3 (167)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,301131.2 titerStandard Deviation 4.28
GI.1/GII.4 (15/50) x2Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)1649.9 titerStandard Deviation 4.88
GI.1/GII.4 (15/50) x2Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)73.3 titerStandard Deviation 5.24
GI.1/GII.4 (15/50) x2Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) x2Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) x2Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30810.7 titerStandard Deviation 5.58
GI.1/GII.4 (50/150) x2Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)2148.2 titerStandard Deviation 2.98
GI.1/GII.4 (50/150) x2Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/150) x2Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30922.6 titerStandard Deviation 3.73
GI.1/GII.4 (50/150) x2Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/150) x2Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)40.8 titerStandard Deviation 4.25
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)1703.2 titerStandard Deviation 2.62
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)41.5 titerStandard Deviation 3.74
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30848.2 titerStandard Deviation 3.63
Secondary

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

Geometric mean titer (GMT) of anti-norovirus GI.1 VLP antibody titers as measured by pan-Ig ELISA. D=Day

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

Population: 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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
GI.1/GII.4 (15/15) - MPL (50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)833.4 titerStandard Deviation 4.64
GI.1/GII.4 (15/15) - MPL (50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)5725.2 titerStandard Deviation 2.37
GI.1/GII.4 (15/15) - MPL (50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)3886.0 titerStandard Deviation 2.98
GI.1/GII.4 (15/15) - MPL (50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)14417.7 titerStandard Deviation 2.74
GI.1/GII.4 (15/15) - MPL (50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)798.9 titerStandard Deviation 4.66
GI.1/GII.4 (15/50) - MPL (50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)737.9 titerStandard Deviation 4.42
GI.1/GII.4 (15/50) - MPL (50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)5069.7 titerStandard Deviation 2.48
GI.1/GII.4 (15/50) - MPL (50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)790.3 titerStandard Deviation 4.5
GI.1/GII.4 (15/50) - MPL (50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)3179.7 titerStandard Deviation 2.78
GI.1/GII.4 (15/50) - MPL (50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)14171.3 titerStandard Deviation 2.76
GI.1/GII.4 (50/50) - MPL (50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)17504.8 titerStandard Deviation 2.64
GI.1/GII.4 (50/50) - MPL (50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)6084.3 titerStandard Deviation 2.43
GI.1/GII.4 (50/50) - MPL (50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)4470.4 titerStandard Deviation 2.55
GI.1/GII.4 (50/50) - MPL (50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)548.5 titerStandard Deviation 4.47
GI.1/GII.4 (50/50) - MPL (50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)636.7 titerStandard Deviation 4.6
GI.1/GII.4 (15/15) - MPL (15)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)5009.0 titerStandard Deviation 2.8
GI.1/GII.4 (15/15) - MPL (15)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)14220.4 titerStandard Deviation 3.23
GI.1/GII.4 (15/15) - MPL (15)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)647.6 titerStandard Deviation 5.17
GI.1/GII.4 (15/15) - MPL (15)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)806.6 titerStandard Deviation 5.36
GI.1/GII.4 (15/15) - MPL (15)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)5613.9 titerStandard Deviation 2.68
GI.1/GII.4 (15/50) - MPL (15)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)573.6 titerStandard Deviation 3.08
GI.1/GII.4 (15/50) - MPL (15)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)625.3 titerStandard Deviation 2.96
GI.1/GII.4 (15/50) - MPL (15)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)13982.2 titerStandard Deviation 2.33
GI.1/GII.4 (15/50) - MPL (15)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)3209.6 titerStandard Deviation 2.54
GI.1/GII.4 (15/50) - MPL (15)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)4467.6 titerStandard Deviation 2.05
GI.1/GII.4 (50/50) - MPL (15)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)514.6 titerStandard Deviation 5.19
GI.1/GII.4 (50/50) - MPL (15)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)3874.5 titerStandard Deviation 2.55
GI.1/GII.4 (50/50) - MPL (15)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)18266.0 titerStandard Deviation 1.99
GI.1/GII.4 (50/50) - MPL (15)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)520.3 titerStandard Deviation 4.99
GI.1/GII.4 (50/50) - MPL (15)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)5106.4 titerStandard Deviation 2.06
GI.1/GII.4 (15/15)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)5660.5 titerStandard Deviation 2.22
GI.1/GII.4 (15/15)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)16082.5 titerStandard Deviation 2.07
GI.1/GII.4 (15/15)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)910.4 titerStandard Deviation 4.37
GI.1/GII.4 (15/15)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)4940.3 titerStandard Deviation 2.48
GI.1/GII.4 (15/15)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)890.5 titerStandard Deviation 4.75
GI.1/GII.4 (15/50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)15974.2 titerStandard Deviation 3.95
GI.1/GII.4 (15/50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)842.9 titerStandard Deviation 4.92
GI.1/GII.4 (15/50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)821.5 titerStandard Deviation 4.84
GI.1/GII.4 (15/50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)7174.8 titerStandard Deviation 2.47
GI.1/GII.4 (15/50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)4773.3 titerStandard Deviation 2.62
GI.1/GII.4 (50/50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)25808.9 titerStandard Deviation 2.55
GI.1/GII.4 (50/50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)7542.0 titerStandard Deviation 2.28
GI.1/GII.4 (50/50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)638.5 titerStandard Deviation 3.9
GI.1/GII.4 (50/50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)677.2 titerStandard Deviation 3.75
GI.1/GII.4 (50/50)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)5550.1 titerStandard Deviation 2.7
GI.1/GII.4 (50/150)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)827.3 titerStandard Deviation 4.82
GI.1/GII.4 (50/150)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)3542.9 titerStandard Deviation 2.54
GI.1/GII.4 (50/150)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)780.6 titerStandard Deviation 5.11
GI.1/GII.4 (50/150)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)15466.3 titerStandard Deviation 2.59
GI.1/GII.4 (50/150)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)5361.1 titerStandard Deviation 2.37
GI.1/GII.4 (15/50) - Al(OH)3 (167)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)856.7 titerStandard Deviation 5.34
GI.1/GII.4 (15/50) - Al(OH)3 (167)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)3960.0 titerStandard Deviation 2.55
GI.1/GII.4 (15/50) - Al(OH)3 (167)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)889.7 titerStandard Deviation 5.34
GI.1/GII.4 (15/50) - Al(OH)3 (167)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)14045.2 titerStandard Deviation 2.94
GI.1/GII.4 (15/50) - Al(OH)3 (167)Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)5162.8 titerStandard Deviation 2.18
GI.1/GII.4 (15/50) x2Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)741.5 titerStandard Deviation 5.28
GI.1/GII.4 (15/50) x2Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)6863.9 titerStandard Deviation 2.27
GI.1/GII.4 (15/50) x2Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)12613.2 titerStandard Deviation 2.46
GI.1/GII.4 (15/50) x2Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)4715.8 titerStandard Deviation 2.51
GI.1/GII.4 (15/50) x2Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)14488.6 titerStandard Deviation 3
GI.1/GII.4 (50/150) x2Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)17696.3 titerStandard Deviation 1.92
GI.1/GII.4 (50/150) x2Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)20839.2 titerStandard Deviation 1.96
GI.1/GII.4 (50/150) x2Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)5686.7 titerStandard Deviation 2.17
GI.1/GII.4 (50/150) x2Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)7459.1 titerStandard Deviation 1.72
GI.1/GII.4 (50/150) x2Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)897.5 titerStandard Deviation 3.74
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)4404.7 titerStandard Deviation 2.19
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)742.7 titerStandard Deviation 3.69
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)5912.6 titerStandard Deviation 1.94
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)15967.7 titerStandard Deviation 2.39
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)12235.7 titerStandard Deviation 2.11
Secondary

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

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 and for selected arms on day 208 and day 393. D=Day

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

Population: 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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
GI.1/GII.4 (15/15) - MPL (50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/15) - MPL (50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)83.4 titerStandard Deviation 6.63
GI.1/GII.4 (15/15) - MPL (50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)495.7 titerStandard Deviation 3.3
GI.1/GII.4 (15/15) - MPL (50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/15) - MPL (50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)77.8 titerStandard Deviation 6.49
GI.1/GII.4 (15/50) - MPL (50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)110.0 titerStandard Deviation 4.31
GI.1/GII.4 (15/50) - MPL (50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) - MPL (50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) - MPL (50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)113.6 titerStandard Deviation 4.43
GI.1/GII.4 (15/50) - MPL (50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)840.8 titerStandard Deviation 2.87
GI.1/GII.4 (50/50) - MPL (50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)583.7 titerStandard Deviation 2.34
GI.1/GII.4 (50/50) - MPL (50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/50) - MPL (50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)145.5 titerStandard Deviation 4.72
GI.1/GII.4 (50/50) - MPL (50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/50) - MPL (50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)151.2 titerStandard Deviation 4.7
GI.1/GII.4 (15/15) - MPL (15)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)119.5 titerStandard Deviation 4.47
GI.1/GII.4 (15/15) - MPL (15)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/15) - MPL (15)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/15) - MPL (15)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)467.9 titerStandard Deviation 2.79
GI.1/GII.4 (15/15) - MPL (15)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)125.3 titerStandard Deviation 4.34
GI.1/GII.4 (15/50) - MPL (15)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)73.8 titerStandard Deviation 4.42
GI.1/GII.4 (15/50) - MPL (15)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)72.8 titerStandard Deviation 4.64
GI.1/GII.4 (15/50) - MPL (15)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)139.7 titerStandard Deviation 4.07
GI.1/GII.4 (15/50) - MPL (15)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)803.3 titerStandard Deviation 3.24
GI.1/GII.4 (15/50) - MPL (15)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)251.8 titerStandard Deviation 3.94
GI.1/GII.4 (50/50) - MPL (15)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)714.2 titerStandard Deviation 2.44
GI.1/GII.4 (50/50) - MPL (15)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)114.6 titerStandard Deviation 4.56
GI.1/GII.4 (50/50) - MPL (15)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)116.3 titerStandard Deviation 4.49
GI.1/GII.4 (50/50) - MPL (15)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/50) - MPL (15)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/15)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)336.7 titerStandard Deviation 3.74
GI.1/GII.4 (15/15)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)100.2 titerStandard Deviation 4.47
GI.1/GII.4 (15/15)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)106.3 titerStandard Deviation 4.05
GI.1/GII.4 (15/15)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/15)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)427.9 titerStandard Deviation 3.95
GI.1/GII.4 (15/50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)1088.9 titerStandard Deviation 3.72
GI.1/GII.4 (15/50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)139.2 titerStandard Deviation 5.48
GI.1/GII.4 (15/50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)273.4 titerStandard Deviation 3.59
GI.1/GII.4 (15/50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)133.0 titerStandard Deviation 4.77
GI.1/GII.4 (50/50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)106.3 titerStandard Deviation 4.71
GI.1/GII.4 (50/50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)513.9 titerStandard Deviation 3.82
GI.1/GII.4 (50/50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)114.3 titerStandard Deviation 4.65
GI.1/GII.4 (50/150)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/150)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)164.8 titerStandard Deviation 3.16
GI.1/GII.4 (50/150)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)158.5 titerStandard Deviation 3.41
GI.1/GII.4 (50/150)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)1117.7 titerStandard Deviation 3.03
GI.1/GII.4 (50/150)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) - Al(OH)3 (167)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)1027.3 titerStandard Deviation 2.36
GI.1/GII.4 (15/50) - Al(OH)3 (167)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) - Al(OH)3 (167)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)201.7 titerStandard Deviation 3.3
GI.1/GII.4 (15/50) - Al(OH)3 (167)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) - Al(OH)3 (167)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)218.8 titerStandard Deviation 3.07
GI.1/GII.4 (15/50) x2Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) x2Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)953.5 titerStandard Deviation 2.83
GI.1/GII.4 (15/50) x2Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) x2Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)105.9 titerStandard Deviation 4.08
GI.1/GII.4 (15/50) x2Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)578.8 titerStandard Deviation 3.11
GI.1/GII.4 (50/150) x2Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)552.2 titerStandard Deviation 2.6
GI.1/GII.4 (50/150) x2Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/150) x2Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)948.2 titerStandard Deviation 2.52
GI.1/GII.4 (50/150) x2Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/150) x2Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)121.9 titerStandard Deviation 4.16
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)1118.0 titerStandard Deviation 2.91
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)174.5 titerStandard Deviation 4.13
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)691.2 titerStandard Deviation 3.12
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
Secondary

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

Geometric mean titer (GMT) of anti-norovirus GII.4 VLP antibody titers as measured by pan-Ig ELISA. D=Day

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

Population: 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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
GI.1/GII.4 (15/15) - MPL (50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)1016.8 titerStandard Deviation 5.56
GI.1/GII.4 (15/15) - MPL (50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)4595.7 titerStandard Deviation 3
GI.1/GII.4 (15/15) - MPL (50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)2236.5 titerStandard Deviation 3.84
GI.1/GII.4 (15/15) - MPL (50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)2341.2 titerStandard Deviation 3.93
GI.1/GII.4 (15/15) - MPL (50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)1106.6 titerStandard Deviation 4.68
GI.1/GII.4 (15/50) - MPL (50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)3653.0 titerStandard Deviation 2.24
GI.1/GII.4 (15/50) - MPL (50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)1232.6 titerStandard Deviation 3.46
GI.1/GII.4 (15/50) - MPL (50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)1249.2 titerStandard Deviation 3.45
GI.1/GII.4 (15/50) - MPL (50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)8636.7 titerStandard Deviation 2.05
GI.1/GII.4 (15/50) - MPL (50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)3103.0 titerStandard Deviation 3.03
GI.1/GII.4 (50/50) - MPL (50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)2450.2 titerStandard Deviation 2.87
GI.1/GII.4 (50/50) - MPL (50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)2993.2 titerStandard Deviation 3.61
GI.1/GII.4 (50/50) - MPL (50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)1477.7 titerStandard Deviation 4.13
GI.1/GII.4 (50/50) - MPL (50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)1540.6 titerStandard Deviation 3.83
GI.1/GII.4 (50/50) - MPL (50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)5750.4 titerStandard Deviation 2.15
GI.1/GII.4 (15/15) - MPL (15)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)1110.4 titerStandard Deviation 3.84
GI.1/GII.4 (15/15) - MPL (15)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)2175.3 titerStandard Deviation 2.91
GI.1/GII.4 (15/15) - MPL (15)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)4391.5 titerStandard Deviation 2.66
GI.1/GII.4 (15/15) - MPL (15)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)2887.7 titerStandard Deviation 2.78
GI.1/GII.4 (15/15) - MPL (15)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)1109.2 titerStandard Deviation 4.1
GI.1/GII.4 (15/50) - MPL (15)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)1946.4 titerStandard Deviation 2.51
GI.1/GII.4 (15/50) - MPL (15)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)839.4 titerStandard Deviation 3.04
GI.1/GII.4 (15/50) - MPL (15)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)921.7 titerStandard Deviation 3.15
GI.1/GII.4 (15/50) - MPL (15)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)7545.2 titerStandard Deviation 2.61
GI.1/GII.4 (15/50) - MPL (15)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)2984.6 titerStandard Deviation 2.62
GI.1/GII.4 (50/50) - MPL (15)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)2173.7 titerStandard Deviation 2.73
GI.1/GII.4 (50/50) - MPL (15)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)3212.2 titerStandard Deviation 2.44
GI.1/GII.4 (50/50) - MPL (15)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)1130.9 titerStandard Deviation 4.18
GI.1/GII.4 (50/50) - MPL (15)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)1097.8 titerStandard Deviation 4.14
GI.1/GII.4 (50/50) - MPL (15)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)7802.7 titerStandard Deviation 2.03
GI.1/GII.4 (15/15)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)2267.2 titerStandard Deviation 3.29
GI.1/GII.4 (15/15)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)3444.6 titerStandard Deviation 2.92
GI.1/GII.4 (15/15)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)1340.4 titerStandard Deviation 4.08
GI.1/GII.4 (15/15)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)2251.1 titerStandard Deviation 3.15
GI.1/GII.4 (15/15)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)1268.1 titerStandard Deviation 3.68
GI.1/GII.4 (15/50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)1311.0 titerStandard Deviation 3.98
GI.1/GII.4 (15/50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)1238.6 titerStandard Deviation 3.92
GI.1/GII.4 (15/50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)2969.9 titerStandard Deviation 2.92
GI.1/GII.4 (15/50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)9945.7 titerStandard Deviation 2.98
GI.1/GII.4 (15/50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)5017.6 titerStandard Deviation 2.82
GI.1/GII.4 (50/50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)2615.1 titerStandard Deviation 2.91
GI.1/GII.4 (50/50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)1139.9 titerStandard Deviation 3.48
GI.1/GII.4 (50/50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)1898.2 titerStandard Deviation 3.41
GI.1/GII.4 (50/50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)1201.2 titerStandard Deviation 3.57
GI.1/GII.4 (50/50)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)5129.9 titerStandard Deviation 2.91
GI.1/GII.4 (50/150)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)2550.0 titerStandard Deviation 2.29
GI.1/GII.4 (50/150)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)1473.2 titerStandard Deviation 3.88
GI.1/GII.4 (50/150)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)1494.7 titerStandard Deviation 3.05
GI.1/GII.4 (50/150)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)10624.2 titerStandard Deviation 2.15
GI.1/GII.4 (50/150)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)4531.4 titerStandard Deviation 2.21
GI.1/GII.4 (15/50) - Al(OH)3 (167)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)1832.3 titerStandard Deviation 2.69
GI.1/GII.4 (15/50) - Al(OH)3 (167)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)4667.0 titerStandard Deviation 2.2
GI.1/GII.4 (15/50) - Al(OH)3 (167)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)2871.1 titerStandard Deviation 2.43
GI.1/GII.4 (15/50) - Al(OH)3 (167)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)1924.8 titerStandard Deviation 2.52
GI.1/GII.4 (15/50) - Al(OH)3 (167)Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)10034.2 titerStandard Deviation 1.96
GI.1/GII.4 (15/50) x2Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)3837.9 titerStandard Deviation 2.3
GI.1/GII.4 (15/50) x2Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)2425.1 titerStandard Deviation 2.46
GI.1/GII.4 (15/50) x2Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)977.7 titerStandard Deviation 3.73
GI.1/GII.4 (15/50) x2Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)8459.4 titerStandard Deviation 2.19
GI.1/GII.4 (15/50) x2Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)6622.0 titerStandard Deviation 2.22
GI.1/GII.4 (50/150) x2Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)9995.5 titerStandard Deviation 2.13
GI.1/GII.4 (50/150) x2Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)4693.8 titerStandard Deviation 2.52
GI.1/GII.4 (50/150) x2Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)12901.7 titerStandard Deviation 2.12
GI.1/GII.4 (50/150) x2Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)1324.4 titerStandard Deviation 3.34
GI.1/GII.4 (50/150) x2Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)3133.0 titerStandard Deviation 2.5
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)11116.3 titerStandard Deviation 2.55
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)4546.8 titerStandard Deviation 2.26
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)3060.7 titerStandard Deviation 2.44
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)8164.0 titerStandard Deviation 2.32
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)1647.0 titerStandard Deviation 3.39
Secondary

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

GMFR of anti-norovirus GII.4 Cincinnati antibody titers as measured by HBGA binding assay. D=Day

Time frame: Days 28, 56, 208 and 393

Population: 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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
GI.1/GII.4 (15/15) - MPL (50)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/15) - MPL (50)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)3.4 titerStandard Deviation 2.91
GI.1/GII.4 (15/15) - MPL (50)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/15) - MPL (50)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 titerStandard Deviation 1.17
GI.1/GII.4 (15/50) - MPL (50)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) - MPL (50)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) - MPL (50)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)5.1 titerStandard Deviation 2.78
GI.1/GII.4 (15/50) - MPL (50)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 titerStandard Deviation 1.18
GI.1/GII.4 (50/50) - MPL (50)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/50) - MPL (50)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0.9 titerStandard Deviation 1.12
GI.1/GII.4 (50/50) - MPL (50)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)1.7 titerStandard Deviation 1.81
GI.1/GII.4 (50/50) - MPL (50)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/15) - MPL (15)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 titerStandard Deviation 1.22
GI.1/GII.4 (15/15) - MPL (15)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/15) - MPL (15)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)2.6 titerStandard Deviation 2.78
GI.1/GII.4 (15/15) - MPL (15)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) - MPL (15)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)1.4 titerStandard Deviation 2.08
GI.1/GII.4 (15/50) - MPL (15)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)4.2 titerStandard Deviation 3.2
GI.1/GII.4 (15/50) - MPL (15)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)1.8 titerStandard Deviation 2.34
GI.1/GII.4 (15/50) - MPL (15)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 titerStandard Deviation 1.11
GI.1/GII.4 (50/50) - MPL (15)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/50) - MPL (15)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0.9 titerStandard Deviation 1.22
GI.1/GII.4 (50/50) - MPL (15)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/50) - MPL (15)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)3.7 titerStandard Deviation 3.17
GI.1/GII.4 (15/15)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/15)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/15)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)1.6 titerStandard Deviation 2.06
GI.1/GII.4 (15/15)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0.9 titerStandard Deviation 1.18
GI.1/GII.4 (15/50)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)2.4 titerStandard Deviation 2.89
GI.1/GII.4 (15/50)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 titerStandard Deviation 1.67
GI.1/GII.4 (15/50)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)5.9 titerStandard Deviation 4.17
GI.1/GII.4 (15/50)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)1.9 titerStandard Deviation 2.56
GI.1/GII.4 (50/50)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/50)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/50)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0.9 titerStandard Deviation 1.98
GI.1/GII.4 (50/50)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)2.7 titerStandard Deviation 3.16
GI.1/GII.4 (50/150)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 titerStandard Deviation 1.12
GI.1/GII.4 (50/150)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/150)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)4.6 titerStandard Deviation 2.73
GI.1/GII.4 (50/150)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) - Al(OH)3 (167)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) - Al(OH)3 (167)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) - Al(OH)3 (167)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)3.1 titerStandard Deviation 2.36
GI.1/GII.4 (15/50) - Al(OH)3 (167)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 titerStandard Deviation 1.13
GI.1/GII.4 (15/50) x2GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)4.6 titerStandard Deviation 2.94
GI.1/GII.4 (15/50) x2GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) x2GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) x2GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)7.4 titerStandard Deviation 2.97
GI.1/GII.4 (50/150) x2GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)3.6 titerStandard Deviation 2.62
GI.1/GII.4 (50/150) x2GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/150) x2GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)4.5 titerStandard Deviation 2.94
GI.1/GII.4 (50/150) x2GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)5.7 titerStandard Deviation 3.01
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)4.0 titerStandard Deviation 2.45
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
Secondary

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

GMFR of anti-norovirus GII.4 Sydney antibody titers as measured by HBGA binding assay. D=Day

Time frame: Days 28, 56, 208 and 393

Population: 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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
GI.1/GII.4 (15/15) - MPL (50)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/15) - MPL (50)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)1.5 titerStandard Deviation 2.59
GI.1/GII.4 (15/15) - MPL (50)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/15) - MPL (50)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0.9 titerStandard Deviation 1.22
GI.1/GII.4 (15/50) - MPL (50)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) - MPL (50)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) - MPL (50)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)2.3 titerStandard Deviation 2.1
GI.1/GII.4 (15/50) - MPL (50)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 titerStandard Deviation 1.26
GI.1/GII.4 (50/50) - MPL (50)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/50) - MPL (50)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0.9 titerStandard Deviation 1.12
GI.1/GII.4 (50/50) - MPL (50)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)1.3 titerStandard Deviation 1.67
GI.1/GII.4 (50/50) - MPL (50)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/15) - MPL (15)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 titerStandard Deviation 1.18
GI.1/GII.4 (15/15) - MPL (15)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/15) - MPL (15)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)1.3 titerStandard Deviation 1.48
GI.1/GII.4 (15/15) - MPL (15)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) - MPL (15)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)1.0 titerStandard Deviation 1.78
GI.1/GII.4 (15/50) - MPL (15)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)2.0 titerStandard Deviation 2.46
GI.1/GII.4 (15/50) - MPL (15)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)1.4 titerStandard Deviation 1.93
GI.1/GII.4 (15/50) - MPL (15)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0.9 titerStandard Deviation 1.22
GI.1/GII.4 (50/50) - MPL (15)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/50) - MPL (15)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 titerStandard Deviation 1.09
GI.1/GII.4 (50/50) - MPL (15)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/50) - MPL (15)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)1.7 titerStandard Deviation 1.82
GI.1/GII.4 (15/15)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/15)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/15)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)1.1 titerStandard Deviation 1.6
GI.1/GII.4 (15/15)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0.9 titerStandard Deviation 1.47
GI.1/GII.4 (15/50)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)1.6 titerStandard Deviation 2.1
GI.1/GII.4 (15/50)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.1 titerStandard Deviation 1.91
GI.1/GII.4 (15/50)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)2.9 titerStandard Deviation 3.5
GI.1/GII.4 (15/50)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)1.4 titerStandard Deviation 2.28
GI.1/GII.4 (50/50)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/50)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/50)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 titerStandard Deviation 1.05
GI.1/GII.4 (50/50)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)1.6 titerStandard Deviation 1.77
GI.1/GII.4 (50/150)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 titerStandard Deviation 1.25
GI.1/GII.4 (50/150)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/150)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)2.5 titerStandard Deviation 2.62
GI.1/GII.4 (50/150)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) - Al(OH)3 (167)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) - Al(OH)3 (167)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) - Al(OH)3 (167)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)2.0 titerStandard Deviation 2.02
GI.1/GII.4 (15/50) - Al(OH)3 (167)GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 titerStandard Deviation 1.06
GI.1/GII.4 (15/50) x2GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)1.8 titerStandard Deviation 2.25
GI.1/GII.4 (15/50) x2GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) x2GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) x2GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)2.2 titerStandard Deviation 2.48
GI.1/GII.4 (50/150) x2GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)1.9 titerStandard Deviation 2.3
GI.1/GII.4 (50/150) x2GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (50/150) x2GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)2.5 titerStandard Deviation 2.8
GI.1/GII.4 (50/150) x2GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)2.8 titerStandard Deviation 2.77
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)2.1 titerStandard Deviation 2.25
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA titer—
Secondary

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

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

Time frame: Day 56

Population: 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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)Dispersion
GI.1/GII.4 (15/15) - MPL (50)GMFR of Antibody Titers of Strains Not Represented in the Investigational Vaccine: Cross-Protection AssaysGII.2 EC501.1 titerStandard Deviation 1.92
GI.1/GII.4 (15/15) - MPL (50)GMFR of Antibody Titers of Strains Not Represented in the Investigational Vaccine: Cross-Protection AssaysGI.3 EC505.9 titerStandard Deviation 3.23
GI.1/GII.4 (15/15) - MPL (50)GMFR of Antibody Titers of Strains Not Represented in the Investigational Vaccine: Cross-Protection AssaysGII.4.2012 EC503.2 titerStandard Deviation 2.5
GI.1/GII.4 (15/50) - MPL (50)GMFR of Antibody Titers of Strains Not Represented in the Investigational Vaccine: Cross-Protection AssaysGII.2 EC500.8 titerStandard Deviation 3.73
GI.1/GII.4 (15/50) - MPL (50)GMFR of Antibody Titers of Strains Not Represented in the Investigational Vaccine: Cross-Protection AssaysGI.3 EC503.0 titerStandard Deviation 3.36
GI.1/GII.4 (15/50) - MPL (50)GMFR of Antibody Titers of Strains Not Represented in the Investigational Vaccine: Cross-Protection AssaysGII.4.2012 EC504.1 titerStandard Deviation 3.51
Secondary

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

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

Time frame: Baseline and Days 28, 56, 208 and 393

Population: 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.

ArmMeasureGroupValue (NUMBER)
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)80.0 percentage of participants
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)55.2 percentage of participants
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)60.0 percentage of participants
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)89.7 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)46.4 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)65.5 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)67.9 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)100.0 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)67.9 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)69.0 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)89.7 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)72.4 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)6.9 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)63.3 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)93.3 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)70.0 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)73.3 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)96.8 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)65.5 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)86.7 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)55.2 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)66.7 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)87.5 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)53.1 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)62.5 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)85.7 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)82.1 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)92.9 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)90.0 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)60.0 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)43.3 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)54.2 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)83.3 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)4.2 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)45.8 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)85.7 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)64.3 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)85.7 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)71.4 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)75.9 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)96.6 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)72.4 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)93.1 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)93.3 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)86.7 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)78.6 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)74.1 percentage of participants
Secondary

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

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

Time frame: Baseline and Days 28, 56, 208 and 393

Population: 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.

ArmMeasureGroupValue (NUMBER)
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)50.0 percentage of participants
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)20.7 percentage of participants
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)16.7 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)27.6 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)32.1 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)65.5 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)46.4 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)7.1 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)10.7 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)41.4 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)27.6 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)27.6 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)83.3 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)20.0 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)36.7 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)71.0 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)23.3 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)17.2 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)16.7 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)3.3 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)33.3 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)17.2 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)71.9 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)3.1 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)21.9 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)46.9 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)10.7 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)42.9 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)14.3 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)13.3 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)73.3 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)3.3 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)30.0 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)54.2 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)16.7 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)8.3 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)78.6 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)78.6 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)35.7 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)28.6 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)27.6 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)72.4 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)41.4 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)86.2 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)21.4 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)63.3 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)70.0 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)33.3 percentage of participants
Secondary

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

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

Time frame: Baseline and Days 28, 56, 208 and 393

Population: 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.

ArmMeasureGroupValue (NUMBER)
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)0 percentage of participants
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)33.3 percentage of participants
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,28)10.0 percentage of participants
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,28)3.4 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,28)13.8 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)0 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)55.2 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,28)20.7 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,28)6.7 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)0 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,28)16.7 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)32.1 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)0 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,28)3.2 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,28)6.5 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)35.5 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,28)6.7 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)66.7 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)0 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,28)13.3 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)51.6 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)0 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,28)13.3 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,28)3.4 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,28)6.9 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,28)20.0 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)26.7 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)0 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,28)9.4 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)0 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,28)31.3 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)59.4 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)28.6 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)0 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,28)3.4 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,28)20.7 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)60.0 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,28)16.7 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)0 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,28)3.3 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,28)3.7 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)0 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,28)7.4 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)53.8 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)75.0 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,28)7.1 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)67.9 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,28)42.9 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,28)34.5 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,28)10.3 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)62.1 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)58.6 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)56.7 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,28)7.1 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,28)21.4 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)67.7 percentage of participants
Secondary

Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA 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 as measured by immunoglobulin A (IgA) enzyme-linked immunosorbent assay (ELISA) for all arms on day 28 and day 56 and for selected arms on day 208 and day 393. D=Day

Time frame: Baseline and Days 28, 56, 208 and 393

Population: 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.

ArmMeasureGroupValue (NUMBER)
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)0 percentage of participants
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)53.3 percentage of participants
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)0 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)58.6 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)39.3 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)0 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)0 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)45.2 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)13.3 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)30.0 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)0 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)70.0 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)0 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)58.1 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)3.03 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)36.7 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)0 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)65.6 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)25.0 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)6.5 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)42.9 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)0 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)0 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)66.7 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)50.0 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)0 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)57.1 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)71.4 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)51.7 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)72.4 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)64.5 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)46.7 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA percentage of participants
Secondary

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

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

Time frame: Baseline and Days 28, 56, 208 and 393

Population: 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.

ArmMeasureGroupValue (NUMBER)
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)31.0 percentage of participants
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)53.3 percentage of participants
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)80.0 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)32.1 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)79.3 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)65.5 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)67.9 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)85.7 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)50.0 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)37.9 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)58.6 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)82.8 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)86.7 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)23.3 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)43.3 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)37.9 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)70.0 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)87.1 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)76.7 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)60.0 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)44.8 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)53.1 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)78.1 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)78.1 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)53.6 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)82.1 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)85.7 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)90.0 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)26.7 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)56.7 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)70.8 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)33.3 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)29.2 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)82.1 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)85.7 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)100.0 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)50.0 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)96.6 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)96.6 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)51.7 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)93.1 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)77.8 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)93.3 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)93.3 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)46.4 percentage of participants
Secondary

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

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 and for selected arms on day 208 and day 393. D=Day

Time frame: Baseline and Days 28, 56, 208 and 393

Population: 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.

ArmMeasureGroupValue (NUMBER)
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)93.3 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)89.7 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)100.0 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)6.9 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)89.7 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)73.3 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)96.7 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)80.0 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)100.0 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)90.0 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)3.3 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)71.9 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)90.6 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)54.8 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)96.4 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)100.0 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)87.5 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)4.2 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)96.4 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)96.4 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)100.0 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)100.0 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)100.0 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)100.0 percentage of participants
Secondary

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

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

Time frame: Baseline and Days 28, 56, 208 and 393

Population: 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.

ArmMeasureGroupValue (NUMBER)
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)26.7 percentage of participants
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)13.8 percentage of participants
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)3.3 percentage of participants
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)46.7 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)21.4 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)31.0 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)72.4 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)17.9 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)3.6 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)3.7 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)39.3 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)17.2 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)20.7 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)41.4 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)23.3 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)3.3 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)80.0 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)43.3 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)20.0 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)61.3 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)3.4 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)26.7 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)10.3 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)20.0 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)43.8 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)3.1 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)71.9 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)12.5 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)21.4 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)10.7 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)3.7 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)35.7 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)3.3 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)16.7 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)63.3 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)33.3 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)25.0 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)4.2 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)66.7 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)75.0 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)21.4 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)50.0 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)82.1 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)58.6 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)37.9 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)65.5 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)24.1 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)70.0 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)22.2 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)60.0 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)10.7 percentage of participants
Secondary

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

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 and for selected arms on day 208 and day 393. D=Day

Time frame: Baseline and Days 28, 56, 208 and 393

Population: 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.

ArmMeasureGroupValue (NUMBER)
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)53.3 percentage of participants
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)65.5 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)39.3 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)51.7 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)36.7 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)73.3 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)23.3 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)58.1 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)36.7 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)3.3 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)34.4 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)3.1 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)68.8 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)16.1 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)46.4 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)3.3 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)66.7 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)54.2 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)75.0 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)60.7 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)72.4 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)51.7 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)63.3 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)46.7 percentage of participants
Secondary

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

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.

Time frame: Day 1 up to Day 56

Population: Safety Analysis Set included all participants who received at least one dose of trial vaccine.

ArmMeasureValue (NUMBER)
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With Any Adverse Event (AE) Leading to Withdrawal From the Study0 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With Any Adverse Event (AE) Leading to Withdrawal From the Study0 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With Any Adverse Event (AE) Leading to Withdrawal From the Study0 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With Any Adverse Event (AE) Leading to Withdrawal From the Study0 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With Any Adverse Event (AE) Leading to Withdrawal From the Study0 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With Any Adverse Event (AE) Leading to Withdrawal From the Study0 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With Any Adverse Event (AE) Leading to Withdrawal From the Study0 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With Any Adverse Event (AE) Leading to Withdrawal From the Study0 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With Any Adverse Event (AE) Leading to Withdrawal From the Study0 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With Any Adverse Event (AE) Leading to Withdrawal From the Study0 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With Any Adverse Event (AE) Leading to Withdrawal From the Study0 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With Any Adverse Event (AE) Leading to Withdrawal From the Study0 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With Any Adverse Event (AE) Leading to Withdrawal From the Study0 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With Any Adverse Event (AE) Leading to Withdrawal From the Study0 percentage of participants
Secondary

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

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

Time frame: Baseline and Days 28, 208 and 393

Population: 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.

ArmMeasureGroupValue (NUMBER)
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)0 percentage of participants
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)17.2 percentage of participants
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,28)10.0 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)20.7 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)0 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,28)17.2 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)13.3 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)0 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,28)10.0 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,28)19.4 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)0 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)16.1 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)10.0 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)0 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,28)20.0 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)0 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,28)20.0 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)13.8 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)10.3 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)0 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,28)6.7 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,28)34.4 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)0 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)15.6 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,28)17.2 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)6.9 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)0 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,28)23.3 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)0 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)13.3 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,28)14.8 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)7.4 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)0 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,28)32.1 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)71.4 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)21.4 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)79.3 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)20.7 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,28)34.5 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)20.7 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,28)35.7 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)67.7 percentage of participants
Secondary

Percentage of Participants With Significant New Medical Conditions

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.

Time frame: Day 1 up to Day 56

Population: Safety Analysis Set included all participants who received at least one dose of trial vaccine.

ArmMeasureGroupValue (NUMBER)
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With Significant New Medical ConditionsIMEs0 percentage of participants
GI.1/GII.4 (15/15) - MPL (50)Percentage of Participants With Significant New Medical ConditionsAESIs6.7 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With Significant New Medical ConditionsIMEs0 percentage of participants
GI.1/GII.4 (15/50) - MPL (50)Percentage of Participants With Significant New Medical ConditionsAESIs3.3 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With Significant New Medical ConditionsAESIs0 percentage of participants
GI.1/GII.4 (50/50) - MPL (50)Percentage of Participants With Significant New Medical ConditionsIMEs0 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With Significant New Medical ConditionsIMEs0 percentage of participants
GI.1/GII.4 (15/15) - MPL (15)Percentage of Participants With Significant New Medical ConditionsAESIs6.5 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With Significant New Medical ConditionsAESIs0 percentage of participants
GI.1/GII.4 (15/50) - MPL (15)Percentage of Participants With Significant New Medical ConditionsIMEs0 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With Significant New Medical ConditionsAESIs0 percentage of participants
GI.1/GII.4 (50/50) - MPL (15)Percentage of Participants With Significant New Medical ConditionsIMEs0 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With Significant New Medical ConditionsIMEs0 percentage of participants
GI.1/GII.4 (15/15)Percentage of Participants With Significant New Medical ConditionsAESIs6.7 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With Significant New Medical ConditionsAESIs6.3 percentage of participants
GI.1/GII.4 (15/50)Percentage of Participants With Significant New Medical ConditionsIMEs0 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With Significant New Medical ConditionsIMEs0 percentage of participants
GI.1/GII.4 (50/50)Percentage of Participants With Significant New Medical ConditionsAESIs0 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With Significant New Medical ConditionsIMEs0 percentage of participants
GI.1/GII.4 (50/150)Percentage of Participants With Significant New Medical ConditionsAESIs0 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With Significant New Medical ConditionsIMEs0 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167)Percentage of Participants With Significant New Medical ConditionsAESIs0 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With Significant New Medical ConditionsIMEs0 percentage of participants
GI.1/GII.4 (15/50) x2Percentage of Participants With Significant New Medical ConditionsAESIs7.1 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With Significant New Medical ConditionsIMEs0 percentage of participants
GI.1/GII.4 (50/150) x2Percentage of Participants With Significant New Medical ConditionsAESIs3.4 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With Significant New Medical ConditionsIMEs0 percentage of participants
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Percentage of Participants With Significant New Medical ConditionsAESIs0 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026