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CompletedNCT02038907NOR-107Updated Aug 8, 2017Results posted

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

A Phase 2 interventional study of Hepatitis A Vaccine and Norovirus Bivalent VLP Vaccine in Healthy Volunteers and Norovirus, Prevention, sponsored by Takeda. Completed at 2 sites in Belgium. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-08.

Sponsored by Takeda · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
420
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Healthy Volunteers
  • Norovirus, Prevention

Keywords

  • Norovirus, vaccination
03

In context

Lead sponsor

Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.

Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
420 participants (actual)

Study arms

  • Experimental
    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.

    Biological: Hepatitis A Vaccine · Biological: Norovirus Bivalent VLP Vaccine

  • Experimental
    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.

    Biological: Hepatitis A Vaccine · Biological: Norovirus Bivalent VLP Vaccine

  • Experimental
    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.

    Biological: Hepatitis A Vaccine · Biological: Norovirus Bivalent VLP Vaccine

  • Experimental
    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.

    Biological: Hepatitis A Vaccine · Biological: Norovirus Bivalent VLP Vaccine

  • Experimental
    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.

    Biological: Hepatitis A Vaccine · Biological: Norovirus Bivalent VLP Vaccine

  • Experimental
    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.

    Biological: Hepatitis A Vaccine · Biological: Norovirus Bivalent VLP Vaccine

  • Experimental
    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.

    Biological: Hepatitis A Vaccine · Biological: Norovirus Bivalent VLP Vaccine

  • Experimental
    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.

    Biological: Hepatitis A Vaccine · Biological: Norovirus Bivalent VLP Vaccine

  • Experimental
    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.

    Biological: Hepatitis A Vaccine · Biological: Norovirus Bivalent VLP Vaccine

  • Experimental
    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.

    Biological: Hepatitis A Vaccine · Biological: Norovirus Bivalent VLP Vaccine

  • Experimental
    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.

    Biological: Hepatitis A Vaccine · Biological: Norovirus Bivalent VLP Vaccine

  • Experimental
    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.

    Biological: Norovirus Bivalent VLP Vaccine

  • Experimental
    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.

    Biological: Norovirus Bivalent VLP Vaccine

  • Experimental
    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.

    Biological: Norovirus Bivalent VLP Vaccine

Interventions

  • BiologicalHepatitis A Vaccine

    Hepatitis A Vaccine IM injection

    Also known as: Havrix

  • BiologicalNorovirus Bivalent VLP Vaccine

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

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

  31. 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

07

Results

Posted Aug 1, 2016

Participant flow

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.

Participant flow — Overall Study
MilestoneGI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Started3030303130313032293029282931
Completed3030303130313032293027282931
Not completed00000000002000
Withdrew: Protocol violation00000000001000
Withdrew: Withdrawal by subject00000000001000

Outcome measures

PrimaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With a Seroresponse (Pan-Ig ELISA)
percentage of participantsGI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Percentage of Participants With a Seroresponse (Pan-Ig ELISA)43.3 (25.5 to 62.6)62.1 (42.3 to 79.3)46.4 (27.5 to 66.1)35.5 (19.2 to 54.6)80.0 (61.4 to 92.3)67.7 (48.6 to 83.3)30.0 (14.7 to 49.4)62.5 (43.7 to 78.9)42.9 (24.5 to 62.8)66.7 (47.2 to 82.7)46.2 (26.6 to 66.6)71.4 (51.3 to 86.8)69.0 (49.2 to 84.7)56.7 (37.4 to 74.5)
PrimaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1
percentage of participantsGI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Pain43.333.350.032.346.738.740.053.144.853.348.346.431.032.3
Erythema00000000000000
Induration00000000000000
Swelling000000003.400000
PrimaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2
percentage of participantsGI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Pain60.036.766.751.653.358.133.343.848.346.734.532.141.435.5
Erythema003.3000003.43.30000
Induration003.306.70003.43.30000
Swelling03.303.203.2006.900000
PrimaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1
percentage of participantsGI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Headache20.026.73.319.416.712.913.325.027.620.013.817.931.019.4
Fatigue23.323.316.719.410.012.913.315.617.220.024.125.017.222.6
Myalgia20.06.713.36.53.39.76.718.810.310.017.210.73.419.4
Arthralgia03.36.703.303.36.36.93.33.43.63.43.2
Vomiting03.30003.20003.33.4000
Diarrhea023.33.316.120.06.513.312.513.810.06.97.110.312.9
PrimaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2
percentage of participantsGI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Headache13.313.313.322.623.316.110.021.920.710.013.814.334.519.4
Fatigue16.713.320.012.910.012.910.018.817.213.313.87.113.812.9
Myalgia13.33.313.3013.312.906.36.9010.37.106.5
Arthralgia03.33.303.33.203.103.33.43.603.2
Vomiting0000000003.33.4000
Diarrhea3.310.016.712.916.79.76.715.617.210.03.47.16.93.2
PrimaryOral 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
Reported as:
Mean · degrees Celsius
Oral Body Temperature Within 7 Days After Dose 1
degrees CelsiusGI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Oral Body Temperature Within 7 Days After Dose 136.54 ± 0.29436.76 ± 0.37636.66 ± 0.34536.71 ± 0.26036.65 ± 0.38836.67 ± 0.25536.74 ± 0.32336.63 ± 0.36636.52 ± 0.40536.77 ± 0.34136.71 ± 0.40436.61 ± 0.36836.70 ± 0.36236.61 ± 0.381
PrimaryOral 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
Reported as:
Mean · degrees Celsius
Oral Body Temperature Within 7 Days After Dose 2
degrees CelsiusGI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Oral Body Temperature Within 7 Days After Dose 236.54 ± 0.28236.76 ± 0.30136.68 ± 0.35136.75 ± 0.46636.60 ± 0.28636.72 ± 0.31736.71 ± 0.39436.64 ± 0.34236.59 ± 0.46336.73 ± 0.29336.68 ± 0.34536.56 ± 0.35136.76 ± 0.39136.61 ± 0.386
PrimaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With Unsolicited Adverse Events (AEs)
percentage of participantsGI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Percentage of Participants With Unsolicited Adverse Events (AEs)56.760.053.345.243.354.843.362.569.043.348.350.051.761.3
PrimaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With Serious Adverse Events (SAEs)
percentage of participantsGI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Percentage of Participants With Serious Adverse Events (SAEs)6.7016.76.53.3010.09.43.43.33.47.13.43.2
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)
percentage of participantsGI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)0 (0.0 to 11.6)0 (0.0 to 11.6)0 (0.0 to 11.9)0 (0.0 to 11.2)0 (0.0 to 11.6)0 (0.0 to 11.2)0 (0.0 to 11.6)0 (0.0 to 10.9)0 (0.0 to 12.3)0 (0.0 to 11.6)0 (0.0 to 12.8)71.4 (51.3 to 86.8)79.3 (60.3 to 92.0)67.7 (48.6 to 83.3)
D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,28)10.0 (2.1 to 26.5)17.2 (5.8 to 35.8)10.0 (2.1 to 26.5)19.4 (7.5 to 37.5)20.0 (7.7 to 38.6)20.0 (7.7 to 38.6)6.7 (0.8 to 22.1)34.4 (18.6 to 53.2)17.2 (5.8 to 35.8)23.3 (9.9 to 42.3)14.8 (4.2 to 33.7)32.1 (15.9 to 52.4)34.5 (17.9 to 54.3)35.7 (18.6 to 55.9)
D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)17.2 (5.8 to 35.8)20.7 (8.0 to 39.7)13.3 (3.8 to 30.7)16.1 (5.5 to 33.7)10.0 (2.1 to 26.5)13.8 (3.9 to 31.7)10.3 (2.2 to 27.4)15.6 (5.3 to 32.8)6.9 (0.8 to 22.8)13.3 (3.8 to 30.7)7.4 (0.9 to 24.3)21.4 (8.3 to 41.0)20.7 (8.0 to 39.7)20.7 (8.0 to 39.7)
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)
percentage of participantsGI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 (0.0 to 11.6)0 (0.0 to 11.9)0 (0.0 to 12.8)6.9 (0.8 to 22.8)0 (0.0 to 11.6)0 (0.0 to 11.2)0 (0.0 to 11.6)0 (0.0 to 10.9)0 (0.0 to 12.8)0 (0.0 to 11.6)4.2 (0.1 to 21.1)85.7 (67.3 to 96.0)93.1 (77.2 to 99.2)93.3 (77.9 to 99.2)
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)80.0 (61.4 to 92.3)89.7 (72.6 to 97.8)100.0 (87.7 to 100.0)89.7 (72.6 to 97.8)93.3 (77.9 to 99.2)96.8 (83.3 to 99.9)86.7 (69.3 to 96.2)87.5 (71.0 to 96.5)92.9 (76.5 to 99.1)90.0 (73.5 to 97.9)83.3 (62.6 to 95.3)85.7 (67.3 to 96.0)96.6 (82.2 to 99.9)86.7 (69.3 to 96.2)
D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)60.0 (40.6 to 77.3)65.5 (45.7 to 82.1)67.9 (47.6 to 84.1)72.4 (52.8 to 87.3)70.0 (50.6 to 85.3)73.3 (54.1 to 87.7)66.7 (47.2 to 82.7)62.5 (43.7 to 78.9)85.7 (67.3 to 96.0)60.0 (40.6 to 77.3)54.2 (32.8 to 74.4)71.4 (51.3 to 86.8)75.9 (56.5 to 89.7)74.1 (53.7 to 88.9)
D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)55.2 (35.7 to 73.6)46.4 (27.5 to 66.1)67.9 (47.6 to 84.1)69.0 (49.2 to 84.7)63.3 (43.9 to 80.1)65.5 (45.7 to 82.1)55.2 (35.7 to 73.6)53.1 (34.7 to 70.9)82.1 (63.1 to 93.9)43.3 (25.5 to 62.6)45.8 (25.6 to 67.2)64.3 (44.1 to 81.4)72.4 (52.8 to 87.3)78.6 (59.0 to 91.7)
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA)
percentage of participantsGI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 (0.0 to 11.6)0 (0.0 to 11.9)0 (0.0 to 12.8)0 (0.0 to 11.9)0 (0.0 to 11.6)0 (0.0 to 11.2)3.3 (0.1 to 17.2)3.1 (0.1 to 16.2)0 (0.0 to 12.8)3.3 (0.1 to 17.2)0 (0.0 to 14.2)78.6 (59.0 to 91.7)86.2 (68.3 to 96.1)70.0 (50.6 to 85.3)
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)50.0 (31.3 to 68.7)65.5 (45.7 to 82.1)46.4 (27.5 to 66.1)41.4 (23.5 to 61.1)83.3 (65.3 to 94.4)71.0 (52.0 to 85.8)33.3 (17.3 to 52.8)71.9 (53.3 to 86.3)42.9 (24.5 to 62.8)73.3 (54.1 to 87.7)54.2 (32.8 to 74.4)78.6 (59.0 to 91.7)72.4 (52.8 to 87.3)63.3 (43.9 to 80.1)
D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)16.7 (5.6 to 34.7)27.6 (12.7 to 47.2)7.1 (0.9 to 23.5)27.6 (12.7 to 47.2)36.7 (19.9 to 56.1)23.3 (9.9 to 42.3)16.7 (5.6 to 34.7)46.9 (29.1 to 65.3)14.3 (4.0 to 32.7)30.0 (14.7 to 49.4)16.7 (4.7 to 37.4)35.7 (18.6 to 55.9)41.4 (23.5 to 61.1)33.3 (16.5 to 54.0)
D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)20.7 (8.0 to 39.7)32.1 (15.9 to 52.4)10.7 (2.3 to 28.2)27.6 (12.7 to 47.2)20.0 (7.7 to 38.6)17.2 (5.8 to 35.8)17.2 (5.8 to 35.8)21.9 (9.3 to 40.0)10.7 (2.3 to 28.2)13.3 (3.8 to 30.7)8.3 (1.0 to 27.0)28.6 (13.2 to 48.7)27.6 (12.7 to 47.2)21.4 (8.3 to 41.0)
SecondaryGeometric 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
Reported as:
Geometric mean · titer
Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)
titerGI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)833.4 ± 4.64790.3 ± 4.50636.7 ± 4.60647.6 ± 5.17625.3 ± 2.96520.3 ± 4.99890.5 ± 4.75842.9 ± 4.92677.2 ± 3.75827.3 ± 4.82856.7 ± 5.34741.5 ± 5.28897.5 ± 3.74742.7 ± 3.69
D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)798.9 ± 4.66737.9 ± 4.42548.5 ± 4.47806.6 ± 5.36573.6 ± 3.08514.6 ± 5.19910.4 ± 4.37821.5 ± 4.84638.5 ± 3.90780.6 ± 5.11889.7 ± 5.3414488.6 ± 3.0020839.2 ± 1.9615967.7 ± 2.39
D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)14417.7 ± 2.7414171.3 ± 2.7617504.8 ± 2.6414220.4 ± 3.2313982.2 ± 2.3318266.0 ± 1.9916082.5 ± 2.0715974.2 ± 3.9525808.9 ± 2.5515466.3 ± 2.5914045.2 ± 2.9412613.2 ± 2.4617696.3 ± 1.9212235.7 ± 2.11
D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)5725.2 ± 2.375069.7 ± 2.486084.3 ± 2.435613.9 ± 2.684467.6 ± 2.055106.4 ± 2.065660.5 ± 2.227174.8 ± 2.477542.0 ± 2.285361.1 ± 2.375162.8 ± 2.186863.9 ± 2.277459.1 ± 1.725912.6 ± 1.94
D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)3886.0 ± 2.983179.7 ± 2.784470.4 ± 2.555009.0 ± 2.803209.6 ± 2.543874.5 ± 2.554940.3 ± 2.484773.3 ± 2.625550.1 ± 2.703542.9 ± 2.543960.0 ± 2.554715.8 ± 2.515686.7 ± 2.174404.7 ± 2.19
SecondaryGeometric 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
Reported as:
Geometric mean · titer
Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)
titerGI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)1106.6 ± 4.681249.2 ± 3.451477.7 ± 4.131109.2 ± 4.10921.7 ± 3.151130.9 ± 4.181340.4 ± 4.081238.6 ± 3.921201.2 ± 3.571473.2 ± 3.881832.3 ± 2.69977.7 ± 3.731324.4 ± 3.341647.0 ± 3.39
D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)1016.8 ± 5.561232.6 ± 3.461540.6 ± 3.831110.4 ± 3.84839.4 ± 3.041097.8 ± 4.141268.1 ± 3.681311.0 ± 3.981139.9 ± 3.481494.7 ± 3.051924.8 ± 2.528459.4 ± 2.1912901.7 ± 2.1211116.3 ± 2.55
D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)4595.7 ± 3.008636.7 ± 2.055750.4 ± 2.154391.5 ± 2.667545.2 ± 2.617802.7 ± 2.033444.6 ± 2.929945.7 ± 2.985129.9 ± 2.9110624.2 ± 2.1510034.2 ± 1.966622.0 ± 2.229995.5 ± 2.138164.0 ± 2.32
D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)2341.2 ± 3.933653.0 ± 2.242993.2 ± 3.612887.7 ± 2.782984.6 ± 2.623212.2 ± 2.442251.1 ± 3.155017.6 ± 2.822615.1 ± 2.914531.4 ± 2.214667.0 ± 2.203837.9 ± 2.304693.8 ± 2.524546.8 ± 2.26
D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)2236.5 ± 3.843103.0 ± 3.032450.2 ± 2.872175.3 ± 2.911946.4 ± 2.512173.7 ± 2.732267.2 ± 3.292969.9 ± 2.921898.2 ± 3.412550.0 ± 2.292871.1 ± 2.432425.1 ± 2.463133.0 ± 2.503060.7 ± 2.44
SecondaryGeometric 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
Reported as:
Geometric mean · ratio
Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)
ratioGI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 ± 1.130.9 ± 1.180.8 ± 1.501.2 ± 2.850.9 ± 1.261.0 ± 1.161.0 ± 1.361.0 ± 1.180.9 ± 1.280.9 ± 1.281.0 ± 1.5819.5 ± 3.7323.2 ± 3.0022.0 ± 2.57
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)17.3 ± 3.6918.8 ± 3.4625.8 ± 3.0922.4 ± 4.3822.4 ± 3.0235.1 ± 3.8818.1 ± 4.3519.0 ± 3.6736.5 ± 4.8518.7 ± 3.3113.5 ± 3.0717.0 ± 3.6319.7 ± 2.7816.8 ± 2.74
D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)6.9 ± 3.636.7 ± 3.719.3 ± 3.779.0 ± 4.327.1 ± 2.6310.4 ± 3.796.4 ± 3.628.5 ± 3.9010.7 ± 3.006.5 ± 2.965.2 ± 3.279.3 ± 3.578.3 ± 2.797.8 ± 3.52
D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)4.4 ± 3.274.1 ± 4.467.0 ± 3.568.0 ± 4.655.1 ± 2.417.4 ± 3.365.3 ± 3.405.7 ± 3.417.8 ± 2.874.3 ± 2.584.0 ± 3.086.4 ± 4.076.3 ± 2.956.1 ± 2.85
SecondaryGeometric 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
Reported as:
Geometric mean · ratio
Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)
ratioGI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0.9 ± 1.561.0 ± 1.141.0 ± 1.231.0 ± 1.210.9 ± 1.181.0 ± 1.130.9 ± 1.371.1 ± 1.571.0 ± 1.171.0 ± 1.581.0 ± 1.258.7 ± 3.259.7 ± 3.026.7 ± 3.11
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)4.2 ± 3.117.2 ± 2.984.0 ± 2.664.1 ± 2.978.2 ± 2.726.9 ± 3.312.6 ± 2.608.0 ± 3.364.0 ± 3.007.2 ± 3.384.7 ± 1.976.8 ± 2.997.5 ± 2.745.0 ± 2.70
D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)2.1 ± 2.453.0 ± 2.741.9 ± 1.962.6 ± 2.503.2 ± 2.362.7 ± 2.211.7 ± 2.174.1 ± 2.452.0 ± 2.063.1 ± 2.612.2 ± 1.923.9 ± 2.703.5 ± 2.242.5 ± 2.57
D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)1.9 ± 2.772.6 ± 3.201.7 ± 2.412.0 ± 2.332.1 ± 2.341.9 ± 1.991.6 ± 2.462.4 ± 2.401.5 ± 2.271.7 ± 2.411.4 ± 2.272.5 ± 2.602.4 ± 2.221.7 ± 2.64
SecondaryPercentage 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
Reported as:
Number · percentage of participants
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 participantsGI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)0 (0.0 to 11.6)0 (0.0 to 11.6)0 (0.0 to 11.9)0 (0.0 to 11.2)0 (0.0 to 11.6)0 (0.0 to 11.2)3.03 (0.1 to 17.2)0 (0.0 to 10.9)0 (0.0 to 12.3)0 (0.0 to 11.6)0 (0.0 to 12.8)71.4 (51.3 to 86.8)72.4 (52.8 to 87.3)64.5 (45.4 to 80.8)
D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)53.3 (34.3 to 71.7)58.6 (38.9 to 76.5)39.3 (21.5 to 59.4)45.2 (27.3 to 64.0)70.0 (50.6 to 85.3)58.1 (39.1 to 75.5)36.7 (19.9 to 56.1)65.6 (46.8 to 81.4)42.9 (24.5 to 62.8)66.7 (47.2 to 82.7)50.0 (29.9 to 70.1)57.1 (37.2 to 75.5)51.7 (32.5 to 70.6)46.7 (28.3 to 65.7)
D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)30.0 (14.7 to 49.4)NA (NA to NA)NA (NA to NA)25.0 (11.5 to 43.4)NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)
D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)13.3 (3.8 to 30.7)NA (NA to NA)NA (NA to NA)6.5 (0.8 to 21.4)NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA)
percentage of participantsGI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 (0.0 to 11.6)0 (0.0 to 11.9)0 (0.0 to 12.8)6.9 (0.8 to 22.8)0 (0.0 to 11.6)0 (0.0 to 11.2)3.3 (0.1 to 17.2)0 (0.0 to 10.9)0 (0.0 to 12.8)0 (0.0 to 11.6)4.2 (0.1 to 21.1)96.4 (81.7 to 99.9)100.0 (88.1 to 100.0)100.0 (88.4 to 100.0)
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)93.3 (77.9 to 99.2)89.7 (72.6 to 97.8)100.0 (87.7 to 100.0)89.7 (72.6 to 97.8)96.7 (82.8 to 99.9)100.0 (88.8 to 100.0)90.0 (73.5 to 97.9)90.6 (75.0 to 98.0)96.4 (81.7 to 99.9)100.0 (88.4 to 100.0)87.5 (67.6 to 97.3)96.4 (81.7 to 99.9)100.0 (88.1 to 100.0)100.0 (88.4 to 100.0)
D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)80.0 (61.4 to 92.3)NA (NA to NA)NA (NA to NA)71.9 (53.3 to 86.3)NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)
D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)73.3 (54.1 to 87.7)NA (NA to NA)NA (NA to NA)54.8 (36.0 to 72.7)NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA)
percentage of participantsGI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 (0.0 to 11.6)0 (0.0 to 11.9)0 (0.0 to 12.8)0 (0.0 to 11.7)0 (0.0 to 11.9)0 (0.0 to 11.2)3.3 (0.1 to 17.2)3.1 (0.1 to 16.2)0 (0.0 to 12.8)3.3 (0.1 to 17.2)0 (0.0 to 14.2)75.0 (55.1 to 89.3)72.4 (52.8 to 87.3)63.3 (43.9 to 80.1)
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)53.3 (34.3 to 71.7)65.5 (45.7 to 82.1)39.3 (21.5 to 59.4)51.7 (32.5 to 70.6)73.3 (54.1 to 87.7)58.1 (39.1 to 75.5)36.7 (19.9 to 56.1)68.8 (50.0 to 83.9)46.4 (27.5 to 66.1)66.7 (47.2 to 82.7)54.2 (32.8 to 74.4)60.7 (40.6 to 78.5)51.7 (32.5 to 70.6)46.7 (28.3 to 65.7)
D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)36.7 (19.9 to 56.1)NA (NA to NA)NA (NA to NA)34.4 (18.6 to 53.2)NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)
D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)23.3 (9.9 to 42.3)NA (NA to NA)NA (NA to NA)16.1 (5.5 to 33.7)NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)NA (NA to NA)
SecondaryGeometric 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
Reported as:
Geometric mean · titer
Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)
titerGI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)52.9 ± 4.8637.4 ± 3.5942.1 ± 3.6332.1 ± 5.2630.1 ± 3.2644.5 ± 6.0653.6 ± 5.7660.1 ± 6.4536.8 ± 5.3058.5 ± 4.0847.0 ± 4.9173.3 ± 5.2440.8 ± 4.2541.5 ± 3.74
D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)48.9 ± 4.9934.6 ± 3.3841.2 ± 3.8541.0 ± 4.3829.4 ± 3.3146.2 ± 6.2254.4 ± 5.6759.8 ± 6.2337.8 ± 5.2056.3 ± 3.9557.0 ± 5.311649.9 ± 4.882148.2 ± 2.981703.2 ± 2.62
D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,301358.4 ± 4.02996.2 ± 5.022223.3 ± 2.911068.7 ± 5.391368.6 ± 3.991849.8 ± 3.351594.9 ± 4.871435.5 ± 7.022074.3 ± 4.401510.6 ± 4.451131.2 ± 4.28810.7 ± 5.58922.6 ± 3.73848.2 ± 3.63
D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA ± NANA ± NANA ± NANA ± NA302.5 ± 4.10NA ± NANA ± NA512.4 ± 5.85NA ± NANA ± NANA ± NANA ± NANA ± NANA ± NA
D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA ± NANA ± NANA ± NANA ± NA224.0 ± 2.73NA ± NANA ± NA340.1 ± 3.91NA ± NANA ± NANA ± NANA ± NANA ± NANA ± NA
SecondaryGeometric 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
Reported as:
Geometric mean · titer
Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)
titerGI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)83.4 ± 6.63113.6 ± 4.43145.5 ± 4.72119.5 ± 4.4772.8 ± 4.64114.6 ± 4.56100.2 ± 4.47133.0 ± 4.77114.3 ± 4.65158.5 ± 3.41201.7 ± 3.30105.9 ± 4.08121.9 ± 4.16174.5 ± 4.13
D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)77.8 ± 6.49110.0 ± 4.31151.2 ± 4.70125.3 ± 4.3473.8 ± 4.42116.3 ± 4.49106.3 ± 4.05139.2 ± 5.48106.3 ± 4.71164.8 ± 3.16218.8 ± 3.07953.5 ± 2.83948.2 ± 2.521118.0 ± 2.91
D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)495.7 ± 3.30840.8 ± 2.87583.7 ± 2.34467.9 ± 2.79803.3 ± 3.24714.2 ± 2.44336.7 ± 3.741088.9 ± 3.72513.9 ± 3.821117.7 ± 3.031027.3 ± 2.36578.8 ± 3.11552.2 ± 2.60691.2 ± 3.12
D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA ± NANA ± NANA ± NANA ± NA251.8 ± 3.94NA ± NANA ± NA427.9 ± 3.95NA ± NANA ± NANA ± NANA ± NANA ± NANA ± NA
D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA ± NANA ± NANA ± NANA ± NA139.7 ± 4.07NA ± NANA ± NA273.4 ± 3.59NA ± NANA ± NANA ± NANA ± NANA ± NANA ± NA
SecondaryGeometric 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
Reported as:
Geometric mean · ratio
Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)
ratioGI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0.9 ± 1.520.9 ± 1.491.0 ± 1.231.3 ± 2.651.0 ± 1.231.0 ± 1.141.0 ± 1.441.0 ± 1.101.0 ± 1.131.0 ± 1.461.2 ± 1.8622.5 ± 2.9552.7 ± 2.7942.3 ± 2.39
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)25.7 ± 4.4628.0 ± 4.4049.2 ± 2.8134.2 ± 5.5545.4 ± 3.4741.5 ± 3.5029.8 ± 4.6323.9 ± 4.1352.1 ± 3.6125.8 ± 3.1520.8 ± 2.7711.1 ± 2.1922.6 ± 2.2921.1 ± 2.81
D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA ± NANA ± NANA ± NANA ± NA10.0 ± 2.89NA ± NANA ± NA8.5 ± 3.77NA ± NANA ± NANA ± NANA ± NANA ± NANA ± NA
D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA ± NANA ± NANA ± NANA ± NA7.4 ± 2.41NA ± NANA ± NA5.2 ± 3.34NA ± NANA ± NANA ± NANA ± NANA ± NANA ± NA
SecondaryGeometric 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
Reported as:
Geometric mean · ratio
Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)
ratioGI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0.9 ± 1.331.0 ± 1.421.0 ± 1.131.1 ± 1.271.0 ± 1.141.0 ± 1.091.1 ± 1.441.0 ± 1.601.0 ± 1.101.0 ± 1.361.0 ± 1.229.0 ± 2.857.8 ± 2.896.3 ± 3.11
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)5.9 ± 4.377.7 ± 3.923.6 ± 2.454.2 ± 2.5411.0 ± 3.486.2 ± 3.363.4 ± 2.708.2 ± 3.364.0 ± 3.147.1 ± 2.814.9 ± 2.355.5 ± 4.744.5 ± 2.533.9 ± 2.41
D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA ± NANA ± NANA ± NANA ± NA3.5 ± 2.67NA ± NANA ± NA3.2 ± 2.44NA ± NANA ± NANA ± NANA ± NANA ± NANA ± NA
D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0)NA ± NANA ± NANA ± NANA ± NA1.9 ± 2.47NA ± NANA ± NA1.9 ± 2.26NA ± NANA ± NANA ± NANA ± NANA ± NANA ± NA
SecondaryPercentage 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
Reported as:
Number · percentage of participants
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 participantsGI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)0 (0.0 to 11.6)0 (0.0 to 11.6)0 (0.0 to 11.9)0 (0.0 to 11.2)0 (0.0 to 11.6)0 (0.0 to 11.2)0 (0.0 to 11.6)0 (0.0 to 10.9)0 (0.0 to 12.3)0 (0.0 to 11.6)0 (0.0 to 12.8)67.9 (47.6 to 84.1)62.1 (42.3 to 79.3)67.7 (48.6 to 83.3)
D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)33.3 (17.3 to 52.8)55.2 (35.7 to 73.6)32.1 (15.9 to 52.4)35.5 (19.2 to 54.6)66.7 (47.2 to 82.7)51.6 (33.1 to 69.8)26.7 (12.3 to 45.9)59.4 (40.6 to 76.3)28.6 (13.2 to 48.7)60.0 (40.6 to 77.3)53.8 (33.4 to 73.4)75.0 (55.1 to 89.3)58.6 (38.9 to 76.5)56.7 (37.4 to 74.5)
D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,28)10.0 (2.1 to 26.5)20.7 (8.0 to 39.7)16.7 (5.6 to 34.7)6.5 (0.8 to 21.4)13.3 (3.8 to 30.7)13.3 (3.8 to 30.7)20.0 (7.7 to 38.6)31.3 (16.1 to 50.0)20.7 (8.0 to 39.7)16.7 (5.6 to 34.7)7.4 (0.9 to 24.3)42.9 (24.5 to 62.8)34.5 (17.9 to 54.3)21.4 (8.3 to 41.0)
D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,28)3.4 (0.1 to 17.8)13.8 (3.9 to 31.7)6.7 (0.8 to 22.1)3.2 (0.1 to 16.7)6.7 (0.8 to 22.1)3.4 (0.1 to 17.8)6.9 (0.8 to 22.8)9.4 (2.0 to 25.0)3.4 (0.1 to 17.8)3.3 (0.1 to 17.2)3.7 (0.1 to 19.0)7.1 (0.9 to 23.5)10.3 (2.2 to 27.4)7.1 (0.9 to 23.5)
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA)
percentage of participantsGI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0 (0.0 to 11.6)0 (0.0 to 11.9)0 (0.0 to 12.8)0 (0.0 to 11.9)0 (0.0 to 11.6)0 (0.0 to 11.2)0 (0.0 to 11.6)0 (0.0 to 10.9)0 (0.0 to 12.8)0 (0.0 to 11.6)0 (0.0 to 14.2)82.1 (63.1 to 93.9)96.6 (82.2 to 99.9)93.3 (77.9 to 99.2)
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)80.0 (61.4 to 92.3)79.3 (60.3 to 92.0)85.7 (67.3 to 96.0)82.8 (64.2 to 94.2)86.7 (69.3 to 96.2)87.1 (70.2 to 96.4)76.7 (57.7 to 90.1)78.1 (60.0 to 90.7)85.7 (67.3 to 96.0)90.0 (73.5 to 97.9)70.8 (48.9 to 87.4)100.0 (87.7 to 100.0)96.6 (82.2 to 99.9)93.3 (77.9 to 99.2)
D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)53.3 (34.3 to 71.7)65.5 (45.7 to 82.1)67.9 (47.6 to 84.1)58.6 (38.9 to 76.5)43.3 (25.5 to 62.6)70.0 (50.6 to 85.3)60.0 (40.6 to 77.3)78.1 (60.0 to 90.7)82.1 (63.1 to 93.9)56.7 (37.4 to 74.5)33.3 (15.6 to 55.3)85.7 (67.3 to 96.0)93.1 (77.2 to 99.2)77.8 (57.7 to 91.4)
D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)31.0 (15.3 to 50.8)32.1 (15.9 to 52.4)50.0 (30.6 to 69.4)37.9 (20.7 to 57.7)23.3 (9.9 to 42.3)37.9 (20.7 to 57.7)44.8 (26.4 to 64.3)53.1 (34.7 to 70.9)53.6 (33.9 to 72.5)26.7 (12.3 to 45.9)29.2 (12.6 to 51.1)50.0 (30.6 to 69.4)51.7 (32.5 to 70.6)46.4 (27.5 to 66.1)
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA)
percentage of participantsGI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)3.3 (0.1 to 17.2)0 (0.0 to 11.9)3.7 (0.1 to 19.0)0 (0.0 to 11.9)3.3 (0.1 to 17.2)0 (0.0 to 11.2)0 (0.0 to 11.6)3.1 (0.1 to 16.2)3.7 (0.1 to 19.0)3.3 (0.1 to 17.2)0 (0.0 to 14.2)82.1 (63.1 to 93.9)65.5 (45.7 to 82.1)70.0 (50.6 to 85.3)
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)46.7 (28.3 to 65.7)72.4 (52.8 to 87.3)39.3 (21.5 to 59.4)41.4 (23.5 to 61.1)80.0 (61.4 to 92.3)61.3 (42.2 to 78.2)26.7 (12.3 to 45.9)71.9 (53.3 to 86.3)35.7 (18.6 to 55.9)63.3 (43.9 to 80.1)66.7 (44.7 to 84.4)75.0 (55.1 to 89.3)58.6 (38.9 to 76.5)60.0 (40.6 to 77.3)
D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)26.7 (12.3 to 45.9)31.0 (15.3 to 50.8)17.9 (6.1 to 36.9)20.7 (8.0 to 39.7)43.3 (25.5 to 62.6)20.0 (7.7 to 38.6)20.0 (7.7 to 38.6)43.8 (26.4 to 62.3)21.4 (8.3 to 41.0)33.3 (17.3 to 52.8)25.0 (9.8 to 46.7)50.0 (30.6 to 69.4)37.9 (20.7 to 57.7)22.2 (8.6 to 42.3)
D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)13.8 (3.9 to 31.7)21.4 (8.3 to 41.0)3.6 (0.1 to 18.3)17.2 (5.8 to 35.8)23.3 (9.9 to 42.3)3.4 (0.1 to 17.8)10.3 (2.2 to 27.4)12.5 (3.5 to 29.0)10.7 (2.3 to 28.2)16.7 (5.6 to 34.7)4.2 (0.1 to 21.1)21.4 (8.3 to 41.0)24.1 (10.3 to 43.5)10.7 (2.3 to 28.2)
SecondaryBlocking 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
Reported as:
Geometric mean · titer
Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)
titerGI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)24.8 ± 2.7518.7 ± 1.8526.0 ± 2.7326.8 ± 3.3519.1 ± 1.6824.8 ± 2.3130.5 ± 3.0424.5 ± 2.5923.8 ± 2.4623.2 ± 2.1926.3 ± 2.6823.1 ± 2.2522.3 ± 2.2620.6 ± 2.04
D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)25.0 ± 2.6018.6 ± 1.8623.8 ± 2.4426.7 ± 3.1918.6 ± 1.7023.0 ± 2.2427.3 ± 2.4625.1 ± 2.5225.5 ± 2.5224.8 ± 2.3728.5 ± 2.66347.6 ± 4.62385.9 ± 3.64391.1 ± 3.56
D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)280.5 ± 3.94236.3 ± 4.61403.3 ± 3.74286.9 ± 5.0122.86 ± 3.94356.4 ± 3.74400.1 ± 3.33412.9 ± 4.78510.0 ± 4.36247.2 ± 3.43271.3 ± 5.00398.6 ± 2.70463.5 ± 2.32355.8 ± 2.58
D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)130.0 ± 3.3898.2 ± 3.46159.0 ± 3.23136.4 ± 3.6780.1 ± 3.49139.3 ± 2.68159.8 ± 2.73202.1 ± 3.34208.6 ± 3.28114.5 ± 2.89107.9 ± 3.28196.4 ± 2.86219.2 ± 2.29182.0 ± 2.40
D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29)67.8 ± 3.7851.3 ± 3.2388.1 ± 3.5474.8 ± 4.2644.0 ± 3.3971.9 ± 3.4091.5 ± 3.14107.5 ± 3.9799.6 ± 4.0955.0 ± 3.2266.1 ± 3.86103.4 ± 3.95113.6 ± 3.3081.0 ± 2.85
SecondaryBlocking 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
Reported as:
Geometric mean · titer
Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)
titerGI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
D1 (n=30,30,30,31,30,31,30,32,29,30,29,28,29,31)66.0 ± 4.8580.1 ± 3.44115.3 ± 4.2491.4 ± 4.1560.9 ± 3.8496.6 ± 4.0380.7 ± 4.4889.8 ± 4.4196.2 ± 3.93102.3 ± 3.39121.9 ± 3.4756.1 ± 3.4892.0 ± 3.96117.8 ± 3.91
D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31)69.3 ± 4.5675.7 ± 3.63124.9 ± 3.9887.9 ± 3.7567.7 ± 3.7694.5 ± 4.3074.6 ± 4.1798.1 ± 5.1192.9 ± 3.87123.3 ± 3.25117.6 ± 3.62552.6 ± 3.65688.4 ± 3.16904.4 ± 2.67
D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30)336.9 ± 3.40686.3 ± 3.47429.0 ± 2.40317.8 ± 2.94675.7 ± 3.21632.1 ± 2.11189.2 ± 4.63842.8 ± 3.23360.1 ± 3.85862.8 ± 3.12778.0 ± 2.57426.5 ± 3.46596.3 ± 2.86604.4 ± 2.91
D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29)186.7 ± 3.19241.5 ± 3.24244.6 ± 2.78206.3 ± 2.84229.9 ± 3.60259.7 ± 2.66142.5 ± 4.09346.8 ± 2.92201.0 ± 3.49340.6 ± 2.60324.6 ± 3.07277.5 ± 2.53350.9 ± 2.36295.3 ± 3.07
D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,28)120.5 ± 4.21180.2 ± 3.95123.5 ± 3.87133.2 ± 3.81104.7 ± 4.01134.4 ± 3.74109.3 ± 4.44182.9 ± 3.60121.9 ± 3.88179.7 ± 2.53209.0 ± 3.38126.2 ± 3.56171.2 ± 3.61192.9 ± 3.52
SecondaryGeometric 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
Reported as:
Geometric mean · titer
Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)
titerGI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 ± 1.301.0 ± 1.080.9 ± 1.301.0 ± 1.211.0 ± 1.370.9 ± 1.260.9 ± 1.591.0 ± 1.221.1 ± 1.371.1 ± 1.281.0 ± 1.3115.0 ± 3.8017.3 ± 3.0219.3 ± 3.33
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)11.3 ± 4.2513.2 ± 4.3114.9 ± 3.5410.0 ± 4.0712.0 ± 3.3614.3 ± 2.9813.1 ± 3.9616.9 ± 4.6021.1 ± 3.7210.7 ± 2.539.7 ± 4.2917.2 ± 2.3620.8 ± 2.2017.9 ± 2.68
D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)5.2 ± 3.415.5 ± 3.186.0 ± 2.974.8 ± 2.914.2 ± 2.945.9 ± 2.005.2 ± 2.698.2 ± 3.148.6 ± 2.634.9 ± 2.243.7 ± 2.958.5 ± 2.529.8 ± 2.187.9 ± 2.21
D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)2.7 ± 3.292.7 ± 2.713.3 ± 2.872.6 ± 2.972.3 ± 2.653.0 ± 2.352.9 ± 2.614.4 ± 3.304.0 ± 3.102.4 ± 2.352.4 ± 2.734.5 ± 3.295.1 ± 2.813.8 ± 2.60
SecondaryGeometric 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
Reported as:
Geometric mean · titer
Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)
titerGI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.1 ± 1.680.9 ± 1.591.0 ± 1.471.0 ± 1.731.1 ± 1.621.0 ± 1.380.9 ± 1.291.1 ± 1.891.0 ± 1.591.2 ± 2.451.0 ± 1.469.8 ± 3.487.5 ± 3.137.0 ± 2.96
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)5.1 ± 4.428.9 ± 3.313.6 ± 2.713.7 ± 3.4311.1 ± 3.326.5 ± 3.332.3 ± 2.959.4 ± 3.953.5 ± 3.618.4 ± 3.596.0 ± 2.247.6 ± 3.196.5 ± 2.944.8 ± 2.46
D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27)2.8 ± 3.103.1 ± 2.512.0 ± 2.422.4 ± 2.583.8 ± 2.562.5 ± 1.991.8 ± 2.273.9 ± 3.032.0 ± 2.303.3 ± 2.662.5 ± 1.734.9 ± 2.723.8 ± 2.812.5 ± 2.35
D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28)1.7 ± 3.142.3 ± 2.421.0 ± 2.431.5 ± 2.561.7 ± 2.321.4 ± 1.821.3 ± 2.252.0 ± 2.591.3 ± 2.281.8 ± 2.111.6 ± 1.902.2 ± 2.701.9 ± 2.621.4 ± 2.23
SecondaryGMFR 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
Reported as:
Geometric mean · titer
GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)
titerGI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)1.0 ± 1.171.0 ± 1.180.9 ± 1.121.0 ± 1.221.0 ± 1.110.9 ± 1.220.9 ± 1.181.0 ± 1.670.9 ± 1.981.0 ± 1.121.0 ± 1.137.4 ± 2.974.5 ± 2.945.7 ± 3.01
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)3.4 ± 2.915.1 ± 2.781.7 ± 1.812.6 ± 2.784.2 ± 3.203.7 ± 3.171.6 ± 2.065.9 ± 4.172.7 ± 3.164.6 ± 2.733.1 ± 2.364.6 ± 2.943.6 ± 2.624.0 ± 2.45
D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA ± NANA ± NANA ± NANA ± NA1.8 ± 2.34NA ± NANA ± NA2.4 ± 2.89NA ± NANA ± NANA ± NANA ± NANA ± NANA ± NA
D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA ± NANA ± NANA ± NANA ± NA1.4 ± 2.08NA ± NANA ± NA1.9 ± 2.56NA ± NANA ± NANA ± NANA ± NANA ± NANA ± NA
SecondaryGMFR 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
Reported as:
Geometric mean · titer
GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)
titerGI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)0.9 ± 1.221.0 ± 1.260.9 ± 1.121.0 ± 1.180.9 ± 1.221.0 ± 1.090.9 ± 1.471.1 ± 1.911.0 ± 1.051.0 ± 1.251.0 ± 1.062.2 ± 2.482.5 ± 2.802.8 ± 2.77
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)1.5 ± 2.592.3 ± 2.101.3 ± 1.671.3 ± 1.482.0 ± 2.461.7 ± 1.821.1 ± 1.602.9 ± 3.501.6 ± 1.772.5 ± 2.622.0 ± 2.021.8 ± 2.251.9 ± 2.302.1 ± 2.25
D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA ± NANA ± NANA ± NANA ± NA1.4 ± 1.93NA ± NANA ± NA1.6 ± 2.10NA ± NANA ± NANA ± NANA ± NANA ± NANA ± NA
D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA ± NANA ± NANA ± NANA ± NA1.0 ± 1.78NA ± NANA ± NA1.4 ± 2.28NA ± NANA ± NANA ± NANA ± NANA ± NANA ± NA
SecondaryGMFR 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
Reported as:
Geometric mean · titer
GMFR of Antibody Titers of Strains Not Represented in the Investigational Vaccine: Cross-Protection Assays
titerGI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (15/50)
GII.2 EC501.1 ± 1.920.8 ± 3.73
GI.3 EC505.9 ± 3.233.0 ± 3.36
GII.4.2012 EC503.2 ± 2.504.1 ± 3.51
SecondaryBlocking 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
Reported as:
Geometric mean · titer
Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)
titerGI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
D1 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)63.7 ± 4.3475.1 ± 3.85114.7 ± 4.2885.8 ± 4.1963.0 ± 4.0889.1 ± 4.1399.8 ± 4.4785.0 ± 4.6491.8 ± 4.02112.6 ± 3.26134.8 ± 3.0754.0 ± 3.9581.8 ± 3.8693.2 ± 3.75
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)63.6 ± 4.3172.9 ± 3.95113.8 ± 4.0283.3 ± 4.0561.7 ± 4.0484.4 ± 4.2390.5 ± 4.1688.0 ± 5.4978.6 ± 4.06109.0 ± 3.25130.6 ± 2.95400.0 ± 3.57366.9 ± 4.60534.2 ± 3.17
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)217.3 ± 3.57380.7 ± 3.61200.3 ± 4.33221.0 ± 3.66263.7 ± 5.77327.5 ± 4.12161.5 ± 4.66501.4 ± 5.07248.5 ± 4.56518.8 ± 3.40415.5 ± 4.11248.3 ± 4.01296.5 ± 4.12373.4 ± 3.40
D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA ± NANA ± NANA ± NANA ± NA113.5 ± 5.03NA ± NANA ± NA202.5 ± 4.06NA ± NANA ± NANA ± NANA ± NANA ± NANA ± NA
D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA ± NANA ± NANA ± NANA ± NA88.9 ± 3.90NA ± NANA ± NA160.8 ± 3.96NA ± NANA ± NANA ± NANA ± NANA ± NANA ± NA
SecondaryBlocking 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
Reported as:
Geometric mean · titer
Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)
titerGI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
D1 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)35.0 ± 3.8626.0 ± 2.3043.3 ± 3.2932.4 ± 3.2428.3 ± 2.4537.5 ± 3.1829.7 ± 3.3428.0 ± 2.9332.2 ± 3.0928.1 ± 2.3132.3 ± 2.7921.6 ± 2.1129.7 ± 2.4837.3 ± 3.42
D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30)32.6 ± 3.4924.8 ± 2.2942.5 ± 3.1031.1 ± 3.1226.4 ± 2.4436.3 ± 3.0925.9 ± 3.0830.2 ± 3.8732.9 ± 3.0927.8 ± 2.2831.8 ± 2.7348.0 ± 3.3775.1 ± 3.35104.8 ± 3.35
D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30)53.5 ± 3.9359.3 ± 2.7956.7 ± 3.0640.6 ± 3.3755.5 ± 3.3362.1 ± 3.2631.2 ± 3.0480.6 ± 4.3751.2 ± 3.3170.4 ± 3.2264.4 ± 3.5238.8 ± 2.9856.7 ± 3.1579.1 ± 3.18
D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA ± NANA ± NANA ± NANA ± NA40.2 ± 3.14NA ± NANA ± NA44.2 ± 3.17NA ± NANA ± NANA ± NANA ± NANA ± NANA ± NA
D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0)NA ± NANA ± NANA ± NANA ± NA28.5 ± 2.37NA ± NANA ± NA38.3 ± 2.87NA ± NANA ± NANA ± NANA ± NANA ± NANA ± NA
SecondaryBlocking 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
Reported as:
Geometric mean · titer
Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GII.2 EC50 (HBGA)
titerGI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (15/50)
Day 1266.2 ± 2.62265.5 ± 4.79
Day 56295.8 ± 2.31216.5 ± 4.46
SecondaryBlocking 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
Reported as:
Geometric mean · titer
Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GI.3 EC50 (HBGA)
titerGI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (15/50)
Day 159.7 ± 2.9874.1 ± 3.70
Day 56350.5 ± 3.05222.7 ± 5.09
SecondaryBlocking 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
Reported as:
Geometric mean · titer
Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GII.4.2012 EC50 (HBGA)
titerGI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (15/50)
Day 145.5 ± 4.0750.7 ± 5.10
Day 56146.6 ± 3.11208.5 ± 3.80
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With Significant New Medical Conditions
percentage of participantsGI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
AESIs6.73.306.5006.76.30007.13.40
IMEs00000000000000
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Participants With Any Adverse Event (AE) Leading to Withdrawal From the Study
percentage of participantsGI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Percentage of Participants With Any Adverse Event (AE) Leading to Withdrawal From the Study00000000000000

Adverse events

Collected over Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393). Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
GI.1/GII.4 (15/15) - MPL (50)—2/30 (6.7%)10/30 (33.3%)
GI.1/GII.4 (15/50) - MPL (50)—0/30 (0%)12/30 (40%)
GI.1/GII.4 (50/50) - MPL (50)—5/30 (16.7%)7/30 (23.3%)
GI.1/GII.4 (15/15) - MPL (15)—2/31 (6.5%)10/31 (32.3%)
GI.1/GII.4 (15/50) - MPL (15)—1/30 (3.3%)9/30 (30%)
GI.1/GII.4 (50/50) - MPL (15)—0/31 (0%)9/31 (29%)
GI.1/GII.4 (15/15)—3/30 (10%)7/30 (23.3%)
GI.1/GII.4 (15/50)—3/32 (9.4%)11/32 (34.4%)
GI.1/GII.4 (50/50)—1/29 (3.4%)8/29 (27.6%)
GI.1/GII.4 (50/150)—1/30 (3.3%)6/30 (20%)
GI.1/GII.4 (15/50) - Al(OH)3 (167)—1/29 (3.4%)6/29 (20.7%)
GI.1/GII.4 (15/50) x2—2/28 (7.1%)9/28 (32.1%)
GI.1/GII.4 (50/150) x2—1/29 (3.4%)8/29 (27.6%)
GI.1/GII.4 (15/50) - Al(OH)3 (167) x2—1/31 (3.2%)9/31 (29%)
Most frequent serious events
Showing 10 of 25
Most frequent serious events
EventGI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
Rectal adenocarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/300/300/300/310/300/310/300/320/290/300/291/280/290/31
Major depressionPsychiatric disorders0/300/300/300/310/300/310/300/320/290/300/291/280/290/31
OsteoarthritisMusculoskeletal and connective tissue disorders0/300/301/300/311/300/310/300/320/290/301/290/280/290/31
AppendicitisInfections and infestations0/300/300/300/310/300/310/300/320/290/300/290/281/290/31
Large intestinal polypGastrointestinal disorders0/300/300/300/310/300/310/300/321/290/300/290/280/290/31
ChondropathyMusculoskeletal and connective tissue disorders0/300/300/300/310/300/311/300/320/290/300/290/280/290/31
Gastroenteritis bacterialInfections and infestations0/300/300/300/310/300/310/300/320/291/300/290/280/290/31
LeptospirosisInfections and infestations1/300/300/300/310/300/310/300/320/290/300/290/280/290/31
Meningitis asepticInfections and infestations1/300/300/300/310/300/310/300/320/290/300/290/280/290/31
PneumoniaInfections and infestations0/300/300/300/310/300/311/300/320/290/300/290/280/290/31
Most frequent other events
Most frequent other events
EventGI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2
HeadacheNervous system disorders3/308/303/303/313/303/310/300/321/291/304/292/282/292/31
DiarrhoeaGastrointestinal disorders1/303/300/302/312/301/314/302/321/290/300/293/281/291/31
Oropharyngeal PainRespiratory, thoracic and mediastinal disorders1/303/301/302/313/301/311/303/320/291/303/291/282/291/31
NasopharyngitisInfections and infestations3/303/303/300/310/300/311/302/321/291/301/291/281/292/31
Influenza like illnessGeneral disorders0/300/301/301/310/303/310/301/320/291/300/290/281/291/31
NauseaGastrointestinal disorders2/302/300/300/312/300/310/302/322/292/301/292/282/291/31
Injection site painGeneral disorders0/302/301/300/310/302/311/300/322/290/300/291/281/290/31
Abdominal painGastrointestinal disorders0/301/301/302/312/301/310/300/321/290/300/290/280/292/31
FatigueGeneral disorders2/302/302/301/312/300/310/301/320/290/300/291/280/290/31

Baseline characteristics

All randomized participants.

Age, Continuous
Age, Continuous(years)GI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Total
Median50.0 ± 14.7051.0 ± 14.3650.0 ± 12.9550.0 ± 14.9549.5 ± 13.7950.0 ± 14.3949.5 ± 14.1948.5 ± 14.1341.0 ± 14.8251.0 ± 15.2649.0 ± 15.4148.5 ± 14.0548.0 ± 15.0644.0 ± 16.1149.5 (18 to 64)
Age, Customized
Age, Customized(participants)GI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Total
18-49 Years1514151515151516151515141516210
50-64 Years1516151615161516141514141415210
Sex: Female, Male
Sex: Female, Male(Participants)GI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Total
Female1820202219231518202316162018268
Male12101091181514971312913152
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)GI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Total
American Indian or Alaska Native000001000000001
Asian100101001100005
White2930303030293032282929282931414
Region of Enrollment
Region of Enrollment(participants)GI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Total
Belgium3030303130313032293029282931420
Height
Height(cm)GI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Total
Median173.0 (156 to 187)167.0 (154 to 193)166.5 (153 to 191)167.0 (149 to 187)171.0 (155 to 186)169.0 (153 to 190)173.5 (154 to 189)169.5 (161 to 192)171.0 (153 to 193)167.0 (153 to 186)172.0 (156 to 199)171.5 (161 to 192)170.0 (153 to 187)175.0 (146 to 192)170.0 (146 to 199)
Weight
Weight(kg)GI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Total
Median69.50 (49.4 to 105.2)65.60 (49.1 to 103.0)70.60 (50.8 to 104.0)66.60 (42.2 to 103.3)71.60 (47.6 to 101.9)68.50 (44.0 to 96.0)72.50 (45.8 to 104.5)74.35 (52.0 to 110.3)76.00 (54.8 to 101.2)69.85 (50.5 to 92.6)70.00 (49.6 to 94.0)75.50 (42.5 to 92.5)70.60 (49.2 to 111.8)69.90 (51.0 to 111.3)70.8 (42.2 to 111.8)
Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m^2)GI.1/GII.4 (15/15) - MPL (50)GI.1/GII.4 (15/50) - MPL (50)GI.1/GII.4 (50/50) - MPL (50)GI.1/GII.4 (15/15) - MPL (15)GI.1/GII.4 (15/50) - MPL (15)GI.1/GII.4 (50/50) - MPL (15)GI.1/GII.4 (15/15)GI.1/GII.4 (15/50)GI.1/GII.4 (50/50)GI.1/GII.4 (50/150)GI.1/GII.4 (15/50) - Al(OH)3 (167)GI.1/GII.4 (15/50) x2GI.1/GII.4 (50/150) x2GI.1/GII.4 (15/50) - Al(OH)3 (167) x2Total
Median25.22 (16.7 to 33.6)23.97 (18.9 to 34.2)26.11 (17.3 to 33.4)23.62 (18.7 to 33.7)24.51 (18.6 to 34.2)24.73 (17.6 to 34.4)24.40 (18.1 to 33.7)24.06 (17.8 to 33.2)26.06 (19.0 to 34.6)25.02 (20.0 to 34.4)23.66 (18.1 to 32.3)24.24 (14.9 to 32.7)23.19 (18.7 to 33.8)24.54 (17.9 to 33.5)24.52 (14.9 to 34.6)
08

Study locations

2 sites
  • Universiteit Antwerpen
    Edegem, 2650, Belgium
  • Universitair Ziekenhuis Gent
    Gent, 9000, Belgium
09

References and documents

Publications

  • Leroux-Roels G, Cramer JP, Mendelman PM, Sherwood J, Clemens R, Aerssens A, De Coster I, Borkowski A, Baehner F, Van Damme P. Safety and Immunogenicity of Different Formulations of Norovirus Vaccine Candidate in Healthy Adults: A Randomized, Controlled, Double-Blind Clinical Trial. J Infect Dis. 2018 Jan 30;217(4):597-607. doi: 10.1093/infdis/jix572. PubMed 29140444 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02038907
Lead sponsor
Takeda
Responsible party
Sponsor
First posted
Jan 17, 2014
Start date
Mar 28, 2014
Primary completion
Jun 19, 2015
Completion
Jun 19, 2015
Results posted
Aug 1, 2016
Last update
Aug 8, 2017

Study contacts

Medical Director Clinical Science
study director · Takeda

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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