Gastroenteritis
Conditions
Keywords
Vaccine, norovirus, acute gastroenteritis
Brief summary
Randomized, multi-site, dose-escalation study of the safety and immunogenicity of four dosage levels of Intramuscular (IM) Norovirus Bivalent VLP Vaccine adjuvanted with MPL and Al(OH)3 compared to controls. Participants will receive two doses, by IM injection, 28 days apart. The hypotheses for this study are: * The incidence of adverse events after vaccination with IM Norovirus Bivalent VLP Vaccine will be similar to the incidence of adverse events after other IM vaccines including CERVARIX® which contains MPL and Al(OH)3. * Two doses of IM Norovirus Bivalent VLP Vaccine will be more immunogenic than one dose. * The post-vaccination serum antibody responses, the number of antibody secreting cells (ASC), including homing markers, and memory B-cell responses directed against norovirus antigens will be increased after IM Norovirus Bivalent VLP Vaccine compared to controls.
Interventions
BIOLOGICALNoV GI.1/GII.4 Bivalent VLP Vaccine
2 Doses 28 days apart Cohort A: 18-49 Years Cohort A1: IM Norovirus Bivalent GI.1/GII.4 VLP Vaccine (5/5 mcg) Cohort A2: IM Norovirus Bivalent GI.1/GII.4 VLP Vaccine (15/15 mcg) Cohort A3: IM Norovirus Bivalent GI.1/GII.4 VLP Vaccine (50/50 mcg) Cohort A4: IM Norovirus Bivalent GI.1/GII.4 VLP Vaccine (150/150 mcg) Cohort B: 50-64 Years IM Norovirus Bivalent GI.1/GII.4 VLP Vaccine (50/50 mcg) Cohort C: 65-85 Years IM Norovirus Bivalent GI.1/GII.4 VLP Vaccine (50/50 mcg) Cohort D: 18-49 Years IM Norovirus Bivalent GI.1/GII.4 VLP Vaccine (50/50 mcg)
BIOLOGICALSaline
Two doses 28 days apart
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
Participants must meet all of the inclusion criteria listed below: 1. Signed written informed consent. 2. Age: * Cohort A: 18-49 years, inclusive * Cohort B: 50-64 years, inclusive * Cohort C: 65-85 years, inclusive * Cohort D: 18-49 years, inclusive 3. Health Status: * Cohort A and D: In good health as determined by a screening evaluation that includes vital signs, medical history, and physical exam within 45 days before administration of IM Norovirus Bivalent VLP Vaccine or control. * Cohorts B and C: In good health as determined by a screening evaluation that includes vital signs, medical history, and physical exam within 45 days before administration of IM Norovirus Bivalent VLP Vaccine or control. Any existing medical diagnoses or conditions must be stable based on medical history and targeted physical examination. A stable medical condition is defined as: (A) Clinically acceptable health outcomes for the specific condition over the prior 6 months and (B) No change in prescription medication(s), dose, or frequency over the prior 3 months. Acceptable changes in medications are: a change of health care provider or insurance company or that is made for financial reasons as long as the medications are in the same class and/or a change due to improvement in a disease outcome. 4. Expressed interest and availability to fulfill the study requirements. 5. Female participants must be of non-childbearing potential (surgically sterile or post-menopausal for greater than or equal to \[\>=\] 12 months), or if of childbearing potential (as determined by the investigator) must be practicing abstinence or using an effective licensed method of birth control (example oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream, or foam; intrauterine contraceptive device, or Depo-Provera; skin patch; vaginal ring or cervical cap) for 30 days prior to vaccination and must agree to continue such precautions for at least 60 days after the last vaccination. A woman is eligible if she is monogamous with a male who has had a vasectomy. Male participants must agree not to father a child for at least 60 days after the last vaccination and to practice abstinence or use an effective method of birth control as noted above. 6. Agrees not to participate in another clinical trial with an investigational product for the entire duration of the study one year after the last study dose that is 393 days. 7. Agrees to storage of unused clinical specimens for an indefinite period of time for future norovirus research or research on other gastrointestinal pathogens.
Exclusion criteria
Participants who meet any of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Day 0 up to Day 7 | The solicited local adverse events were reported using a memory aid. Pain was scaled as Mild (did not interfere with activity); Moderate (repeated use of non-narcotic pain reliever greater than (\>) 24 hours \[24h\] or interfered with activity); and Severe (any use of narcotic pain reliever or prevented daily activity). Tenderness was scaled as Mild (mild discomfort to touch); Moderate (discomfort with movement); and Severe (significant discomfort at rest). Swelling and redness were scaled as Mild (2.5-5 centimeter \[cm\] and did not interfere with activity); Moderate (5.1-10 cm or interfered with activity); and Severe (\>10 cm or prevented daily activity). |
| Number of Participants With Solicited Local AEs Post Dose 2 | Day 28 up to Day 35 | The solicited local adverse events were reported using a memory aid. Pain was scaled as Mild (did not interfered with activity); Moderate (repeated use of non-narcotic pain reliever \>24h or interfered with activity); and Severe (any use of narcotic pain reliever or prevented daily activity). Tenderness was scaled as Mild (mild discomfort to touch); Moderate (discomfort with movement); and Severe (significant discomfort at rest). Swelling and redness were scaled as Mild (2.5-5 cm and did not interfere with activity); Moderate (5.1-10 cm or interfered with activity); and Severe (\>10 cm or prevented daily activity). |
| Number of Participants With Solicited Systemic AEs Post Dose 1 | Day 0 up to Day 7 | Elevated oral temperature:Mild(38-38.4 Celsius\[C\]);Moderate(38.5-38.9 C);Severe(39-40 C).Headache:Mild(no interference with activity);Moderate(repeated use of non-narcotic pain reliever\>24h/some interference with activity);Severe(significant;any use of narcotic pain reliever/prevented daily activity).Fatigue,Malaise:Mild(no interference with activity);Moderate(some interference with activity);Severe(significant;prevented daily activity).Diarrhea:Mild(2-3loose stools/\<400gram\[g\]/24h);Moderate(4-5stools/400-800g/24h);Severe(\>=6watery stools/\>800g/24h/required intravenous\[IV\]hydration).Nausea/Vomiting:Mild(no interference with activity/1-2 episodes/24h);Moderate(some interference with activity/\>2 episodes/24h);Severe(prevented daily activity,required IV hydration).Muscle ache,chills,joint ache,abdominal cramp/pain:Mild(no interference with activity);Moderate(some interference with activity,not required medical intervention);Severe(prevented daily activity,required medical intervention). |
| Number of Participants With Solicited Systemic AEs Post Dose 2 | Day 28 up to Day 35 | Elevated oral temperature:Mild(38-38.4 C);Moderate(38.5-38.9 C);Severe(39-40 C).Headache:Mild(no interference with activity);Moderate(repeated use of non-narcotic pain reliever\>24h/some interference with activity);Severe(significant;any use of narcotic pain reliever/prevented daily activity).Fatigue,Malaise:Mild(no interference with activity);Moderate(some interference with activity);Severe(significant;prevented daily activity).Diarrhea:Mild(2-3loose stools/\<400g/24h);Moderate(4-5stools/400-800g/24h);Severe(\>=6watery stools/\>800g/24h/required IV hydration).Nausea/Vomiting:Mild(no interference with activity/1-2 episodes/24h);Moderate(some interference with activity/\>2 episodes/24h);Severe(prevented daily activity,required IV hydration).Muscle ache,chills,joint ache,abdominal cramp/pain:Mild(no interference with activity);Moderate(some interference with activity,not required medical intervention);Severe(prevented daily activity,required medical intervention). |
| Number of Participants With Unsolicited AEs Post Dose 1 | Baseline up to Day 28 (Pre-dose 2) | — |
| Number of Participants With Unsolicited AEs Post Dose 2 | Day 28 up to Day 56 (Post dose 2) | — |
| Number of Participants With Clinically Significant Change From Baseline in Markedly Abnormal Laboratory Values | Baseline up to Day 35 | The number of participants with any markedly abnormal standard safety laboratory values (serum chemistry or hematology) collected throughout study. |
| Number of Participants With Serious Adverse Events (SAEs), Onset of Significant New Medical Conditions, Including Adverse Events of Special Interest (AESI) | Baseline up to 365 Days after post dose 2 (Day 393) | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgM | I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393) | Seroresponse was defined as a 4-fold increase in antibody titer compared to pre-immunization titers. Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved. |
| GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | I run: predose 1, 7, 21, 28 days PD1, 7 and 28 days PD2; II run: predose 1, 28, 152 and 365 days PD2 (up to Day 393) | GMTs were assessed for Anti-norovirus GI.1 and GII.4 VLP by Pan-Ig ELISA. A pan ELISA assay captured IgG, IgA and IgM combined. Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved. |
| Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | First (I) run: predose 1 and 7, 21, 28 days postdose (PD)1, and 7 and 28 days PD2; second (II) run: predose 1 and 28, 152 and 365 days PD2 (up to Day 393) | Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved. |
| Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393) | Seroresponse was defined as a 4-fold increase in antibody titer compared to pre-immunization titers. Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved. |
| GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393) | GMFRs in GMTs of Anti-norovirus GI.1 and GII.4 VLP by Pan-Ig ELISA. A pan ELISA assay captured IgG, IgA and IgM combined. Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved. |
| GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | I run: predose 1 and 7, 21, 28 days PD1, and 7 and 28 days PD2; II run: predose 1 and 28, 152 and 365 days PD2 (up to Day 393) | Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved. |
| GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgM | I run: predose 1 and 7, 21, 28 days PD1, and 7 and 28 days PD2; II run: predose 1 and 28, 152 and 365 days PD2 (up to Day 393) | Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved. |
| Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393) | Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved. |
| GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393) | Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved. |
| GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgM as Compared to Baseline | I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393) | Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved. |
| Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393) | Seroresponse was defined as a 4-fold increase in antibody titer compared to pre-immunization titers. Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved. |
| Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393) | Seroresponse was defined as a 4-fold increase in antibody titer compared to pre-immunization titers. Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved. |
Countries
United States
Participant flow
Recruitment details
Participants took part in the study at 3 investigative sites in the United States from 03 September 2010 to 09 January 2013.
Pre-assignment details
Healthy volunteers were enrolled in 1 of the following treatment groups: Bivalent Norovirus GI.1/GII.4 Vaccine (Cohort A: 5/5 microgram \[mcg\], 15/15 mcg, 50/50 mcg, 150/150 mcg; Cohort B: 50/50 mcg; Cohort C: 50/50 mcg and Cohort D: 50/50 mcg) adjuvanted with 50 mcg monophosphoryl lipid A (MPL) and 500 mcg aluminum hydroxide \[Al(OH)3\]) or Placebo.
Participants by arm
| Arm | Count |
|---|---|
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg Norovirus bivalent VLP Vaccine (5 mcg of GI.1 norovirus VLP and 5 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years. | 10 |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg Norovirus bivalent VLP Vaccine (15 mcg of GI.1 norovirus VLP and 15 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years. | 10 |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years. | 10 |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg Norovirus bivalent VLP Vaccine (150 mcg of GI.1 norovirus VLP and 150 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years. | 9 |
| Cohort A1-A4: Placebo Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years. | 9 |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 50-64 years. | 9 |
| Cohort B: Placebo Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 50-64 years. | 10 |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 65-85 years. | 10 |
| Cohort C: Placebo Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 65-85 years. | 9 |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg Norovirus bivalent VLP Vaccine (50 mcg of GI.1 norovirus VLP and 50 mcg of GII.4 norovirus VLP) adjuvanted with 50 mcg MPL and 500 mcg Al(OH)3, injection, intramuscularly, on Days 0 and 28 in participants aged 18-49 years. | 8 |
| Cohort D: Placebo Norovirus Bivalent VLP Placebo-matching injection (0.9% NaCl and preservative-free), intramuscularly, on Days 0 and 28 in participants aged 18-49 years. | 8 |
| Total | 102 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Cohort A1-A4: Placebo | Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Cohort B: Placebo | Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Cohort C: Placebo | Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Cohort D: Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized >=65 years | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 10 participants | 9 participants | 0 participants | 0 participants | 19 participants |
| Age, Customized Greater than or equal to (>=) 18 and <64 years | 10 participants | 10 participants | 10 participants | 9 participants | 9 participants | 9 participants | 10 participants | 0 participants | 0 participants | 8 participants | 8 participants | 83 participants |
| Blood Type Blood Type A | 3 Participants | 3 Participants | 5 Participants | 3 Participants | 2 Participants | 2 Participants | 6 Participants | 3 Participants | 2 Participants | 1 Participants | 2 Participants | 32 Participants |
| Blood Type Blood Type AB | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 6 Participants |
| Blood Type Blood Type B | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants | 2 Participants | 11 Participants |
| Blood Type Blood Type O | 6 Participants | 4 Participants | 5 Participants | 5 Participants | 5 Participants | 5 Participants | 3 Participants | 7 Participants | 5 Participants | 5 Participants | 3 Participants | 53 Participants |
| Ethnicity Hispanic | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 5 Participants |
| Ethnicity Non-Hispanic | 8 Participants | 10 Participants | 10 Participants | 9 Participants | 9 Participants | 9 Participants | 9 Participants | 10 Participants | 9 Participants | 6 Participants | 8 Participants | 97 Participants |
| Race American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race Asian | 0 Participants | 0 Participants | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants |
| Race Black or African American | 2 Participants | 2 Participants | 2 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 5 Participants | 5 Participants | 19 Participants |
| Race More than one race | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race White | 8 Participants | 7 Participants | 6 Participants | 6 Participants | 7 Participants | 9 Participants | 9 Participants | 10 Participants | 9 Participants | 3 Participants | 2 Participants | 76 Participants |
| Region of Enrollment United States | 10 participants | 10 participants | 10 participants | 9 participants | 9 participants | 9 participants | 10 participants | 10 participants | 9 participants | 8 participants | 8 participants | 102 participants |
| Saliva Secretor Status Saliva Secretor Status Negative | 3 Participants | 2 Participants | 4 Participants | 0 Participants | 1 Participants | 3 Participants | 2 Participants | 2 Participants | 2 Participants | 1 Participants | 3 Participants | 23 Participants |
| Saliva Secretor Status Saliva Secretor Status Positive | 7 Participants | 8 Participants | 6 Participants | 9 Participants | 8 Participants | 6 Participants | 8 Participants | 8 Participants | 7 Participants | 7 Participants | 5 Participants | 79 Participants |
| Sex: Female, Male Female | 7 Participants | 6 Participants | 7 Participants | 7 Participants | 8 Participants | 5 Participants | 5 Participants | 8 Participants | 5 Participants | 3 Participants | 7 Participants | 68 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 3 Participants | 2 Participants | 1 Participants | 4 Participants | 5 Participants | 2 Participants | 4 Participants | 5 Participants | 1 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 8 / 10 | 5 / 10 | 5 / 10 | 3 / 9 | 3 / 9 | 5 / 9 | 3 / 10 | 4 / 10 | 5 / 9 | 5 / 8 | 5 / 8 |
| serious Total, serious adverse events | 1 / 10 | 0 / 10 | 1 / 10 | 0 / 9 | 0 / 9 | 0 / 9 | 1 / 10 | 2 / 10 | 0 / 9 | 0 / 8 | 0 / 8 |
Outcome results
Primary
Number of Participants With Clinically Significant Change From Baseline in Markedly Abnormal Laboratory Values
The number of participants with any markedly abnormal standard safety laboratory values (serum chemistry or hematology) collected throughout study.
Time frame: Baseline up to Day 35
Population: mITT population included all participants who received at least 1 dose of study product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Clinically Significant Change From Baseline in Markedly Abnormal Laboratory Values | 0 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Clinically Significant Change From Baseline in Markedly Abnormal Laboratory Values | 3 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Clinically Significant Change From Baseline in Markedly Abnormal Laboratory Values | 1 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Clinically Significant Change From Baseline in Markedly Abnormal Laboratory Values | 0 participants |
| Cohort A1-A4: Placebo | Number of Participants With Clinically Significant Change From Baseline in Markedly Abnormal Laboratory Values | 0 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Clinically Significant Change From Baseline in Markedly Abnormal Laboratory Values | 0 participants |
| Cohort B: Placebo | Number of Participants With Clinically Significant Change From Baseline in Markedly Abnormal Laboratory Values | 0 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Clinically Significant Change From Baseline in Markedly Abnormal Laboratory Values | 0 participants |
| Cohort C: Placebo | Number of Participants With Clinically Significant Change From Baseline in Markedly Abnormal Laboratory Values | 0 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Clinically Significant Change From Baseline in Markedly Abnormal Laboratory Values | 0 participants |
| Cohort D: Placebo | Number of Participants With Clinically Significant Change From Baseline in Markedly Abnormal Laboratory Values | 2 participants |
Primary
Number of Participants With Serious Adverse Events (SAEs), Onset of Significant New Medical Conditions, Including Adverse Events of Special Interest (AESI)
Time frame: Baseline up to 365 Days after post dose 2 (Day 393)
Population: mITT population included all participants who received at least 1 dose of study product.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Serious Adverse Events (SAEs), Onset of Significant New Medical Conditions, Including Adverse Events of Special Interest (AESI) | SAE | 1 participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Serious Adverse Events (SAEs), Onset of Significant New Medical Conditions, Including Adverse Events of Special Interest (AESI) | New Medical Conditions | 0 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Serious Adverse Events (SAEs), Onset of Significant New Medical Conditions, Including Adverse Events of Special Interest (AESI) | SAE | 0 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Serious Adverse Events (SAEs), Onset of Significant New Medical Conditions, Including Adverse Events of Special Interest (AESI) | New Medical Conditions | 0 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Serious Adverse Events (SAEs), Onset of Significant New Medical Conditions, Including Adverse Events of Special Interest (AESI) | New Medical Conditions | 0 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Serious Adverse Events (SAEs), Onset of Significant New Medical Conditions, Including Adverse Events of Special Interest (AESI) | SAE | 1 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Serious Adverse Events (SAEs), Onset of Significant New Medical Conditions, Including Adverse Events of Special Interest (AESI) | New Medical Conditions | 0 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Serious Adverse Events (SAEs), Onset of Significant New Medical Conditions, Including Adverse Events of Special Interest (AESI) | SAE | 0 participants |
| Cohort A1-A4: Placebo | Number of Participants With Serious Adverse Events (SAEs), Onset of Significant New Medical Conditions, Including Adverse Events of Special Interest (AESI) | SAE | 0 participants |
| Cohort A1-A4: Placebo | Number of Participants With Serious Adverse Events (SAEs), Onset of Significant New Medical Conditions, Including Adverse Events of Special Interest (AESI) | New Medical Conditions | 0 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Serious Adverse Events (SAEs), Onset of Significant New Medical Conditions, Including Adverse Events of Special Interest (AESI) | New Medical Conditions | 0 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Serious Adverse Events (SAEs), Onset of Significant New Medical Conditions, Including Adverse Events of Special Interest (AESI) | SAE | 0 participants |
| Cohort B: Placebo | Number of Participants With Serious Adverse Events (SAEs), Onset of Significant New Medical Conditions, Including Adverse Events of Special Interest (AESI) | New Medical Conditions | 0 participants |
| Cohort B: Placebo | Number of Participants With Serious Adverse Events (SAEs), Onset of Significant New Medical Conditions, Including Adverse Events of Special Interest (AESI) | SAE | 1 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Serious Adverse Events (SAEs), Onset of Significant New Medical Conditions, Including Adverse Events of Special Interest (AESI) | New Medical Conditions | 0 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Serious Adverse Events (SAEs), Onset of Significant New Medical Conditions, Including Adverse Events of Special Interest (AESI) | SAE | 2 participants |
| Cohort C: Placebo | Number of Participants With Serious Adverse Events (SAEs), Onset of Significant New Medical Conditions, Including Adverse Events of Special Interest (AESI) | SAE | 0 participants |
| Cohort C: Placebo | Number of Participants With Serious Adverse Events (SAEs), Onset of Significant New Medical Conditions, Including Adverse Events of Special Interest (AESI) | New Medical Conditions | 0 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Serious Adverse Events (SAEs), Onset of Significant New Medical Conditions, Including Adverse Events of Special Interest (AESI) | SAE | 0 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Serious Adverse Events (SAEs), Onset of Significant New Medical Conditions, Including Adverse Events of Special Interest (AESI) | New Medical Conditions | 0 participants |
| Cohort D: Placebo | Number of Participants With Serious Adverse Events (SAEs), Onset of Significant New Medical Conditions, Including Adverse Events of Special Interest (AESI) | New Medical Conditions | 0 participants |
| Cohort D: Placebo | Number of Participants With Serious Adverse Events (SAEs), Onset of Significant New Medical Conditions, Including Adverse Events of Special Interest (AESI) | SAE | 0 participants |
Primary
Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1
The solicited local adverse events were reported using a memory aid. Pain was scaled as Mild (did not interfere with activity); Moderate (repeated use of non-narcotic pain reliever greater than (\>) 24 hours \[24h\] or interfered with activity); and Severe (any use of narcotic pain reliever or prevented daily activity). Tenderness was scaled as Mild (mild discomfort to touch); Moderate (discomfort with movement); and Severe (significant discomfort at rest). Swelling and redness were scaled as Mild (2.5-5 centimeter \[cm\] and did not interfere with activity); Moderate (5.1-10 cm or interfered with activity); and Severe (\>10 cm or prevented daily activity).
Time frame: Day 0 up to Day 7
Population: mITT population included all participants who received at least 1 dose of study product. Only those categories have been reported below where at least 1 participant experienced the event.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Pain: Mild | 4 participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Swelling: Mild | 1 participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Tenderness: Moderate | 3 participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Tenderness: Mild | 4 participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Pain: Moderate | 4 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Pain: Moderate | 2 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Tenderness: Moderate | 4 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Pain: Mild | 5 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Swelling: Mild | 2 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Tenderness: Mild | 5 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Pain: Mild | 6 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Tenderness: Moderate | 2 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Pain: Moderate | 2 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Tenderness: Mild | 6 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Swelling: Mild | 2 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Pain: Moderate | 2 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Pain: Mild | 5 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Swelling: Mild | 1 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Tenderness: Moderate | 2 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Tenderness: Mild | 5 participants |
| Cohort A1-A4: Placebo | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Pain: Mild | 1 participants |
| Cohort A1-A4: Placebo | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Pain: Moderate | 0 participants |
| Cohort A1-A4: Placebo | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Tenderness: Mild | 1 participants |
| Cohort A1-A4: Placebo | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Tenderness: Moderate | 0 participants |
| Cohort A1-A4: Placebo | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Swelling: Mild | 0 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Pain: Mild | 5 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Tenderness: Mild | 4 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Pain: Moderate | 2 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Tenderness: Moderate | 2 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Swelling: Mild | 1 participants |
| Cohort B: Placebo | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Pain: Moderate | 0 participants |
| Cohort B: Placebo | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Pain: Mild | 0 participants |
| Cohort B: Placebo | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Swelling: Mild | 1 participants |
| Cohort B: Placebo | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Tenderness: Mild | 1 participants |
| Cohort B: Placebo | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Tenderness: Moderate | 0 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Tenderness: Mild | 6 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Pain: Moderate | 0 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Tenderness: Moderate | 0 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Pain: Mild | 4 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Swelling: Mild | 1 participants |
| Cohort C: Placebo | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Tenderness: Mild | 0 participants |
| Cohort C: Placebo | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Pain: Moderate | 0 participants |
| Cohort C: Placebo | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Pain: Mild | 0 participants |
| Cohort C: Placebo | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Tenderness: Moderate | 0 participants |
| Cohort C: Placebo | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Swelling: Mild | 0 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Pain: Moderate | 0 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Tenderness: Moderate | 1 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Pain: Mild | 4 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Swelling: Mild | 3 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Tenderness: Mild | 3 participants |
| Cohort D: Placebo | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Pain: Moderate | 0 participants |
| Cohort D: Placebo | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Swelling: Mild | 3 participants |
| Cohort D: Placebo | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Pain: Mild | 0 participants |
| Cohort D: Placebo | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Tenderness: Mild | 2 participants |
| Cohort D: Placebo | Number of Participants With Solicited Local Adverse Events (AEs) Post Dose 1 | Tenderness: Moderate | 0 participants |
Primary
Number of Participants With Solicited Local AEs Post Dose 2
The solicited local adverse events were reported using a memory aid. Pain was scaled as Mild (did not interfered with activity); Moderate (repeated use of non-narcotic pain reliever \>24h or interfered with activity); and Severe (any use of narcotic pain reliever or prevented daily activity). Tenderness was scaled as Mild (mild discomfort to touch); Moderate (discomfort with movement); and Severe (significant discomfort at rest). Swelling and redness were scaled as Mild (2.5-5 cm and did not interfere with activity); Moderate (5.1-10 cm or interfered with activity); and Severe (\>10 cm or prevented daily activity).
Time frame: Day 28 up to Day 35
Population: mITT population where Day 28 to 35 assessment were available for this measure. mITT population included all participants who received at least 1 dose of study product. Only those categories have been reported below where at least 1 participant experienced the event.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Swelling: Moderate | 1 participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Pain: Moderate | 3 participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Swelling: Mild | 0 participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Redness: Mild | 1 participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Tenderness: Moderate | 1 participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Pain: Mild | 5 participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Tenderness: Mild | 7 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Redness: Mild | 0 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Swelling: Moderate | 0 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Pain: Mild | 4 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Pain: Moderate | 1 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Swelling: Mild | 0 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Tenderness: Moderate | 1 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Tenderness: Mild | 6 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Swelling: Moderate | 0 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Pain: Mild | 4 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Pain: Moderate | 0 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Tenderness: Mild | 6 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Tenderness: Moderate | 0 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Swelling: Mild | 1 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Redness: Mild | 0 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Tenderness: Mild | 3 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Pain: Moderate | 0 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Redness: Mild | 0 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Swelling: Moderate | 0 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Swelling: Mild | 1 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Pain: Mild | 2 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Tenderness: Moderate | 0 participants |
| Cohort A1-A4: Placebo | Number of Participants With Solicited Local AEs Post Dose 2 | Pain: Moderate | 0 participants |
| Cohort A1-A4: Placebo | Number of Participants With Solicited Local AEs Post Dose 2 | Tenderness: Mild | 1 participants |
| Cohort A1-A4: Placebo | Number of Participants With Solicited Local AEs Post Dose 2 | Tenderness: Moderate | 0 participants |
| Cohort A1-A4: Placebo | Number of Participants With Solicited Local AEs Post Dose 2 | Pain: Mild | 0 participants |
| Cohort A1-A4: Placebo | Number of Participants With Solicited Local AEs Post Dose 2 | Swelling: Mild | 0 participants |
| Cohort A1-A4: Placebo | Number of Participants With Solicited Local AEs Post Dose 2 | Swelling: Moderate | 0 participants |
| Cohort A1-A4: Placebo | Number of Participants With Solicited Local AEs Post Dose 2 | Redness: Mild | 0 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Tenderness: Mild | 6 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Tenderness: Moderate | 1 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Swelling: Moderate | 0 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Pain: Moderate | 2 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Swelling: Mild | 0 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Redness: Mild | 0 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Pain: Mild | 3 participants |
| Cohort B: Placebo | Number of Participants With Solicited Local AEs Post Dose 2 | Swelling: Mild | 0 participants |
| Cohort B: Placebo | Number of Participants With Solicited Local AEs Post Dose 2 | Swelling: Moderate | 0 participants |
| Cohort B: Placebo | Number of Participants With Solicited Local AEs Post Dose 2 | Pain: Moderate | 0 participants |
| Cohort B: Placebo | Number of Participants With Solicited Local AEs Post Dose 2 | Tenderness: Mild | 1 participants |
| Cohort B: Placebo | Number of Participants With Solicited Local AEs Post Dose 2 | Tenderness: Moderate | 0 participants |
| Cohort B: Placebo | Number of Participants With Solicited Local AEs Post Dose 2 | Pain: Mild | 0 participants |
| Cohort B: Placebo | Number of Participants With Solicited Local AEs Post Dose 2 | Redness: Mild | 0 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Redness: Mild | 0 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Tenderness: Moderate | 0 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Pain: Moderate | 0 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Swelling: Moderate | 0 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Swelling: Mild | 0 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Tenderness: Mild | 4 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Pain: Mild | 5 participants |
| Cohort C: Placebo | Number of Participants With Solicited Local AEs Post Dose 2 | Redness: Mild | 0 participants |
| Cohort C: Placebo | Number of Participants With Solicited Local AEs Post Dose 2 | Tenderness: Mild | 0 participants |
| Cohort C: Placebo | Number of Participants With Solicited Local AEs Post Dose 2 | Pain: Mild | 0 participants |
| Cohort C: Placebo | Number of Participants With Solicited Local AEs Post Dose 2 | Tenderness: Moderate | 0 participants |
| Cohort C: Placebo | Number of Participants With Solicited Local AEs Post Dose 2 | Pain: Moderate | 0 participants |
| Cohort C: Placebo | Number of Participants With Solicited Local AEs Post Dose 2 | Swelling: Moderate | 0 participants |
| Cohort C: Placebo | Number of Participants With Solicited Local AEs Post Dose 2 | Swelling: Mild | 0 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Swelling: Mild | 4 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Pain: Mild | 3 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Tenderness: Mild | 5 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Tenderness: Moderate | 0 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Swelling: Moderate | 0 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Redness: Mild | 0 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Solicited Local AEs Post Dose 2 | Pain: Moderate | 1 participants |
| Cohort D: Placebo | Number of Participants With Solicited Local AEs Post Dose 2 | Pain: Moderate | 0 participants |
| Cohort D: Placebo | Number of Participants With Solicited Local AEs Post Dose 2 | Swelling: Moderate | 0 participants |
| Cohort D: Placebo | Number of Participants With Solicited Local AEs Post Dose 2 | Redness: Mild | 0 participants |
| Cohort D: Placebo | Number of Participants With Solicited Local AEs Post Dose 2 | Tenderness: Mild | 2 participants |
| Cohort D: Placebo | Number of Participants With Solicited Local AEs Post Dose 2 | Tenderness: Moderate | 0 participants |
| Cohort D: Placebo | Number of Participants With Solicited Local AEs Post Dose 2 | Pain: Mild | 1 participants |
| Cohort D: Placebo | Number of Participants With Solicited Local AEs Post Dose 2 | Swelling: Mild | 5 participants |
Primary
Number of Participants With Solicited Systemic AEs Post Dose 1
Elevated oral temperature:Mild(38-38.4 Celsius\[C\]);Moderate(38.5-38.9 C);Severe(39-40 C).Headache:Mild(no interference with activity);Moderate(repeated use of non-narcotic pain reliever\>24h/some interference with activity);Severe(significant;any use of narcotic pain reliever/prevented daily activity).Fatigue,Malaise:Mild(no interference with activity);Moderate(some interference with activity);Severe(significant;prevented daily activity).Diarrhea:Mild(2-3loose stools/\<400gram\[g\]/24h);Moderate(4-5stools/400-800g/24h);Severe(\>=6watery stools/\>800g/24h/required intravenous\[IV\]hydration).Nausea/Vomiting:Mild(no interference with activity/1-2 episodes/24h);Moderate(some interference with activity/\>2 episodes/24h);Severe(prevented daily activity,required IV hydration).Muscle ache,chills,joint ache,abdominal cramp/pain:Mild(no interference with activity);Moderate(some interference with activity,not required medical intervention);Severe(prevented daily activity,required medical intervention).
Time frame: Day 0 up to Day 7
Population: mITT population included all participants who received at least 1 dose of study product. Only those categories have been reported below where at least 1 participant experienced the event.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Joint Aches: Mild | 1 participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Muscle Aches : Moderate | 1 participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Chills: Moderate | 1 participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Abdominal Cramps/Discomfort: Moderate | 2 participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Muscle Aches : Mild | 4 participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Headache: Moderate | 3 participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Chills: Mild | 1 participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Nausea: Moderate | 2 participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Diarrhea: Moderate | 1 participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Joint Aches: Moderate | 2 participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Diarrhea: Mild | 2 participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Fatigue/ Malaise: Mild | 1 participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Abdominal Cramps/Discomfort: Mild | 2 participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Nausea: Mild | 1 participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Vomiting: Moderate | 1 participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Headache: Mild | 1 participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Diarrhea: Severe | 0 participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Fatigue/ Malaise: Moderate | 4 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Vomiting: Moderate | 0 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Muscle Aches : Moderate | 0 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Nausea: Moderate | 0 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Chills: Moderate | 0 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Fatigue/ Malaise: Moderate | 1 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Diarrhea: Mild | 0 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Joint Aches: Mild | 1 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Chills: Mild | 0 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Abdominal Cramps/Discomfort: Mild | 0 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Muscle Aches : Mild | 2 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Diarrhea: Severe | 0 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Abdominal Cramps/Discomfort: Moderate | 0 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Fatigue/ Malaise: Mild | 1 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Headache: Moderate | 1 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Nausea: Mild | 1 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Joint Aches: Moderate | 0 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Headache: Mild | 3 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Diarrhea: Moderate | 0 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Fatigue/ Malaise: Moderate | 1 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Joint Aches: Moderate | 1 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Diarrhea: Severe | 0 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Diarrhea: Moderate | 0 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Headache: Moderate | 0 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Diarrhea: Mild | 1 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Fatigue/ Malaise: Mild | 1 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Headache: Mild | 3 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Vomiting: Moderate | 0 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Chills: Moderate | 1 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Nausea: Mild | 2 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Chills: Mild | 1 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Muscle Aches : Mild | 1 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Abdominal Cramps/Discomfort: Moderate | 0 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Abdominal Cramps/Discomfort: Mild | 1 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Muscle Aches : Moderate | 1 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Nausea: Moderate | 0 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Joint Aches: Mild | 0 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Nausea: Mild | 1 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Headache: Mild | 2 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Fatigue/ Malaise: Moderate | 0 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Joint Aches: Mild | 0 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Muscle Aches : Moderate | 0 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Chills: Moderate | 0 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Vomiting: Moderate | 0 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Fatigue/ Malaise: Mild | 1 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Nausea: Moderate | 0 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Diarrhea: Severe | 0 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Diarrhea: Mild | 1 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Headache: Moderate | 1 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Diarrhea: Moderate | 0 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Abdominal Cramps/Discomfort: Moderate | 0 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Joint Aches: Moderate | 0 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Muscle Aches : Mild | 3 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Chills: Mild | 0 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Abdominal Cramps/Discomfort: Mild | 2 participants |
| Cohort A1-A4: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Muscle Aches : Mild | 1 participants |
| Cohort A1-A4: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Headache: Mild | 2 participants |
| Cohort A1-A4: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Headache: Moderate | 0 participants |
| Cohort A1-A4: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Fatigue/ Malaise: Mild | 0 participants |
| Cohort A1-A4: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Fatigue/ Malaise: Moderate | 0 participants |
| Cohort A1-A4: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Muscle Aches : Moderate | 0 participants |
| Cohort A1-A4: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Joint Aches: Mild | 0 participants |
| Cohort A1-A4: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Joint Aches: Moderate | 0 participants |
| Cohort A1-A4: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Nausea: Mild | 1 participants |
| Cohort A1-A4: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Nausea: Moderate | 0 participants |
| Cohort A1-A4: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Abdominal Cramps/Discomfort: Mild | 0 participants |
| Cohort A1-A4: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Abdominal Cramps/Discomfort: Moderate | 1 participants |
| Cohort A1-A4: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Chills: Mild | 0 participants |
| Cohort A1-A4: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Chills: Moderate | 0 participants |
| Cohort A1-A4: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Diarrhea: Moderate | 0 participants |
| Cohort A1-A4: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Vomiting: Moderate | 0 participants |
| Cohort A1-A4: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Diarrhea: Mild | 0 participants |
| Cohort A1-A4: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Diarrhea: Severe | 1 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Fatigue/ Malaise: Moderate | 0 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Vomiting: Moderate | 0 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Chills: Mild | 0 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Muscle Aches : Moderate | 0 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Fatigue/ Malaise: Mild | 2 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Nausea: Mild | 1 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Headache: Mild | 5 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Abdominal Cramps/Discomfort: Mild | 0 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Diarrhea: Severe | 0 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Joint Aches: Mild | 0 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Nausea: Moderate | 0 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Diarrhea: Moderate | 0 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Joint Aches: Moderate | 0 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Chills: Moderate | 0 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Headache: Moderate | 0 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Diarrhea: Mild | 0 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Muscle Aches : Mild | 0 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Abdominal Cramps/Discomfort: Moderate | 0 participants |
| Cohort B: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Diarrhea: Severe | 0 participants |
| Cohort B: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Abdominal Cramps/Discomfort: Moderate | 1 participants |
| Cohort B: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Fatigue/ Malaise: Moderate | 0 participants |
| Cohort B: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Chills: Mild | 0 participants |
| Cohort B: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Diarrhea: Moderate | 1 participants |
| Cohort B: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Headache: Moderate | 0 participants |
| Cohort B: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Diarrhea: Mild | 0 participants |
| Cohort B: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Headache: Mild | 0 participants |
| Cohort B: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Nausea: Moderate | 0 participants |
| Cohort B: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Nausea: Mild | 1 participants |
| Cohort B: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Vomiting: Moderate | 0 participants |
| Cohort B: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Muscle Aches : Moderate | 0 participants |
| Cohort B: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Fatigue/ Malaise: Mild | 1 participants |
| Cohort B: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Abdominal Cramps/Discomfort: Mild | 0 participants |
| Cohort B: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Joint Aches: Mild | 0 participants |
| Cohort B: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Chills: Moderate | 0 participants |
| Cohort B: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Joint Aches: Moderate | 0 participants |
| Cohort B: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Muscle Aches : Mild | 0 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Fatigue/ Malaise: Mild | 0 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Headache: Mild | 2 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Nausea: Mild | 0 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Muscle Aches : Moderate | 1 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Nausea: Moderate | 0 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Abdominal Cramps/Discomfort: Mild | 1 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Muscle Aches : Mild | 0 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Abdominal Cramps/Discomfort: Moderate | 0 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Chills: Moderate | 0 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Fatigue/ Malaise: Moderate | 0 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Chills: Mild | 0 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Diarrhea: Severe | 0 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Vomiting: Moderate | 0 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Headache: Moderate | 0 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Diarrhea: Mild | 1 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Diarrhea: Moderate | 0 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Joint Aches: Moderate | 0 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Joint Aches: Mild | 0 participants |
| Cohort C: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Muscle Aches : Mild | 0 participants |
| Cohort C: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Joint Aches: Mild | 0 participants |
| Cohort C: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Vomiting: Moderate | 0 participants |
| Cohort C: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Fatigue/ Malaise: Moderate | 0 participants |
| Cohort C: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Nausea: Moderate | 0 participants |
| Cohort C: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Joint Aches: Moderate | 0 participants |
| Cohort C: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Chills: Moderate | 0 participants |
| Cohort C: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Headache: Moderate | 0 participants |
| Cohort C: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Chills: Mild | 0 participants |
| Cohort C: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Diarrhea: Moderate | 0 participants |
| Cohort C: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Fatigue/ Malaise: Mild | 0 participants |
| Cohort C: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Nausea: Mild | 1 participants |
| Cohort C: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Abdominal Cramps/Discomfort: Moderate | 0 participants |
| Cohort C: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Abdominal Cramps/Discomfort: Mild | 1 participants |
| Cohort C: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Headache: Mild | 2 participants |
| Cohort C: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Diarrhea: Mild | 1 participants |
| Cohort C: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Diarrhea: Severe | 0 participants |
| Cohort C: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Muscle Aches : Moderate | 0 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Diarrhea: Moderate | 0 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Fatigue/ Malaise: Mild | 0 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Chills: Moderate | 0 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Abdominal Cramps/Discomfort: Mild | 1 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Muscle Aches : Mild | 0 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Nausea: Moderate | 0 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Vomiting: Moderate | 0 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Headache: Moderate | 0 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Diarrhea: Severe | 0 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Joint Aches: Moderate | 0 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Diarrhea: Mild | 1 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Muscle Aches : Moderate | 0 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Headache: Mild | 0 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Abdominal Cramps/Discomfort: Moderate | 0 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Joint Aches: Mild | 0 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Fatigue/ Malaise: Moderate | 0 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Nausea: Mild | 0 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 1 | Chills: Mild | 0 participants |
| Cohort D: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Headache: Mild | 2 participants |
| Cohort D: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Fatigue/ Malaise: Moderate | 0 participants |
| Cohort D: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Nausea: Mild | 0 participants |
| Cohort D: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Joint Aches: Moderate | 0 participants |
| Cohort D: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Chills: Moderate | 0 participants |
| Cohort D: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Abdominal Cramps/Discomfort: Moderate | 0 participants |
| Cohort D: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Diarrhea: Moderate | 0 participants |
| Cohort D: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Joint Aches: Mild | 0 participants |
| Cohort D: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Headache: Moderate | 1 participants |
| Cohort D: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Chills: Mild | 0 participants |
| Cohort D: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Vomiting: Moderate | 0 participants |
| Cohort D: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Nausea: Moderate | 0 participants |
| Cohort D: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Abdominal Cramps/Discomfort: Mild | 0 participants |
| Cohort D: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Muscle Aches : Mild | 0 participants |
| Cohort D: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Diarrhea: Severe | 0 participants |
| Cohort D: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Diarrhea: Mild | 2 participants |
| Cohort D: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Fatigue/ Malaise: Mild | 1 participants |
| Cohort D: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 1 | Muscle Aches : Moderate | 0 participants |
Primary
Number of Participants With Solicited Systemic AEs Post Dose 2
Elevated oral temperature:Mild(38-38.4 C);Moderate(38.5-38.9 C);Severe(39-40 C).Headache:Mild(no interference with activity);Moderate(repeated use of non-narcotic pain reliever\>24h/some interference with activity);Severe(significant;any use of narcotic pain reliever/prevented daily activity).Fatigue,Malaise:Mild(no interference with activity);Moderate(some interference with activity);Severe(significant;prevented daily activity).Diarrhea:Mild(2-3loose stools/\<400g/24h);Moderate(4-5stools/400-800g/24h);Severe(\>=6watery stools/\>800g/24h/required IV hydration).Nausea/Vomiting:Mild(no interference with activity/1-2 episodes/24h);Moderate(some interference with activity/\>2 episodes/24h);Severe(prevented daily activity,required IV hydration).Muscle ache,chills,joint ache,abdominal cramp/pain:Mild(no interference with activity);Moderate(some interference with activity,not required medical intervention);Severe(prevented daily activity,required medical intervention).
Time frame: Day 28 up to Day 35
Population: mITT population where Day 28 to 35 assessment were available for this measure. mITT population included all participants who received at least 1 dose of study product. Only those categories have been reported below where at least 1 participant experienced the event.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Joint Aches: Moderate | 0 participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Diarrhea: Severe | 1 participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Nausea: Mild | 1 participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Chills: Mild | 0 participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Nausea: Moderate | 1 participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Headache: Severe | 0 participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Chills: Moderate | 1 participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Joint Aches: Mild | 1 participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Fatigue/ Malaise: Moderate | 2 participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Abdominal Cramps/Discomfort: Mild | 1 participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Diarrhea: Mild | 0 participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Muscle Aches: Mild | 2 participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Fatigue/ Malaise: Mild | 1 participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Headache: Mild | 1 participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Headache: Moderate | 2 participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Muscle Aches: Moderate | 1 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Nausea: Moderate | 0 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Chills: Moderate | 0 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Muscle Aches: Mild | 1 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Headache: Mild | 1 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Abdominal Cramps/Discomfort: Mild | 1 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Diarrhea: Mild | 0 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Headache: Moderate | 0 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Nausea: Mild | 0 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Headache: Severe | 0 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Joint Aches: Moderate | 0 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Diarrhea: Severe | 0 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Fatigue/ Malaise: Mild | 0 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Chills: Mild | 0 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Joint Aches: Mild | 0 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Muscle Aches: Moderate | 0 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Fatigue/ Malaise: Moderate | 0 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Headache: Moderate | 1 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Chills: Moderate | 0 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Diarrhea: Severe | 0 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Diarrhea: Mild | 0 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Muscle Aches: Moderate | 0 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Fatigue/ Malaise: Mild | 3 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Headache: Mild | 3 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Joint Aches: Mild | 0 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Nausea: Mild | 0 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Muscle Aches: Mild | 3 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Headache: Severe | 0 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Chills: Mild | 1 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Fatigue/ Malaise: Moderate | 0 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Nausea: Moderate | 0 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Joint Aches: Moderate | 0 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Abdominal Cramps/Discomfort: Mild | 1 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Abdominal Cramps/Discomfort: Mild | 2 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Chills: Moderate | 0 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Diarrhea: Mild | 0 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Headache: Moderate | 0 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Headache: Severe | 0 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Fatigue/ Malaise: Mild | 0 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Fatigue/ Malaise: Moderate | 0 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Muscle Aches: Mild | 1 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Diarrhea: Severe | 0 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Muscle Aches: Moderate | 0 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Headache: Mild | 2 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Joint Aches: Moderate | 0 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Nausea: Mild | 0 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Nausea: Moderate | 0 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Chills: Mild | 0 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Joint Aches: Mild | 0 participants |
| Cohort A1-A4: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Nausea: Moderate | 0 participants |
| Cohort A1-A4: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Headache: Severe | 0 participants |
| Cohort A1-A4: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Headache: Moderate | 0 participants |
| Cohort A1-A4: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Nausea: Mild | 0 participants |
| Cohort A1-A4: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Muscle Aches: Moderate | 0 participants |
| Cohort A1-A4: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Fatigue/ Malaise: Moderate | 0 participants |
| Cohort A1-A4: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Diarrhea: Severe | 0 participants |
| Cohort A1-A4: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Chills: Mild | 0 participants |
| Cohort A1-A4: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Fatigue/ Malaise: Mild | 1 participants |
| Cohort A1-A4: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Joint Aches: Mild | 0 participants |
| Cohort A1-A4: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Headache: Mild | 1 participants |
| Cohort A1-A4: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Abdominal Cramps/Discomfort: Mild | 0 participants |
| Cohort A1-A4: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Diarrhea: Mild | 0 participants |
| Cohort A1-A4: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Muscle Aches: Mild | 0 participants |
| Cohort A1-A4: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Joint Aches: Moderate | 0 participants |
| Cohort A1-A4: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Chills: Moderate | 0 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Nausea: Moderate | 0 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Headache: Mild | 3 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Headache: Severe | 0 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Chills: Mild | 0 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Joint Aches: Mild | 0 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Headache: Moderate | 0 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Nausea: Mild | 1 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Diarrhea: Severe | 0 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Chills: Moderate | 0 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Muscle Aches: Mild | 0 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Diarrhea: Mild | 0 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Fatigue/ Malaise: Moderate | 0 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Abdominal Cramps/Discomfort: Mild | 1 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Joint Aches: Moderate | 0 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Muscle Aches: Moderate | 0 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Fatigue/ Malaise: Mild | 2 participants |
| Cohort B: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Muscle Aches: Mild | 0 participants |
| Cohort B: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Muscle Aches: Moderate | 0 participants |
| Cohort B: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Chills: Mild | 0 participants |
| Cohort B: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Fatigue/ Malaise: Mild | 0 participants |
| Cohort B: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Joint Aches: Mild | 0 participants |
| Cohort B: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Diarrhea: Severe | 0 participants |
| Cohort B: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Headache: Severe | 0 participants |
| Cohort B: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Joint Aches: Moderate | 0 participants |
| Cohort B: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Nausea: Mild | 0 participants |
| Cohort B: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Headache: Mild | 0 participants |
| Cohort B: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Headache: Moderate | 0 participants |
| Cohort B: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Nausea: Moderate | 0 participants |
| Cohort B: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Abdominal Cramps/Discomfort: Mild | 1 participants |
| Cohort B: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Diarrhea: Mild | 1 participants |
| Cohort B: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Chills: Moderate | 0 participants |
| Cohort B: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Fatigue/ Malaise: Moderate | 0 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Muscle Aches: Mild | 0 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Diarrhea: Severe | 0 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Joint Aches: Moderate | 0 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Chills: Mild | 0 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Nausea: Moderate | 0 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Headache: Mild | 1 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Diarrhea: Mild | 0 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Headache: Severe | 1 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Chills: Moderate | 0 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Muscle Aches: Moderate | 0 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Abdominal Cramps/Discomfort: Mild | 0 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Joint Aches: Mild | 0 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Fatigue/ Malaise: Mild | 0 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Nausea: Mild | 0 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Fatigue/ Malaise: Moderate | 0 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Headache: Moderate | 0 participants |
| Cohort C: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Headache: Moderate | 0 participants |
| Cohort C: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Diarrhea: Mild | 0 participants |
| Cohort C: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Joint Aches: Moderate | 1 participants |
| Cohort C: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Abdominal Cramps/Discomfort: Mild | 0 participants |
| Cohort C: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Headache: Mild | 1 participants |
| Cohort C: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Muscle Aches: Moderate | 1 participants |
| Cohort C: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Fatigue/ Malaise: Mild | 0 participants |
| Cohort C: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Nausea: Moderate | 0 participants |
| Cohort C: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Muscle Aches: Mild | 0 participants |
| Cohort C: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Nausea: Mild | 0 participants |
| Cohort C: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Fatigue/ Malaise: Moderate | 0 participants |
| Cohort C: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Diarrhea: Severe | 0 participants |
| Cohort C: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Chills: Moderate | 0 participants |
| Cohort C: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Chills: Mild | 0 participants |
| Cohort C: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Headache: Severe | 0 participants |
| Cohort C: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Joint Aches: Mild | 0 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Fatigue/ Malaise: Mild | 0 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Headache: Mild | 1 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Headache: Moderate | 0 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Headache: Severe | 0 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Fatigue/ Malaise: Moderate | 0 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Muscle Aches: Mild | 0 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Muscle Aches: Moderate | 0 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Joint Aches: Mild | 0 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Joint Aches: Moderate | 0 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Nausea: Mild | 0 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Nausea: Moderate | 0 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Abdominal Cramps/Discomfort: Mild | 0 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Chills: Mild | 0 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Chills: Moderate | 0 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Diarrhea: Mild | 0 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Solicited Systemic AEs Post Dose 2 | Diarrhea: Severe | 0 participants |
| Cohort D: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Abdominal Cramps/Discomfort: Mild | 0 participants |
| Cohort D: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Nausea: Moderate | 0 participants |
| Cohort D: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Nausea: Mild | 0 participants |
| Cohort D: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Diarrhea: Severe | 0 participants |
| Cohort D: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Diarrhea: Mild | 0 participants |
| Cohort D: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Joint Aches: Moderate | 0 participants |
| Cohort D: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Joint Aches: Mild | 0 participants |
| Cohort D: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Muscle Aches: Moderate | 0 participants |
| Cohort D: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Muscle Aches: Mild | 0 participants |
| Cohort D: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Fatigue/ Malaise: Moderate | 1 participants |
| Cohort D: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Fatigue/ Malaise: Mild | 0 participants |
| Cohort D: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Headache: Severe | 0 participants |
| Cohort D: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Headache: Moderate | 1 participants |
| Cohort D: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Headache: Mild | 1 participants |
| Cohort D: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Chills: Moderate | 0 participants |
| Cohort D: Placebo | Number of Participants With Solicited Systemic AEs Post Dose 2 | Chills: Mild | 0 participants |
Primary
Number of Participants With Unsolicited AEs Post Dose 1
Time frame: Baseline up to Day 28 (Pre-dose 2)
Population: mITT population included all participants who received at least 1 dose of study product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Unsolicited AEs Post Dose 1 | 7 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Unsolicited AEs Post Dose 1 | 4 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Unsolicited AEs Post Dose 1 | 4 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Unsolicited AEs Post Dose 1 | 1 participants |
| Cohort A1-A4: Placebo | Number of Participants With Unsolicited AEs Post Dose 1 | 2 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Unsolicited AEs Post Dose 1 | 4 participants |
| Cohort B: Placebo | Number of Participants With Unsolicited AEs Post Dose 1 | 0 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Unsolicited AEs Post Dose 1 | 3 participants |
| Cohort C: Placebo | Number of Participants With Unsolicited AEs Post Dose 1 | 3 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Unsolicited AEs Post Dose 1 | 3 participants |
| Cohort D: Placebo | Number of Participants With Unsolicited AEs Post Dose 1 | 4 participants |
Primary
Number of Participants With Unsolicited AEs Post Dose 2
Time frame: Day 28 up to Day 56 (Post dose 2)
Population: mITT population where Day 28 to 56 assessment were available for this measure. mITT population included all participants who received at least 1 dose of study product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Number of Participants With Unsolicited AEs Post Dose 2 | 2 participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Number of Participants With Unsolicited AEs Post Dose 2 | 1 participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Unsolicited AEs Post Dose 2 | 2 participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Number of Participants With Unsolicited AEs Post Dose 2 | 2 participants |
| Cohort A1-A4: Placebo | Number of Participants With Unsolicited AEs Post Dose 2 | 2 participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Unsolicited AEs Post Dose 2 | 3 participants |
| Cohort B: Placebo | Number of Participants With Unsolicited AEs Post Dose 2 | 3 participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Number of Participants With Unsolicited AEs Post Dose 2 | 2 participants |
| Cohort C: Placebo | Number of Participants With Unsolicited AEs Post Dose 2 | 2 participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Number of Participants With Unsolicited AEs Post Dose 2 | 3 participants |
| Cohort D: Placebo | Number of Participants With Unsolicited AEs Post Dose 2 | 1 participants |
Secondary
Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline
Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
Time frame: I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)
Population: PP population where baseline and specified post-baseline assessment were available. PP population included all participants who received both doses of study product and with no protocol deviations likely to affect the immunogenicity assessment.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: II Run:28 Days PD2 | 4.7 fold rise |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:28 Days PD1 | 16.2 fold rise |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:28 Days PD2 | 5.2 fold rise |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:7 Days PD2 | 5.2 fold rise |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: II Run:152 Days PD2 | 3.6 fold rise |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: II Run:365 Days PD2 | 4.1 fold rise |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:7 Days PD1 | 6.7 fold rise |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:28 Days PD2 | 13 fold rise |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: II Run:365 Days PD2 | 2 fold rise |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:21 Days PD1 | 5.7 fold rise |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: II Run:152 Days PD2 | 2.6 fold rise |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:21 Days PD1 | 18.5 fold rise |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:7 Days PD2 | 15.1 fold rise |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:7 Days PD1 | 23.1 fold rise |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: II Run:28 Days PD2 | 7 fold rise |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:28 Days PD1 | 5.6 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: II Run:365 Days PD2 | 3.7 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: II Run:152 Days PD2 | 4.1 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: II Run:152 Days PD2 | 4.8 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:21 Days PD1 | 34.9 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: II Run:28 Days PD2 | 7.5 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:7 Days PD2 | 6.1 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:28 Days PD1 | 22.6 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:28 Days PD1 | 5.5 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:7 Days PD2 | 22.5 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:21 Days PD1 | 9 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:28 Days PD2 | 16 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:7 Days PD1 | 15.4 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: II Run:365 Days PD2 | 3.1 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:7 Days PD1 | 76.1 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:28 Days PD2 | 5.2 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: II Run:28 Days PD2 | 5 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:7 Days PD1 | 84.4 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: II Run:152 Days PD2 | 2 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: II Run:365 Days PD2 | 2.6 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:7 Days PD2 | 23.9 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:21 Days PD1 | 5 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:7 Days PD1 | 10.7 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: II Run:365 Days PD2 | 1.7 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:28 Days PD2 | 12.1 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:28 Days PD2 | 3.4 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: II Run:28 Days PD2 | 3.6 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: II Run:152 Days PD2 | 3.3 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:7 Days PD2 | 3.2 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: II Run:28 Days PD2 | 3.9 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:28 Days PD1 | 33.7 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:28 Days PD1 | 3.6 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:21 Days PD1 | 49.6 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:28 Days PD1 | 25.4 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: II Run:152 Days PD2 | 1.9 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:21 Days PD1 | 2.7 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:28 Days PD2 | 13.2 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:21 Days PD1 | 52.1 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: II Run:365 Days PD2 | 4.5 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:7 Days PD2 | 22.2 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:28 Days PD2 | 2 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:28 Days PD1 | 2 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: II Run:365 Days PD2 | 1.8 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:7 Days PD1 | 122.9 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: II Run:28 Days PD2 | 2.5 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:7 Days PD1 | 5 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:7 Days PD2 | 2.5 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: II Run:152 Days PD2 | 4.6 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: II Run:28 Days PD2 | 4.7 fold rise |
| Cohort A1-A4: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:7 Days PD2 | 1.3 fold rise |
| Cohort A1-A4: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: II Run:28 Days PD2 | 1.5 fold rise |
| Cohort A1-A4: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: II Run:152 Days PD2 | 1.3 fold rise |
| Cohort A1-A4: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:21 Days PD1 | 1 fold rise |
| Cohort A1-A4: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:28 Days PD1 | 1 fold rise |
| Cohort A1-A4: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:7 Days PD2 | 1.1 fold rise |
| Cohort A1-A4: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:28 Days PD2 | 1 fold rise |
| Cohort A1-A4: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: II Run:365 Days PD2 | 1.3 fold rise |
| Cohort A1-A4: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: II Run:28 Days PD2 | 1 fold rise |
| Cohort A1-A4: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: II Run:152 Days PD2 | 1 fold rise |
| Cohort A1-A4: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: II Run:365 Days PD2 | 1 fold rise |
| Cohort A1-A4: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:7 Days PD1 | 0.8 fold rise |
| Cohort A1-A4: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:7 Days PD1 | 1 fold rise |
| Cohort A1-A4: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:21 Days PD1 | 0.9 fold rise |
| Cohort A1-A4: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:28 Days PD1 | 1 fold rise |
| Cohort A1-A4: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:28 Days PD2 | 1.3 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: II Run:152 Days PD2 | 18.5 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: II Run:152 Days PD2 | 2.8 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:28 Days PD1 | 57.5 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:7 Days PD1 | 115.2 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:21 Days PD1 | 6.6 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:7 Days PD2 | 45.2 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:28 Days PD2 | 3.5 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: II Run:28 Days PD2 | 4 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:21 Days PD1 | 81.2 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:7 Days PD2 | 4.6 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: II Run:28 Days PD2 | 38.6 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:28 Days PD2 | 31.3 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: II Run:365 Days PD2 | 1.8 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: II Run:365 Days PD2 | 12.2 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:28 Days PD1 | 4.5 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:7 Days PD1 | 9.7 fold rise |
| Cohort B: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: II Run:28 Days PD2 | 1 fold rise |
| Cohort B: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:28 Days PD2 | 1 fold rise |
| Cohort B: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: II Run:365 Days PD2 | 1 fold rise |
| Cohort B: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:28 Days PD2 | 1.1 fold rise |
| Cohort B: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:7 Days PD1 | 1 fold rise |
| Cohort B: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:7 Days PD1 | 1 fold rise |
| Cohort B: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:7 Days PD2 | 1 fold rise |
| Cohort B: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: II Run:365 Days PD2 | 1.5 fold rise |
| Cohort B: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:21 Days PD1 | 1.1 fold rise |
| Cohort B: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:28 Days PD1 | 1 fold rise |
| Cohort B: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:28 Days PD1 | 1 fold rise |
| Cohort B: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:7 Days PD2 | 1.1 fold rise |
| Cohort B: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:21 Days PD1 | 1 fold rise |
| Cohort B: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: II Run:152 Days PD2 | 1.2 fold rise |
| Cohort B: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: II Run:28 Days PD2 | 1.1 fold rise |
| Cohort B: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: II Run:152 Days PD2 | 1.1 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:7 Days PD2 | 2.4 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: II Run:28 Days PD2 | 25.5 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:28 Days PD1 | 2.4 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:28 Days PD1 | 19.6 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:28 Days PD2 | 2.3 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:7 Days PD1 | 4.4 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: II Run:28 Days PD2 | 2.4 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:7 Days PD2 | 19.7 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: II Run:152 Days PD2 | 1.6 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: II Run:365 Days PD2 | 1.3 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: II Run:365 Days PD2 | 8.8 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:21 Days PD1 | 24.2 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:21 Days PD1 | 3.5 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:28 Days PD2 | 14.2 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:7 Days PD1 | 39.1 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: II Run:152 Days PD2 | 12.9 fold rise |
| Cohort C: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: II Run:152 Days PD2 | 1.1 fold rise |
| Cohort C: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:7 Days PD1 | 1.2 fold rise |
| Cohort C: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:28 Days PD2 | 1.1 fold rise |
| Cohort C: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:28 Days PD1 | 1 fold rise |
| Cohort C: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:7 Days PD1 | 1 fold rise |
| Cohort C: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:21 Days PD1 | 1 fold rise |
| Cohort C: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:7 Days PD2 | 1.1 fold rise |
| Cohort C: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: II Run:152 Days PD2 | 1.1 fold rise |
| Cohort C: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:28 Days PD2 | 1 fold rise |
| Cohort C: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: II Run:28 Days PD2 | 1 fold rise |
| Cohort C: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: II Run:28 Days PD2 | 1 fold rise |
| Cohort C: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: II Run:365 Days PD2 | 1.4 fold rise |
| Cohort C: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:7 Days PD2 | 1 fold rise |
| Cohort C: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: II Run:365 Days PD2 | 1.3 fold rise |
| Cohort C: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:21 Days PD1 | 1.1 fold rise |
| Cohort C: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:28 Days PD1 | 1 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:7 Days PD2 | 6 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:7 Days PD1 | 12.6 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:21 Days PD1 | 9.7 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:28 Days PD1 | 6.6 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:28 Days PD2 | 5.3 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: II Run:28 Days PD2 | 9.6 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: II Run:152 Days PD2 | 6.6 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: II Run:365 Days PD2 | 5.2 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:7 Days PD1 | 19.9 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:21 Days PD1 | 11.4 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:28 Days PD1 | 8.1 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:7 Days PD2 | 7.5 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:28 Days PD2 | 6.4 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: II Run:28 Days PD2 | 8.1 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: II Run:152 Days PD2 | 4.8 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: II Run:365 Days PD2 | 4.4 fold rise |
| Cohort D: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:7 Days PD2 | 1 fold rise |
| Cohort D: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:28 Days PD1 | 1 fold rise |
| Cohort D: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:21 Days PD1 | 1 fold rise |
| Cohort D: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: II Run:365 Days PD2 | 0.8 fold rise |
| Cohort D: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: II Run:152 Days PD2 | 0.8 fold rise |
| Cohort D: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:7 Days PD1 | 1 fold rise |
| Cohort D: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: II Run:365 Days PD2 | 1 fold rise |
| Cohort D: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: II Run:152 Days PD2 | 1.1 fold rise |
| Cohort D: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: II Run:28 Days PD2 | 1.1 fold rise |
| Cohort D: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:28 Days PD2 | 1 fold rise |
| Cohort D: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:7 Days PD2 | 1 fold rise |
| Cohort D: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:28 Days PD1 | 1 fold rise |
| Cohort D: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:21 Days PD1 | 1 fold rise |
| Cohort D: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GI.1: I Run:7 Days PD1 | 1 fold rise |
| Cohort D: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: II Run:28 Days PD2 | 1 fold rise |
| Cohort D: Placebo | Geometric Mean Fold Rise (GMFR) of Serum Anti-norovirus GI.1 and GII.4 VLP IgA as Compared to Baseline | GII.4: I Run:28 Days PD2 | 1.1 fold rise |
Secondary
Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A
Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
Time frame: First (I) run: predose 1 and 7, 21, 28 days postdose (PD)1, and 7 and 28 days PD2; second (II) run: predose 1 and 28, 152 and 365 days PD2 (up to Day 393)
Population: Per Protocol (PP) population included all participants who received both doses of study product and with no protocol deviations likely to affect the immunogenicity assessment.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: II Run:152 Days PD2 | 17 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: II Run:28 Days PD2 | 32 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: II Run:Pre-Dose 1 | 5 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: II Run:365 Days PD2 | 16 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:7 Days PD1 | 204 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: II Run:152 Days PD2 | 25 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: II Run:28 Days PD2 | 39 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:21 Days PD1 | 164 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: II Run:Pre-Dose 1 | 8 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:28 Days PD2 | 108 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:7 Days PD2 | 108 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:28 Days PD1 | 143 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run: Pre-Dose 1 | 9 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:28 Days PD1 | 116 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:21 Days PD1 | 120 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:7 Days PD2 | 134 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:7 Days PD1 | 140 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run: Pre-Dose 1 | 21 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:28 Days PD2 | 115 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: II Run:365 Days PD2 | 23 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: II Run:365 Days PD2 | 11 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: II Run:28 Days PD2 | 15 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: II Run:365 Days PD2 | 13 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:7 Days PD2 | 112 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: II Run:Pre-Dose 1 | 3 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:28 Days PD1 | 106 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run: Pre-Dose 1 | 13 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: II Run:152 Days PD2 | 13 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run: Pre-Dose 1 | 5 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:7 Days PD1 | 357 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:28 Days PD1 | 68 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:28 Days PD2 | 80 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: II Run:152 Days PD2 | 20 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:7 Days PD1 | 193 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:7 Days PD2 | 94 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: II Run:28 Days PD2 | 32 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:21 Days PD1 | 113 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:28 Days PD2 | 76 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: II Run:Pre-Dose 1 | 4 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:21 Days PD1 | 164 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run: Pre-Dose 1 | 5 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:21 Days PD1 | 269 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:28 Days PD2 | 19 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: II Run:152 Days PD2 | 10 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:7 Days PD2 | 17 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: II Run:365 Days PD2 | 8 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:28 Days PD1 | 183 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:28 Days PD1 | 19 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:21 Days PD1 | 27 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:28 Days PD2 | 70 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:7 Days PD1 | 57 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: II Run:Pre-Dose 1 | 3 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:7 Days PD2 | 130 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: II Run:152 Days PD2 | 9 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: II Run:365 Days PD2 | 8 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:7 Days PD1 | 458 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run: Pre-Dose 1 | 5 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: II Run:28 Days PD2 | 17 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: II Run:28 Days PD2 | 11 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: II Run:Pre-Dose 1 | 4 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run: Pre-Dose 1 | 6 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:7 Days PD1 | 675 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:21 Days PD1 | 307 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:28 Days PD1 | 149 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:7 Days PD2 | 131 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:28 Days PD2 | 78 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: II Run:Pre-Dose 1 | 3 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: II Run:28 Days PD2 | 16 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: II Run:152 Days PD2 | 16 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: II Run:365 Days PD2 | 14 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run: Pre-Dose 1 | 9 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:7 Days PD1 | 52 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:21 Days PD1 | 25 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:28 Days PD1 | 19 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:7 Days PD2 | 22 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:28 Days PD2 | 19 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: II Run:Pre-Dose 1 | 8 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: II Run:28 Days PD2 | 19 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: II Run:152 Days PD2 | 14 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: II Run:365 Days PD2 | 16 titer |
| Cohort A1-A4: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: II Run:28 Days PD2 | 6 titer |
| Cohort A1-A4: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:28 Days PD1 | 9 titer |
| Cohort A1-A4: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:28 Days PD1 | 19 titer |
| Cohort A1-A4: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:7 Days PD2 | 29 titer |
| Cohort A1-A4: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: II Run:Pre-Dose 1 | 6 titer |
| Cohort A1-A4: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:28 Days PD2 | 10 titer |
| Cohort A1-A4: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run: Pre-Dose 1 | 10 titer |
| Cohort A1-A4: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: II Run:365 Days PD2 | 5 titer |
| Cohort A1-A4: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: II Run:152 Days PD2 | 6 titer |
| Cohort A1-A4: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:7 Days PD1 | 7 titer |
| Cohort A1-A4: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: II Run:365 Days PD2 | 6 titer |
| Cohort A1-A4: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run: Pre-Dose 1 | 23 titer |
| Cohort A1-A4: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: II Run:28 Days PD2 | 7 titer |
| Cohort A1-A4: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:7 Days PD2 | 11 titer |
| Cohort A1-A4: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:7 Days PD1 | 18 titer |
| Cohort A1-A4: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: II Run:Pre-Dose 1 | 5 titer |
| Cohort A1-A4: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:21 Days PD1 | 9 titer |
| Cohort A1-A4: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: II Run:152 Days PD2 | 6 titer |
| Cohort A1-A4: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:21 Days PD1 | 16 titer |
| Cohort A1-A4: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:28 Days PD2 | 30 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: II Run:Pre-Dose 1 | 9 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:28 Days PD1 | 178 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: II Run:365 Days PD2 | 17 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: II Run:152 Days PD2 | 57 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:21 Days PD1 | 63 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:28 Days PD1 | 42 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run: Pre-Dose 1 | 3 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run: Pre-Dose 1 | 9 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:21 Days PD1 | 252 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: II Run:365 Days PD2 | 38 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:28 Days PD2 | 97 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:7 Days PD2 | 44 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:7 Days PD1 | 92 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: II Run:Pre-Dose 1 | 3 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:7 Days PD1 | 357 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: II Run:28 Days PD2 | 38 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: II Run:28 Days PD2 | 120 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:7 Days PD2 | 140 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: II Run:152 Days PD2 | 27 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:28 Days PD2 | 34 titer |
| Cohort B: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:7 Days PD1 | 5 titer |
| Cohort B: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: II Run:365 Days PD2 | 6 titer |
| Cohort B: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:21 Days PD1 | 5 titer |
| Cohort B: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:28 Days PD2 | 5 titer |
| Cohort B: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:7 Days PD2 | 5 titer |
| Cohort B: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:28 Days PD2 | 5 titer |
| Cohort B: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run: Pre-Dose 1 | 5 titer |
| Cohort B: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: II Run:28 Days PD2 | 5 titer |
| Cohort B: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: II Run:365 Days PD2 | 7 titer |
| Cohort B: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run: Pre-Dose 1 | 5 titer |
| Cohort B: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: II Run:152 Days PD2 | 6 titer |
| Cohort B: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:28 Days PD1 | 5 titer |
| Cohort B: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: II Run:Pre-Dose 1 | 6 titer |
| Cohort B: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:21 Days PD1 | 5 titer |
| Cohort B: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:7 Days PD2 | 5 titer |
| Cohort B: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:7 Days PD1 | 5 titer |
| Cohort B: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: II Run:28 Days PD2 | 6 titer |
| Cohort B: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:28 Days PD1 | 5 titer |
| Cohort B: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: II Run:152 Days PD2 | 6 titer |
| Cohort B: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: II Run:Pre-Dose 1 | 5 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: II Run:152 Days PD2 | 29 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: II Run:28 Days PD2 | 154 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:28 Days PD2 | 76 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run: Pre-Dose 1 | 5 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: II Run:152 Days PD2 | 78 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: II Run:365 Days PD2 | 53 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:7 Days PD2 | 105 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run: Pre-Dose 1 | 9 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:7 Days PD1 | 41 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:28 Days PD1 | 104 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:21 Days PD1 | 25 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: II Run:365 Days PD2 | 24 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:28 Days PD1 | 22 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:7 Days PD2 | 22 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:21 Days PD1 | 114 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:28 Days PD2 | 21 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: II Run:Pre-Dose 1 | 18 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:7 Days PD1 | 208 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: II Run:28 Days PD2 | 44 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: II Run:Pre-Dose 1 | 6 titer |
| Cohort C: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:28 Days PD2 | 4 titer |
| Cohort C: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: II Run:Pre-Dose 1 | 8 titer |
| Cohort C: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:28 Days PD1 | 6 titer |
| Cohort C: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: II Run:365 Days PD2 | 7 titer |
| Cohort C: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:7 Days PD1 | 4 titer |
| Cohort C: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run: Pre-Dose 1 | 4 titer |
| Cohort C: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:7 Days PD1 | 7 titer |
| Cohort C: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:7 Days PD2 | 4 titer |
| Cohort C: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: II Run:28 Days PD2 | 8 titer |
| Cohort C: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:28 Days PD2 | 6 titer |
| Cohort C: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run: Pre-Dose 1 | 6 titer |
| Cohort C: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: II Run:365 Days PD2 | 11 titer |
| Cohort C: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: II Run:Pre-Dose 1 | 5 titer |
| Cohort C: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:28 Days PD1 | 4 titer |
| Cohort C: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: II Run:28 Days PD2 | 5 titer |
| Cohort C: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:21 Days PD1 | 4 titer |
| Cohort C: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: II Run:152 Days PD2 | 6 titer |
| Cohort C: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:7 Days PD2 | 7 titer |
| Cohort C: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: II Run:152 Days PD2 | 9 titer |
| Cohort C: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:21 Days PD1 | 7 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:7 Days PD2 | 36 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:28 Days PD1 | 39 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: II Run:365 Days PD2 | 19 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:21 Days PD1 | 55 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:28 Days PD2 | 17 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:28 Days PD2 | 31 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:7 Days PD1 | 40 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:28 Days PD1 | 21 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:7 Days PD1 | 96 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: II Run:Pre-Dose 1 | 5 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run: Pre-Dose 1 | 5 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: II Run:28 Days PD2 | 35 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: II Run:28 Days PD2 | 42 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: II Run:365 Days PD2 | 16 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:7 Days PD2 | 19 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: II Run:152 Days PD2 | 25 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run: Pre-Dose 1 | 3 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: II Run:152 Days PD2 | 24 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: II Run:Pre-Dose 1 | 4 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:21 Days PD1 | 31 titer |
| Cohort D: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:28 Days PD2 | 3 titer |
| Cohort D: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:7 Days PD2 | 3 titer |
| Cohort D: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: II Run:152 Days PD2 | 3 titer |
| Cohort D: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:7 Days PD1 | 6 titer |
| Cohort D: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:7 Days PD2 | 6 titer |
| Cohort D: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: II Run:152 Days PD2 | 6 titer |
| Cohort D: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:21 Days PD1 | 3 titer |
| Cohort D: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:28 Days PD1 | 6 titer |
| Cohort D: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: II Run:365 Days PD2 | 6 titer |
| Cohort D: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: II Run:28 Days PD2 | 3 titer |
| Cohort D: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:7 Days PD1 | 3 titer |
| Cohort D: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:28 Days PD2 | 6 titer |
| Cohort D: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run: Pre-Dose 1 | 6 titer |
| Cohort D: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: II Run:Pre-Dose 1 | 3 titer |
| Cohort D: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: II Run:28 Days PD2 | 7 titer |
| Cohort D: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run:28 Days PD1 | 3 titer |
| Cohort D: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: II Run:365 Days PD2 | 3 titer |
| Cohort D: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GI.1: I Run: Pre-Dose 1 | 3 titer |
| Cohort D: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: I Run:21 Days PD1 | 6 titer |
| Cohort D: Placebo | Geometric Mean Titer (GMT) of Serum Anti-norovirus GI.1 and GII.4 VLP Ig (Immunoglobulin) A | GII.4: II Run:Pre-Dose 1 | 7 titer |
Secondary
GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline
GMFRs in GMTs of Anti-norovirus GI.1 and GII.4 VLP by Pan-Ig ELISA. A pan ELISA assay captured IgG, IgA and IgM combined. Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
Time frame: I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)
Population: PP population where baseline and specified post-baseline assessment were available. PP population included all participants who received both doses of study product and with no protocol deviations likely to affect the immunogenicity assessment.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:28 Days PD2 | 54.9 fold rise |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:21 Days PD1 | 69.1 fold rise |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:28 Days PD1 | 5.9 fold rise |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: II Run:152 Days PD2 | 3.7 fold rise |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:7 Days PD1 | 4.7 fold rise |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:7 Days PD2 | 47 fold rise |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: II Run:28 Days PD2 | 6.3 fold rise |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: II Run:365 Days PD2 | 25.4 fold rise |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:7 Days PD2 | 6.3 fold rise |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:21 Days PD1 | 5.9 fold rise |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: II Run:152 Days PD2 | 17.4 fold rise |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:7 Days PD1 | 43.5 fold rise |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:28 Days PD1 | 59.3 fold rise |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: II Run:365 Days PD2 | 4 fold rise |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:28 Days PD2 | 6.3 fold rise |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: II Run:28 Days PD2 | 59.3 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: II Run:28 Days PD2 | 78 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:28 Days PD2 | 70.7 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:7 Days PD2 | 78 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: II Run:28 Days PD2 | 8.8 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:7 Days PD2 | 10.8 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:28 Days PD1 | 10.4 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: II Run:152 Days PD2 | 4.9 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:21 Days PD1 | 11.3 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:7 Days PD1 | 13.5 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:21 Days PD1 | 83 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:28 Days PD2 | 10.8 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: II Run:365 Days PD2 | 4.9 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: II Run:365 Days PD2 | 21.5 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:7 Days PD1 | 98.7 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: II Run:152 Days PD2 | 39 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:28 Days PD1 | 53.8 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:7 Days PD2 | 29.9 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: II Run:28 Days PD2 | 23.5 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: II Run:152 Days PD2 | 6.3 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:21 Days PD1 | 111.4 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:28 Days PD1 | 84.4 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:7 Days PD2 | 104 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:28 Days PD2 | 64 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: II Run:28 Days PD2 | 64 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: II Run:152 Days PD2 | 27.4 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: II Run:365 Days PD2 | 3.4 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: II Run:365 Days PD2 | 19 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:7 Days PD1 | 137.2 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:7 Days PD1 | 48.5 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:21 Days PD1 | 34.3 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:28 Days PD1 | 26 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:28 Days PD2 | 21.8 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: II Run:152 Days PD2 | 3.4 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:7 Days PD2 | 98.7 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:7 Days PD1 | 128 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: II Run:365 Days PD2 | 3.3 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: II Run:28 Days PD2 | 6.7 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: II Run:365 Days PD2 | 58 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:21 Days PD1 | 17.4 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: II Run:152 Days PD2 | 64 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:28 Days PD1 | 9.5 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:28 Days PD2 | 69.8 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:28 Days PD1 | 90.5 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:28 Days PD2 | 7.3 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: II Run:28 Days PD2 | 107.6 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:7 Days PD1 | 19.5 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:21 Days PD1 | 98.7 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:7 Days PD2 | 10.4 fold rise |
| Cohort A1-A4: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: II Run:365 Days PD2 | 1 fold rise |
| Cohort A1-A4: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: II Run:152 Days PD2 | 1.5 fold rise |
| Cohort A1-A4: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:21 Days PD1 | 1.1 fold rise |
| Cohort A1-A4: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: II Run:365 Days PD2 | 1.2 fold rise |
| Cohort A1-A4: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:28 Days PD1 | 1.2 fold rise |
| Cohort A1-A4: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: II Run:28 Days PD2 | 1.1 fold rise |
| Cohort A1-A4: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:7 Days PD2 | 1.4 fold rise |
| Cohort A1-A4: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: II Run:28 Days PD2 | 2 fold rise |
| Cohort A1-A4: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:28 Days PD2 | 2 fold rise |
| Cohort A1-A4: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: II Run:152 Days PD2 | 1 fold rise |
| Cohort A1-A4: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:7 Days PD2 | 1.8 fold rise |
| Cohort A1-A4: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:28 Days PD2 | 1.4 fold rise |
| Cohort A1-A4: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:7 Days PD1 | 1 fold rise |
| Cohort A1-A4: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:21 Days PD1 | 1.1 fold rise |
| Cohort A1-A4: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:28 Days PD1 | 1.4 fold rise |
| Cohort A1-A4: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:7 Days PD1 | 1 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:21 Days PD1 | 117.4 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:28 Days PD2 | 166 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: II Run:28 Days PD2 | 38.1 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:7 Days PD2 | 128 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: II Run:365 Days PD2 | 29.3 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: II Run:365 Days PD2 | 14.7 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:28 Days PD1 | 117.4 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:21 Days PD1 | 34.9 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:28 Days PD1 | 32 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: II Run:152 Days PD2 | 38.1 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: II Run:152 Days PD2 | 58.7 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:7 Days PD1 | 83 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:7 Days PD2 | 34.9 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: II Run:28 Days PD2 | 139.6 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:28 Days PD2 | 26.9 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:7 Days PD1 | 24.7 fold rise |
| Cohort B: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: II Run:152 Days PD2 | 1.1 fold rise |
| Cohort B: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: II Run:28 Days PD2 | 0.9 fold rise |
| Cohort B: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:28 Days PD2 | 0.8 fold rise |
| Cohort B: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: II Run:152 Days PD2 | 1 fold rise |
| Cohort B: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:21 Days PD1 | 0.9 fold rise |
| Cohort B: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:28 Days PD2 | 0.8 fold rise |
| Cohort B: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: II Run:365 Days PD2 | 1 fold rise |
| Cohort B: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:7 Days PD1 | 0.9 fold rise |
| Cohort B: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:7 Days PD1 | 0.8 fold rise |
| Cohort B: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:21 Days PD1 | 0.8 fold rise |
| Cohort B: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:28 Days PD1 | 0.9 fold rise |
| Cohort B: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:28 Days PD1 | 0.9 fold rise |
| Cohort B: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: II Run:28 Days PD2 | 1 fold rise |
| Cohort B: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: II Run:365 Days PD2 | 1.3 fold rise |
| Cohort B: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:7 Days PD2 | 0.8 fold rise |
| Cohort B: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:7 Days PD2 | 0.8 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:28 Days PD1 | 11.8 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:7 Days PD2 | 13.7 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: II Run:152 Days PD2 | 18.7 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:7 Days PD1 | 9.3 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:28 Days PD2 | 10.9 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: II Run:152 Days PD2 | 4.7 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:28 Days PD2 | 27.4 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: II Run:365 Days PD2 | 3.7 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:7 Days PD1 | 23.5 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: II Run:28 Days PD2 | 8.6 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:28 Days PD1 | 18.7 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: II Run:28 Days PD2 | 32 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:21 Days PD1 | 19 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:7 Days PD2 | 27.4 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: II Run:365 Days PD2 | 10.9 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:21 Days PD1 | 20.7 fold rise |
| Cohort C: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: II Run:152 Days PD2 | 1.3 fold rise |
| Cohort C: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:28 Days PD2 | 0.9 fold rise |
| Cohort C: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: II Run:365 Days PD2 | 1.9 fold rise |
| Cohort C: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:28 Days PD2 | 1.4 fold rise |
| Cohort C: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:28 Days PD1 | 0.9 fold rise |
| Cohort C: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: II Run:365 Days PD2 | 1.4 fold rise |
| Cohort C: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: II Run:28 Days PD2 | 1 fold rise |
| Cohort C: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: II Run:152 Days PD2 | 0.9 fold rise |
| Cohort C: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:28 Days PD1 | 1 fold rise |
| Cohort C: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:21 Days PD1 | 1 fold rise |
| Cohort C: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:7 Days PD2 | 1.2 fold rise |
| Cohort C: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: II Run:28 Days PD2 | 0.9 fold rise |
| Cohort C: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:7 Days PD1 | 1 fold rise |
| Cohort C: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:21 Days PD1 | 0.8 fold rise |
| Cohort C: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:7 Days PD2 | 1 fold rise |
| Cohort C: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:7 Days PD1 | 0.8 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:21 Days PD1 | 34.9 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:7 Days PD1 | 98.7 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:21 Days PD1 | 107.6 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:28 Days PD1 | 83 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:7 Days PD2 | 98.7 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:28 Days PD2 | 69.8 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: II Run:28 Days PD2 | 152.2 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: II Run:152 Days PD2 | 53.8 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: II Run:365 Days PD2 | 43.1 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:7 Days PD1 | 49.4 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:28 Days PD1 | 20.7 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:7 Days PD2 | 29.3 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:28 Days PD2 | 19 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: II Run:28 Days PD2 | 22.6 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: II Run:152 Days PD2 | 9.5 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: II Run:365 Days PD2 | 8.8 fold rise |
| Cohort D: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:7 Days PD2 | 1.1 fold rise |
| Cohort D: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:28 Days PD1 | 0.8 fold rise |
| Cohort D: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:21 Days PD1 | 0.9 fold rise |
| Cohort D: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: II Run:365 Days PD2 | 1 fold rise |
| Cohort D: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: II Run:152 Days PD2 | 1 fold rise |
| Cohort D: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:7 Days PD1 | 0.8 fold rise |
| Cohort D: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: II Run:365 Days PD2 | 0.9 fold rise |
| Cohort D: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: II Run:152 Days PD2 | 1 fold rise |
| Cohort D: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: II Run:28 Days PD2 | 0.9 fold rise |
| Cohort D: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:28 Days PD2 | 1 fold rise |
| Cohort D: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:7 Days PD2 | 1 fold rise |
| Cohort D: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:28 Days PD1 | 0.8 fold rise |
| Cohort D: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:21 Days PD1 | 1 fold rise |
| Cohort D: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GI.1: I Run:7 Days PD1 | 1 fold rise |
| Cohort D: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: II Run:28 Days PD2 | 1.1 fold rise |
| Cohort D: Placebo | GMFR of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA as Compared to Baseline | GII.4: I Run:28 Days PD2 | 1.1 fold rise |
Secondary
GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline
Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
Time frame: I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)
Population: PP population where baseline and specified post-baseline assessment were available. PP population included all participants who received both doses of study product and with no protocol deviations likely to affect the immunogenicity assessment.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:7 Days PD2 | 21.6 fold rise |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:7 Days PD1 | 16.2 fold rise |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:21 Days PD1 | 3.8 fold rise |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:21 Days PD1 | 20.5 fold rise |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:28 Days PD2 | 4.6 fold rise |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: II Run:365 Days PD2 | 9.3 fold rise |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: II Run:28 Days PD2 | 17 fold rise |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:28 Days PD1 | 20 fold rise |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: II Run:365 Days PD2 | 2.7 fold rise |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:7 Days PD1 | 2.6 fold rise |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:28 Days PD1 | 3.7 fold rise |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:7 Days PD2 | 3.8 fold rise |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: II Run:28 Days PD2 | 5 fold rise |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:28 Days PD2 | 22 fold rise |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: II Run:152 Days PD2 | 3.1 fold rise |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: II Run:152 Days PD2 | 7.9 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:7 Days PD2 | 23.8 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:21 Days PD1 | 22.8 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:7 Days PD1 | 7.1 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:28 Days PD2 | 4.6 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: II Run:28 Days PD2 | 14.1 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: II Run:152 Days PD2 | 4 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: II Run:365 Days PD2 | 7.9 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:7 Days PD2 | 4.8 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:28 Days PD1 | 18.9 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: II Run:365 Days PD2 | 4.6 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:21 Days PD1 | 6.6 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: II Run:28 Days PD2 | 6.8 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: II Run:152 Days PD2 | 9.8 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:28 Days PD1 | 5.1 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:7 Days PD1 | 29.4 fold rise |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:28 Days PD2 | 23.1 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:28 Days PD2 | 5.8 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:28 Days PD1 | 6 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:21 Days PD1 | 42 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:7 Days PD1 | 8.3 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:7 Days PD2 | 26.1 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:21 Days PD1 | 6.8 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:28 Days PD2 | 19.7 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: II Run:365 Days PD2 | 2.4 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: II Run:28 Days PD2 | 18.8 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:28 Days PD1 | 32.8 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: II Run:365 Days PD2 | 6.1 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:7 Days PD2 | 6.6 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: II Run:152 Days PD2 | 3.9 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: II Run:152 Days PD2 | 9.6 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:7 Days PD1 | 59.5 fold rise |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: II Run:28 Days PD2 | 12 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:28 Days PD1 | 2.2 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:21 Days PD1 | 2.3 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:21 Days PD1 | 55.2 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:28 Days PD1 | 39.2 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: II Run:28 Days PD2 | 3.5 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:7 Days PD2 | 42.8 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: II Run:152 Days PD2 | 1.7 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:28 Days PD2 | 32.9 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:28 Days PD2 | 2.4 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: II Run:28 Days PD2 | 23.9 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:7 Days PD1 | 54.9 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: II Run:152 Days PD2 | 15.5 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:7 Days PD2 | 2.5 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: II Run:365 Days PD2 | 11.7 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:7 Days PD1 | 2.4 fold rise |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: II Run:365 Days PD2 | 1.9 fold rise |
| Cohort A1-A4: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: II Run:365 Days PD2 | 1.3 fold rise |
| Cohort A1-A4: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: II Run:365 Days PD2 | 1.1 fold rise |
| Cohort A1-A4: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: II Run:152 Days PD2 | 1.1 fold rise |
| Cohort A1-A4: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:21 Days PD1 | 0.9 fold rise |
| Cohort A1-A4: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:7 Days PD2 | 1.2 fold rise |
| Cohort A1-A4: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:7 Days PD1 | 1 fold rise |
| Cohort A1-A4: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:28 Days PD1 | 1.1 fold rise |
| Cohort A1-A4: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:28 Days PD1 | 1 fold rise |
| Cohort A1-A4: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:28 Days PD2 | 1.2 fold rise |
| Cohort A1-A4: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:7 Days PD1 | 0.7 fold rise |
| Cohort A1-A4: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: II Run:28 Days PD2 | 1.6 fold rise |
| Cohort A1-A4: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: II Run:28 Days PD2 | 1.4 fold rise |
| Cohort A1-A4: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: II Run:152 Days PD2 | 1.4 fold rise |
| Cohort A1-A4: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:28 Days PD2 | 1.5 fold rise |
| Cohort A1-A4: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:21 Days PD1 | 1 fold rise |
| Cohort A1-A4: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:7 Days PD2 | 1.4 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:7 Days PD2 | 12.3 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:7 Days PD2 | 59 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: II Run:152 Days PD2 | 15.9 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:28 Days PD1 | 49.3 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: II Run:28 Days PD2 | 18.1 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:7 Days PD1 | 6.8 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: II Run:365 Days PD2 | 8.9 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:21 Days PD1 | 52.5 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: II Run:152 Days PD2 | 13.4 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:28 Days PD1 | 10.8 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:7 Days PD1 | 43 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: II Run:365 Days PD2 | 7.7 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:28 Days PD2 | 59.5 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:21 Days PD1 | 11.7 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: II Run:28 Days PD2 | 32 fold rise |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:28 Days PD2 | 12.8 fold rise |
| Cohort B: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: II Run:152 Days PD2 | 1.2 fold rise |
| Cohort B: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: II Run:365 Days PD2 | 1.4 fold rise |
| Cohort B: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:28 Days PD1 | 0.8 fold rise |
| Cohort B: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:7 Days PD2 | 1 fold rise |
| Cohort B: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:28 Days PD2 | 0.9 fold rise |
| Cohort B: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: II Run:28 Days PD2 | 0.8 fold rise |
| Cohort B: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: II Run:152 Days PD2 | 1 fold rise |
| Cohort B: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: II Run:365 Days PD2 | 0.9 fold rise |
| Cohort B: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:7 Days PD1 | 1 fold rise |
| Cohort B: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:7 Days PD1 | 0.9 fold rise |
| Cohort B: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:21 Days PD1 | 1 fold rise |
| Cohort B: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:28 Days PD1 | 0.9 fold rise |
| Cohort B: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:7 Days PD2 | 1 fold rise |
| Cohort B: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:28 Days PD2 | 1.1 fold rise |
| Cohort B: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:21 Days PD1 | 0.8 fold rise |
| Cohort B: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: II Run:28 Days PD2 | 1.3 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:7 Days PD2 | 11.3 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:28 Days PD1 | 7.9 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: II Run:152 Days PD2 | 8.7 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: II Run:152 Days PD2 | 3.6 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: II Run:28 Days PD2 | 5.7 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:21 Days PD1 | 7.5 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: II Run:365 Days PD2 | 2.5 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:7 Days PD1 | 6.8 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:21 Days PD1 | 3.3 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:7 Days PD2 | 3.4 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:28 Days PD1 | 3 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: II Run:28 Days PD2 | 10.9 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:7 Days PD1 | 2.3 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:28 Days PD2 | 12.6 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: II Run:365 Days PD2 | 6 fold rise |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:28 Days PD2 | 3.7 fold rise |
| Cohort C: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:7 Days PD2 | 0.9 fold rise |
| Cohort C: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:28 Days PD1 | 0.9 fold rise |
| Cohort C: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:7 Days PD2 | 1.2 fold rise |
| Cohort C: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: II Run:152 Days PD2 | 1.2 fold rise |
| Cohort C: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:21 Days PD1 | 0.9 fold rise |
| Cohort C: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:28 Days PD1 | 1 fold rise |
| Cohort C: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: II Run:152 Days PD2 | 1 fold rise |
| Cohort C: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: II Run:28 Days PD2 | 1 fold rise |
| Cohort C: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: II Run:365 Days PD2 | 1.9 fold rise |
| Cohort C: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:28 Days PD2 | 1.1 fold rise |
| Cohort C: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: II Run:28 Days PD2 | 1 fold rise |
| Cohort C: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:21 Days PD1 | 1.3 fold rise |
| Cohort C: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:28 Days PD2 | 0.9 fold rise |
| Cohort C: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: II Run:365 Days PD2 | 1.3 fold rise |
| Cohort C: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:7 Days PD1 | 0.9 fold rise |
| Cohort C: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:7 Days PD1 | 1.4 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:7 Days PD1 | 16.1 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: II Run:365 Days PD2 | 8.2 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:28 Days PD1 | 13.4 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: II Run:152 Days PD2 | 11.5 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: II Run:28 Days PD2 | 26.6 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:7 Days PD2 | 13.1 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:7 Days PD1 | 11.2 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:28 Days PD2 | 17.2 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:7 Days PD2 | 14.7 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: II Run:152 Days PD2 | 6.5 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:28 Days PD2 | 12.7 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:28 Days PD1 | 12.7 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:21 Days PD1 | 14.4 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: II Run:28 Days PD2 | 12.2 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: II Run:365 Days PD2 | 6 fold rise |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:21 Days PD1 | 16.4 fold rise |
| Cohort D: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: II Run:365 Days PD2 | 0.9 fold rise |
| Cohort D: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:7 Days PD1 | 1 fold rise |
| Cohort D: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:21 Days PD1 | 1 fold rise |
| Cohort D: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:28 Days PD1 | 1.1 fold rise |
| Cohort D: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:7 Days PD2 | 1 fold rise |
| Cohort D: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: I Run:28 Days PD2 | 1.1 fold rise |
| Cohort D: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: II Run:28 Days PD2 | 1.1 fold rise |
| Cohort D: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: II Run:152 Days PD2 | 0.9 fold rise |
| Cohort D: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GI.1: II Run:365 Days PD2 | 1 fold rise |
| Cohort D: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:7 Days PD1 | 1.3 fold rise |
| Cohort D: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:21 Days PD1 | 1.4 fold rise |
| Cohort D: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:28 Days PD1 | 1.3 fold rise |
| Cohort D: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:7 Days PD2 | 1.2 fold rise |
| Cohort D: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: I Run:28 Days PD2 | 1.3 fold rise |
| Cohort D: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: II Run:28 Days PD2 | 1 fold rise |
| Cohort D: Placebo | GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgG as Compared to Baseline | GII.4: II Run:152 Days PD2 | 0.9 fold rise |
Secondary
GMFR of Serum Anti-norovirus GI.1 and GII.4 VLP IgM as Compared to Baseline
Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
Time frame: I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)
Population: Data was not collected because serum specimens were not tested for specific IgM antibodies to Norovirus GI.1 and GII.4 VLPs as per the change in planned analysis, because this measurement was not informative in a previous study LV01-103 (NCT00973284).
Secondary
GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA)
GMTs were assessed for Anti-norovirus GI.1 and GII.4 VLP by Pan-Ig ELISA. A pan ELISA assay captured IgG, IgA and IgM combined. Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
Time frame: I run: predose 1, 7, 21, 28 days PD1, 7 and 28 days PD2; II run: predose 1, 28, 152 and 365 days PD2 (up to Day 393)
Population: PP population included all participants who received both doses of study product and with no protocol deviations likely to affect the immunogenicity assessment.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:28 Days PD1 | 70225 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: II Run:152 Days PD2 | 81920 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:7 Days PD2 | 176957 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:21 Days PD1 | 260080 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: II Run:365 Days PD2 | 145965 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: II Run:Pre-Dose 1 | 13934 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:28 Days PD1 | 222952 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: II Run:28 Days PD2 | 88478 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:7 Days PD1 | 55738 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run: Pre-Dose 1 | 11945 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: II Run:152 Days PD2 | 97420 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: II Run:365 Days PD2 | 45976 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:7 Days PD1 | 163840 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:21 Days PD1 | 70225 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: II Run:Pre-Dose 1 | 4389 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:7 Days PD2 | 75848 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run: Pre-Dose 1 | 3763 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: II Run:28 Days PD2 | 260080 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:28 Days PD2 | 206425 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:28 Days PD2 | 75848 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:28 Days PD1 | 40960 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: II Run:365 Days PD2 | 67202 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run: Pre-Dose 1 | 3948 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: II Run:365 Days PD2 | 49931 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:7 Days PD1 | 231705 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run: Pre-Dose 1 | 2348 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: II Run:152 Days PD2 | 49931 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:21 Days PD1 | 194840 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: II Run:28 Days PD2 | 90447 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:28 Days PD1 | 126338 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: II Run:Pre-Dose 1 | 10240 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:7 Days PD2 | 163840 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:28 Days PD2 | 60866 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:28 Days PD2 | 148394 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:7 Days PD2 | 60866 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: II Run:Pre-Dose 1 | 3121 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: II Run:28 Days PD2 | 243465 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:21 Days PD1 | 44667 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: II Run:152 Days PD2 | 121733 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:7 Days PD1 | 53119 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run: Pre-Dose 1 | 1470 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:28 Days PD1 | 38217 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: II Run:28 Days PD2 | 103213 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:7 Days PD2 | 43900 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: II Run:152 Days PD2 | 95562 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:7 Days PD2 | 266159 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: II Run:Pre-Dose 1 | 3484 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:7 Days PD1 | 351199 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: II Run:Pre-Dose 1 | 4389 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run: Pre-Dose 1 | 2560 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:21 Days PD1 | 50428 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: II Run:365 Days PD2 | 63169 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:28 Days PD2 | 47781 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:21 Days PD1 | 285262 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: II Run:152 Days PD2 | 27869 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: II Run:28 Days PD2 | 222952 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:7 Days PD1 | 71316 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: II Run:365 Days PD2 | 20480 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:28 Days PD2 | 176957 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:28 Days PD1 | 216188 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run: Pre-Dose 1 | 2153 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:7 Days PD2 | 212474 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:28 Days PD2 | 212474 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: II Run:152 Days PD2 | 126338 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:28 Days PD2 | 150242 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:7 Days PD2 | 300484 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: II Run:365 Days PD2 | 67202 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:7 Days PD1 | 220512 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:7 Days PD1 | 593575 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: II Run:Pre-Dose 1 | 1974 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:28 Days PD1 | 275545 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run: Pre-Dose 1 | 28963 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: II Run:28 Days PD2 | 212474 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: II Run:152 Days PD2 | 63169 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:21 Days PD1 | 505352 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: II Run:28 Days PD2 | 126338 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:21 Days PD1 | 212474 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: II Run:365 Days PD2 | 81920 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:28 Days PD1 | 194840 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: II Run:Pre-Dose 1 | 18780 titer |
| Cohort A1-A4: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:7 Days PD2 | 10240 titer |
| Cohort A1-A4: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:21 Days PD1 | 1185 titer |
| Cohort A1-A4: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: II Run:28 Days PD2 | 3446 titer |
| Cohort A1-A4: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: II Run:Pre-Dose 1 | 4200 titer |
| Cohort A1-A4: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:28 Days PD2 | 11167 titer |
| Cohort A1-A4: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run: Pre-Dose 1 | 1396 titer |
| Cohort A1-A4: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run: Pre-Dose 1 | 5583 titer |
| Cohort A1-A4: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: II Run:365 Days PD2 | 2153 titer |
| Cohort A1-A4: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:7 Days PD2 | 1974 titer |
| Cohort A1-A4: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:28 Days PD1 | 6451 titer |
| Cohort A1-A4: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:28 Days PD1 | 1280 titer |
| Cohort A1-A4: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: II Run:Pre-Dose 1 | 3121 titer |
| Cohort A1-A4: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: II Run:365 Days PD2 | 3948 titer |
| Cohort A1-A4: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: II Run:28 Days PD2 | 8400 titer |
| Cohort A1-A4: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:7 Days PD1 | 1185 titer |
| Cohort A1-A4: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:28 Days PD2 | 1974 titer |
| Cohort A1-A4: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:7 Days PD1 | 4740 titer |
| Cohort A1-A4: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:21 Days PD1 | 5120 titer |
| Cohort A1-A4: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: II Run:152 Days PD2 | 3121 titer |
| Cohort A1-A4: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: II Run:152 Days PD2 | 6241 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: II Run:28 Days PD2 | 357338 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run: Pre-Dose 1 | 1810 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:7 Days PD1 | 150242 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:21 Days PD1 | 212474 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:28 Days PD1 | 212474 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:7 Days PD2 | 231705 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:28 Days PD2 | 300484 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: II Run:Pre-Dose 1 | 2560 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: II Run:152 Days PD2 | 150242 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: II Run:365 Days PD2 | 75121 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run: Pre-Dose 1 | 4695 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:7 Days PD1 | 115852 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:21 Days PD1 | 163840 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:28 Days PD1 | 150242 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:7 Days PD2 | 163840 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:28 Days PD2 | 126338 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: II Run:Pre-Dose 1 | 3948 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: II Run:28 Days PD2 | 150242 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: II Run:152 Days PD2 | 150242 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: II Run:365 Days PD2 | 57926 titer |
| Cohort B: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:28 Days PD2 | 1810 titer |
| Cohort B: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: II Run:152 Days PD2 | 2941 titer |
| Cohort B: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: II Run:152 Days PD2 | 2744 titer |
| Cohort B: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:7 Days PD2 | 2229 titer |
| Cohort B: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: II Run:28 Days PD2 | 2560 titer |
| Cohort B: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: II Run:365 Days PD2 | 2941 titer |
| Cohort B: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: II Run:365 Days PD2 | 3378 titer |
| Cohort B: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: II Run:Pre-Dose 1 | 2941 titer |
| Cohort B: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:21 Days PD1 | 2389 titer |
| Cohort B: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run: Pre-Dose 1 | 2744 titer |
| Cohort B: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:28 Days PD1 | 2079 titer |
| Cohort B: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: II Run:28 Days PD2 | 2744 titer |
| Cohort B: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run: Pre-Dose 1 | 2229 titer |
| Cohort B: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:7 Days PD1 | 2229 titer |
| Cohort B: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:7 Days PD2 | 1810 titer |
| Cohort B: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: II Run:Pre-Dose 1 | 2560 titer |
| Cohort B: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:7 Days PD1 | 1940 titer |
| Cohort B: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:21 Days PD1 | 1810 titer |
| Cohort B: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:28 Days PD2 | 2079 titer |
| Cohort B: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:28 Days PD1 | 2389 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: II Run:365 Days PD2 | 27869 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:7 Days PD2 | 130040 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:7 Days PD1 | 88478 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:28 Days PD1 | 120401 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:28 Days PD2 | 103213 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run: Pre-Dose 1 | 9481 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:7 Days PD2 | 176957 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: II Run:365 Days PD2 | 47781 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: II Run:152 Days PD2 | 35113 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: II Run:152 Days PD2 | 81920 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: II Run:28 Days PD2 | 140451 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run: Pre-Dose 1 | 6451 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:21 Days PD1 | 126338 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:7 Days PD1 | 151695 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: II Run:28 Days PD2 | 65020 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: II Run:Pre-Dose 1 | 4389 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:28 Days PD1 | 111476 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:21 Days PD1 | 115852 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: II Run:Pre-Dose 1 | 7525 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:28 Days PD2 | 176957 titer |
| Cohort C: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run: Pre-Dose 1 | 8127 titer |
| Cohort C: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: II Run:152 Days PD2 | 2370 titer |
| Cohort C: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run: Pre-Dose 1 | 2763 titer |
| Cohort C: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:7 Days PD1 | 6451 titer |
| Cohort C: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: II Run:28 Days PD2 | 2195 titer |
| Cohort C: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:21 Days PD1 | 9390 titer |
| Cohort C: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: II Run:Pre-Dose 1 | 2560 titer |
| Cohort C: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:28 Days PD1 | 7525 titer |
| Cohort C: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:28 Days PD2 | 5120 titer |
| Cohort C: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:7 Days PD2 | 8127 titer |
| Cohort C: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:7 Days PD2 | 4389 titer |
| Cohort C: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:28 Days PD2 | 6967 titer |
| Cohort C: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:28 Days PD1 | 3763 titer |
| Cohort C: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: II Run:Pre-Dose 1 | 6967 titer |
| Cohort C: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:21 Days PD1 | 7241 titer |
| Cohort C: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: II Run:365 Days PD2 | 12902 titer |
| Cohort C: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: II Run:28 Days PD2 | 6967 titer |
| Cohort C: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:7 Days PD1 | 3763 titer |
| Cohort C: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: II Run:152 Days PD2 | 8778 titer |
| Cohort C: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: II Run:365 Days PD2 | 3484 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:7 Days PD2 | 178669 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:28 Days PD2 | 89334 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:7 Days PD1 | 300484 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: II Run:Pre-Dose 1 | 5120 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:21 Days PD1 | 137772 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:28 Days PD1 | 126338 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: II Run:Pre-Dose 1 | 587 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run: Pre-Dose 1 | 1280 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: II Run:28 Days PD2 | 115852 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:7 Days PD1 | 126338 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: II Run:152 Days PD2 | 31584 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:21 Days PD1 | 212474 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: II Run:365 Days PD2 | 37098 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: II Run:28 Days PD2 | 89334 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: II Run:152 Days PD2 | 48710 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:7 Days PD2 | 126338 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: II Run:365 Days PD2 | 18549 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:28 Days PD2 | 115852 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:28 Days PD1 | 106230 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run: Pre-Dose 1 | 6089 titer |
| Cohort D: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: II Run:365 Days PD2 | 353 titer |
| Cohort D: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:21 Days PD1 | 861 titer |
| Cohort D: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:7 Days PD2 | 861 titer |
| Cohort D: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:28 Days PD1 | 707 titer |
| Cohort D: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:28 Days PD1 | 7608 titer |
| Cohort D: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: II Run:Pre-Dose 1 | 390 titer |
| Cohort D: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: II Run:365 Days PD2 | 5653 titer |
| Cohort D: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: II Run:Pre-Dose 1 | 5653 titer |
| Cohort D: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:7 Days PD2 | 10240 titer |
| Cohort D: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: II Run:28 Days PD2 | 353 titer |
| Cohort D: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:7 Days PD1 | 7608 titer |
| Cohort D: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:28 Days PD2 | 861 titer |
| Cohort D: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run:7 Days PD1 | 861 titer |
| Cohort D: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: II Run:152 Days PD2 | 390 titer |
| Cohort D: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run: Pre-Dose 1 | 9275 titer |
| Cohort D: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:21 Days PD1 | 8400 titer |
| Cohort D: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: I Run:28 Days PD2 | 10240 titer |
| Cohort D: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: II Run:152 Days PD2 | 5653 titer |
| Cohort D: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GII.4: II Run:28 Days PD2 | 6241 titer |
| Cohort D: Placebo | GMT of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig Enzyme-Linked Immunosorbent Assay (ELISA) | GI.1: I Run: Pre-Dose 1 | 861 titer |
Secondary
GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG
Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
Time frame: I run: predose 1 and 7, 21, 28 days PD1, and 7 and 28 days PD2; II run: predose 1 and 28, 152 and 365 days PD2 (up to Day 393)
Population: PP population included all participants who received both doses of study product and with no protocol deviations likely to affect the immunogenicity assessment.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run: Pre-Dose 1 | 13 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:28 Days PD1 | 261 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:28 Days PD2 | 83 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:152 Days PD2 | 52 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:28 Days PD2 | 65 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:21 Days PD1 | 266 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:28 Days PD1 | 139 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:Pre-Dose 1 | 5 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:7 Days PD2 | 144 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:365 Days PD2 | 58 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run: Pre-Dose 1 | 38 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:152 Days PD2 | 44 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:365 Days PD2 | 28 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:28 Days PD2 | 286 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:28 Days PD2 | 174 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:7 Days PD1 | 97 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:7 Days PD1 | 211 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:21 Days PD1 | 142 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:7 Days PD2 | 281 titer |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:Pre-Dose 1 | 13 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:7 Days PD2 | 167 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:365 Days PD2 | 53 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run: Pre-Dose 1 | 19 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:365 Days PD2 | 51 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:7 Days PD1 | 237 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:152 Days PD2 | 44 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:21 Days PD1 | 184 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:28 Days PD2 | 74 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:28 Days PD1 | 152 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:Pre-Dose 1 | 11 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run: Pre-Dose 1 | 8 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:28 Days PD2 | 125 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:28 Days PD2 | 168 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:7 Days PD2 | 132 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:Pre-Dose 1 | 7 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:28 Days PD1 | 98 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:28 Days PD2 | 94 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:21 Days PD1 | 128 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:152 Days PD2 | 65 titer |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:7 Days PD1 | 136 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:21 Days PD1 | 35 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:152 Days PD2 | 46 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:28 Days PD2 | 605 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:28 Days PD2 | 34 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:Pre-Dose 1 | 5 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run: Pre-Dose 1 | 28 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:7 Days PD1 | 43 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run: Pre-Dose 1 | 5 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:28 Days PD1 | 31 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:7 Days PD1 | 1650 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:152 Days PD2 | 18 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:7 Days PD2 | 723 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:365 Days PD2 | 28 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:28 Days PD2 | 57 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:28 Days PD1 | 910 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:Pre-Dose 1 | 5 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:21 Days PD1 | 1165 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:28 Days PD2 | 89 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:365 Days PD2 | 13 titer |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:7 Days PD2 | 34 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:28 Days PD2 | 113 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:28 Days PD1 | 878 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:7 Days PD1 | 1171 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:28 Days PD2 | 41 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:7 Days PD2 | 957 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:7 Days PD1 | 40 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:152 Days PD2 | 18 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:7 Days PD2 | 42 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:28 Days PD2 | 737 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:28 Days PD1 | 37 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run: Pre-Dose 1 | 17 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:Pre-Dose 1 | 5 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run: Pre-Dose 1 | 22 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:21 Days PD1 | 39 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:365 Days PD2 | 46 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:152 Days PD2 | 73 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:28 Days PD2 | 37 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:21 Days PD1 | 1235 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:Pre-Dose 1 | 10 titer |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:365 Days PD2 | 23 titer |
| Cohort A1-A4: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run: Pre-Dose 1 | 9 titer |
| Cohort A1-A4: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:152 Days PD2 | 7 titer |
| Cohort A1-A4: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:28 Days PD2 | 8 titer |
| Cohort A1-A4: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:Pre-Dose 1 | 5 titer |
| Cohort A1-A4: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:7 Days PD2 | 25 titer |
| Cohort A1-A4: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:7 Days PD1 | 14 titer |
| Cohort A1-A4: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:7 Days PD2 | 10 titer |
| Cohort A1-A4: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:152 Days PD2 | 8 titer |
| Cohort A1-A4: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:28 Days PD2 | 10 titer |
| Cohort A1-A4: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:28 Days PD2 | 27 titer |
| Cohort A1-A4: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:28 Days PD1 | 16 titer |
| Cohort A1-A4: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:28 Days PD1 | 7 titer |
| Cohort A1-A4: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run: Pre-Dose 1 | 19 titer |
| Cohort A1-A4: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:28 Days PD2 | 11 titer |
| Cohort A1-A4: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:21 Days PD1 | 7 titer |
| Cohort A1-A4: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:Pre-Dose 1 | 7 titer |
| Cohort A1-A4: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:7 Days PD1 | 5 titer |
| Cohort A1-A4: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:365 Days PD2 | 6 titer |
| Cohort A1-A4: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:365 Days PD2 | 6 titer |
| Cohort A1-A4: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:21 Days PD1 | 13 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:28 Days PD2 | 104 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:365 Days PD2 | 75 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run: Pre-Dose 1 | 9 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:7 Days PD1 | 375 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:21 Days PD1 | 457 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:28 Days PD1 | 429 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:7 Days PD2 | 513 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:28 Days PD2 | 518 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:Pre-Dose 1 | 8 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:28 Days PD2 | 270 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:152 Days PD2 | 135 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run: Pre-Dose 1 | 8 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:7 Days PD1 | 54 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:21 Days PD1 | 93 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:28 Days PD1 | 86 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:7 Days PD2 | 99 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:28 Days PD2 | 102 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:Pre-Dose 1 | 6 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:152 Days PD2 | 77 titer |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:365 Days PD2 | 44 titer |
| Cohort B: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:365 Days PD2 | 6 titer |
| Cohort B: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:28 Days PD2 | 6 titer |
| Cohort B: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:28 Days PD1 | 5 titer |
| Cohort B: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:7 Days PD1 | 7 titer |
| Cohort B: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:Pre-Dose 1 | 7 titer |
| Cohort B: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:28 Days PD2 | 5 titer |
| Cohort B: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:365 Days PD2 | 6 titer |
| Cohort B: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:7 Days PD1 | 5 titer |
| Cohort B: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run: Pre-Dose 1 | 5 titer |
| Cohort B: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:152 Days PD2 | 7 titer |
| Cohort B: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:21 Days PD1 | 5 titer |
| Cohort B: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:Pre-Dose 1 | 4 titer |
| Cohort B: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:28 Days PD1 | 6 titer |
| Cohort B: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:28 Days PD2 | 6 titer |
| Cohort B: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:28 Days PD2 | 6 titer |
| Cohort B: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:7 Days PD2 | 7 titer |
| Cohort B: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:7 Days PD2 | 5 titer |
| Cohort B: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run: Pre-Dose 1 | 7 titer |
| Cohort B: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:21 Days PD1 | 5 titer |
| Cohort B: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:152 Days PD2 | 5 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:28 Days PD2 | 103 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:7 Days PD1 | 23 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:152 Days PD2 | 82 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:21 Days PD1 | 29 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:Pre-Dose 1 | 9 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:28 Days PD1 | 30 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:28 Days PD2 | 177 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:7 Days PD2 | 34 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:7 Days PD2 | 157 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:365 Days PD2 | 22 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:28 Days PD2 | 36 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:28 Days PD1 | 110 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:Pre-Dose 1 | 9 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:21 Days PD1 | 97 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:28 Days PD2 | 52 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:7 Days PD1 | 96 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:152 Days PD2 | 33 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run: Pre-Dose 1 | 14 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:365 Days PD2 | 57 titer |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run: Pre-Dose 1 | 10 titer |
| Cohort C: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:21 Days PD1 | 13 titer |
| Cohort C: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:365 Days PD2 | 13 titer |
| Cohort C: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:28 Days PD2 | 7 titer |
| Cohort C: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:21 Days PD1 | 9 titer |
| Cohort C: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:Pre-Dose 1 | 7 titer |
| Cohort C: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:28 Days PD1 | 10 titer |
| Cohort C: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:28 Days PD2 | 8 titer |
| Cohort C: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:365 Days PD2 | 10 titer |
| Cohort C: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:7 Days PD2 | 10 titer |
| Cohort C: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:7 Days PD1 | 9 titer |
| Cohort C: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:Pre-Dose 1 | 8 titer |
| Cohort C: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:7 Days PD1 | 10 titer |
| Cohort C: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:152 Days PD2 | 8 titer |
| Cohort C: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:28 Days PD2 | 7 titer |
| Cohort C: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:7 Days PD2 | 8 titer |
| Cohort C: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:28 Days PD1 | 7 titer |
| Cohort C: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:28 Days PD2 | 10 titer |
| Cohort C: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run: Pre-Dose 1 | 11 titer |
| Cohort C: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run: Pre-Dose 1 | 6 titer |
| Cohort C: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:152 Days PD2 | 8 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:28 Days PD1 | 148 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:152 Days PD2 | 20 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:7 Days PD2 | 144 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:Pre-Dose 1 | 3 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:28 Days PD1 | 93 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run: Pre-Dose 1 | 11 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:28 Days PD2 | 140 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:21 Days PD1 | 107 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:365 Days PD2 | 21 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:Pre-Dose 1 | 3 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:7 Days PD1 | 178 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:7 Days PD1 | 82 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:28 Days PD2 | 37 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:28 Days PD2 | 80 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run: Pre-Dose 1 | 7 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:365 Days PD2 | 16 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:28 Days PD2 | 127 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:152 Days PD2 | 35 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:21 Days PD1 | 180 titer |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:7 Days PD2 | 108 titer |
| Cohort D: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run: Pre-Dose 1 | 5 titer |
| Cohort D: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:28 Days PD1 | 5 titer |
| Cohort D: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run: Pre-Dose 1 | 13 titer |
| Cohort D: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:152 Days PD2 | 5 titer |
| Cohort D: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:28 Days PD2 | 3 titer |
| Cohort D: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:28 Days PD2 | 5 titer |
| Cohort D: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:7 Days PD2 | 5 titer |
| Cohort D: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:365 Days PD2 | 3 titer |
| Cohort D: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:365 Days PD2 | 5 titer |
| Cohort D: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:21 Days PD1 | 17 titer |
| Cohort D: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:7 Days PD2 | 15 titer |
| Cohort D: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:28 Days PD2 | 17 titer |
| Cohort D: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:7 Days PD1 | 5 titer |
| Cohort D: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:Pre-Dose 1 | 6 titer |
| Cohort D: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:152 Days PD2 | 3 titer |
| Cohort D: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:7 Days PD1 | 16 titer |
| Cohort D: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:Pre-Dose 1 | 3 titer |
| Cohort D: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:28 Days PD2 | 6 titer |
| Cohort D: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:21 Days PD1 | 5 titer |
| Cohort D: Placebo | GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:28 Days PD1 | 16 titer |
Secondary
GMT of Serum Anti-norovirus GI.1 and GII.4 VLP IgM
Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
Time frame: I run: predose 1 and 7, 21, 28 days PD1, and 7 and 28 days PD2; II run: predose 1 and 28, 152 and 365 days PD2 (up to Day 393)
Population: Data was not collected because serum specimens were not tested for specific IgM antibodies to Norovirus GI.1 and GII.4 VLPs as per the change in planned analysis, because this measurement was not informative in a previous study LV01-103 (NCT00973284).
Secondary
Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA
Seroresponse was defined as a 4-fold increase in antibody titer compared to pre-immunization titers. Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
Time frame: I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)
Population: PP population where baseline and specified post-baseline assessment were available. PP population included all participants who received both doses of study product and with no protocol deviations likely to affect the immunogenicity assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:7 Days PD2 | 100.0 percentage of participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:21 Days PD1 | 55.6 percentage of participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:28 Days PD2 | 55.6 percentage of participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: II Run:365 Days PD2 | 66.7 percentage of participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:28 Days PD2 | 100.0 percentage of participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:7 Days PD1 | 66.7 percentage of participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:7 Days PD1 | 88.9 percentage of participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:7 Days PD2 | 66.7 percentage of participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:28 Days PD1 | 100.0 percentage of participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:21 Days PD1 | 100.0 percentage of participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: II Run:365 Days PD2 | 33.3 percentage of participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: II Run:152 Days PD2 | 50.0 percentage of participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: II Run:28 Days PD2 | 66.7 percentage of participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: II Run:152 Days PD2 | 87.5 percentage of participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: II Run:28 Days PD2 | 100.0 percentage of participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:28 Days PD1 | 55.6 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:28 Days PD1 | 87.5 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:7 Days PD1 | 100.0 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:7 Days PD2 | 100.0 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: II Run:365 Days PD2 | 100.0 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:7 Days PD2 | 71.4 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:21 Days PD1 | 87.5 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: II Run:152 Days PD2 | 57.1 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:28 Days PD2 | 85.7 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:21 Days PD1 | 100.0 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: II Run:365 Days PD2 | 57.1 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: II Run:152 Days PD2 | 100.0 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: II Run:28 Days PD2 | 71.4 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:28 Days PD1 | 100.0 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: II Run:28 Days PD2 | 100.0 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:7 Days PD1 | 75.0 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:28 Days PD2 | 100.0 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: II Run:365 Days PD2 | 100.0 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: II Run:152 Days PD2 | 100.0 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: II Run:365 Days PD2 | 62.5 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: II Run:152 Days PD2 | 66.7 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:21 Days PD1 | 100.0 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: II Run:28 Days PD2 | 88.9 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:7 Days PD2 | 80.0 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:28 Days PD1 | 100.0 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:28 Days PD1 | 80.0 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:7 Days PD2 | 100.0 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:21 Days PD1 | 80.0 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:28 Days PD2 | 100.0 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:28 Days PD2 | 88.9 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:7 Days PD1 | 80.0 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:7 Days PD1 | 100.0 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: II Run:28 Days PD2 | 100.0 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:7 Days PD1 | 100.0 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:28 Days PD2 | 100.0 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: II Run:28 Days PD2 | 100.0 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: II Run:365 Days PD2 | 42.9 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:28 Days PD1 | 100.0 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:7 Days PD2 | 75.0 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:21 Days PD1 | 100.0 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: II Run:365 Days PD2 | 100.0 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: II Run:152 Days PD2 | 50.0 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: II Run:28 Days PD2 | 75.0 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: II Run:152 Days PD2 | 100.0 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:28 Days PD2 | 75.0 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:7 Days PD2 | 100.0 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:7 Days PD1 | 71.4 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:21 Days PD1 | 75.0 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:28 Days PD1 | 75.0 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:7 Days PD2 | 12.5 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: II Run:28 Days PD2 | 14.3 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: II Run:152 Days PD2 | 14.3 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:21 Days PD1 | 0.0 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:28 Days PD1 | 0.0 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:7 Days PD2 | 25.0 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:28 Days PD2 | 25.0 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: II Run:365 Days PD2 | 14.3 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: II Run:28 Days PD2 | 14.3 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: II Run:152 Days PD2 | 0.0 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:7 Days PD1 | 0.0 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: II Run:365 Days PD2 | 0.0 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:7 Days PD1 | 0.0 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:21 Days PD1 | 0.0 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:28 Days PD1 | 12.5 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:28 Days PD2 | 12.5 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: II Run:152 Days PD2 | 87.5 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:28 Days PD1 | 87.5 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:21 Days PD1 | 100.0 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: II Run:365 Days PD2 | 87.5 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:7 Days PD2 | 100.0 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: II Run:28 Days PD2 | 100.0 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:28 Days PD2 | 100.0 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: II Run:28 Days PD2 | 87.5 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:7 Days PD1 | 87.5 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:21 Days PD1 | 100.0 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:7 Days PD2 | 87.5 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: II Run:152 Days PD2 | 100.0 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:28 Days PD2 | 100.0 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: II Run:365 Days PD2 | 62.5 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:28 Days PD1 | 100.0 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:7 Days PD1 | 75.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:7 Days PD1 | 0.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: II Run:28 Days PD2 | 0.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: II Run:365 Days PD2 | 0.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:28 Days PD2 | 0.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:7 Days PD1 | 0.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:7 Days PD2 | 0.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: II Run:365 Days PD2 | 10.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:21 Days PD1 | 0.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:28 Days PD1 | 0.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:28 Days PD1 | 0.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:7 Days PD2 | 0.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:21 Days PD1 | 0.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: II Run:152 Days PD2 | 10.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: II Run:28 Days PD2 | 0.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: II Run:152 Days PD2 | 0.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:28 Days PD2 | 0.0 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:7 Days PD2 | 77.8 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: II Run:365 Days PD2 | 77.8 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: II Run:152 Days PD2 | 100.0 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:28 Days PD1 | 77.8 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:7 Days PD1 | 66.7 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:7 Days PD2 | 100.0 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: II Run:28 Days PD2 | 100.0 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: II Run:152 Days PD2 | 66.7 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: II Run:28 Days PD2 | 77.8 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: II Run:365 Days PD2 | 55.6 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:28 Days PD1 | 88.9 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:21 Days PD1 | 75.0 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:21 Days PD1 | 87.5 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:28 Days PD2 | 100.0 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:7 Days PD1 | 88.9 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:28 Days PD2 | 77.8 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: II Run:152 Days PD2 | 11.1 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: II Run:365 Days PD2 | 11.1 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:28 Days PD2 | 0.0 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:28 Days PD1 | 0.0 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:7 Days PD1 | 0.0 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:21 Days PD1 | 0.0 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:7 Days PD2 | 0.0 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: II Run:152 Days PD2 | 0.0 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:28 Days PD2 | 11.1 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: II Run:28 Days PD2 | 0.0 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:7 Days PD2 | 0.0 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: II Run:365 Days PD2 | 22.2 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:7 Days PD1 | 0.0 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: II Run:28 Days PD2 | 0.0 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:21 Days PD1 | 0.0 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:28 Days PD1 | 0.0 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:7 Days PD2 | 100.0 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:7 Days PD1 | 100.0 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:21 Days PD1 | 100.0 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:28 Days PD1 | 100.0 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:28 Days PD2 | 100.0 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: II Run:28 Days PD2 | 100.0 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: II Run:152 Days PD2 | 100.0 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: II Run:365 Days PD2 | 100.0 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:7 Days PD1 | 87.5 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:21 Days PD1 | 87.5 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:28 Days PD1 | 87.5 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:7 Days PD2 | 100.0 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:28 Days PD2 | 100.0 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: II Run:28 Days PD2 | 100.0 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: II Run:152 Days PD2 | 87.5 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: II Run:365 Days PD2 | 100.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:7 Days PD2 | 0.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:28 Days PD1 | 0.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:21 Days PD1 | 0.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: II Run:365 Days PD2 | 0.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: II Run:152 Days PD2 | 0.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:7 Days PD1 | 0.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: II Run:365 Days PD2 | 0.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: II Run:152 Days PD2 | 0.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: II Run:28 Days PD2 | 0.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:28 Days PD2 | 0.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:7 Days PD2 | 0.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:28 Days PD1 | 0.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:21 Days PD1 | 0.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GI.1: I Run:7 Days PD1 | 0.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: II Run:28 Days PD2 | 0.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse (4-Fold Rise) of Anti-norovirus GI.1 and GII.4 VLP IgA, IgG, and IgM Combined Using Pan-Ig ELISA | GII.4: I Run:28 Days PD2 | 0.0 percentage of participants |
Secondary
Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA
Seroresponse was defined as a 4-fold increase in antibody titer compared to pre-immunization titers. Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
Time frame: I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)
Population: PP population where baseline and specified post-baseline assessment were available. PP population included all participants who received both doses of study product and with no protocol deviations likely to affect the immunogenicity assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:28 Days PD2 | 77.8 percentage of participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:21 Days PD1 | 88.9 percentage of participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:28 Days PD1 | 77.8 percentage of participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:7 Days PD2 | 77.8 percentage of participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:7 Days PD1 | 77.8 percentage of participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: II Run:28 Days PD2 | 66.7 percentage of participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: II Run:152 Days PD2 | 62.5 percentage of participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: II Run:365 Days PD2 | 50.0 percentage of participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:7 Days PD1 | 55.6 percentage of participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:21 Days PD1 | 55.6 percentage of participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:28 Days PD1 | 55.6 percentage of participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:7 Days PD2 | 44.4 percentage of participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:28 Days PD2 | 44.4 percentage of participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: II Run:28 Days PD2 | 77.8 percentage of participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: II Run:152 Days PD2 | 12.5 percentage of participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: II Run:365 Days PD2 | 0.0 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: II Run:365 Days PD2 | 42.6 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: II Run:28 Days PD2 | 71.4 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:7 Days PD1 | 100.0 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: II Run:152 Days PD2 | 42.9 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:28 Days PD1 | 100.0 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: II Run:28 Days PD2 | 100.0 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:28 Days PD2 | 57.1 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:7 Days PD2 | 71.4 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:28 Days PD1 | 62.5 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:7 Days PD2 | 100.0 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:21 Days PD1 | 75.0 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:7 Days PD1 | 75.0 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: II Run:365 Days PD2 | 42.9 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: II Run:152 Days PD2 | 42.9 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:28 Days PD2 | 100.0 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:21 Days PD1 | 100.0 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:28 Days PD1 | 50.0 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: II Run:28 Days PD2 | 55.6 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: II Run:365 Days PD2 | 37.5 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:7 Days PD1 | 90.0 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:28 Days PD2 | 88.9 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: II Run:152 Days PD2 | 33.3 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:7 Days PD2 | 100.0 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:21 Days PD1 | 50.0 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:28 Days PD1 | 90.0 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:21 Days PD1 | 100.0 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: II Run:28 Days PD2 | 55.6 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: II Run:365 Days PD2 | 37.5 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:28 Days PD2 | 44.4 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:7 Days PD1 | 70.0 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:7 Days PD2 | 50.0 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: II Run:152 Days PD2 | 44.4 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:7 Days PD2 | 100.0 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:28 Days PD1 | 87.5 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:28 Days PD2 | 87.5 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: II Run:28 Days PD2 | 62.5 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: II Run:152 Days PD2 | 50.0 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: II Run:365 Days PD2 | 57.1 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: II Run:365 Days PD2 | 14.3 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:7 Days PD1 | 42.9 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:21 Days PD1 | 25.0 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:28 Days PD1 | 12.5 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:7 Days PD2 | 25.0 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:28 Days PD2 | 25.0 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: II Run:28 Days PD2 | 37.5 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: II Run:152 Days PD2 | 25.0 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:7 Days PD1 | 100.0 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:21 Days PD1 | 100.0 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:21 Days PD1 | 0.0 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:7 Days PD2 | 0.0 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: II Run:365 Days PD2 | 0.0 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: II Run:365 Days PD2 | 14.3 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: II Run:152 Days PD2 | 0.0 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:28 Days PD1 | 12.5 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:7 Days PD1 | 0.0 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:28 Days PD1 | 0.0 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: II Run:28 Days PD2 | 0.0 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:7 Days PD2 | 12.5 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: II Run:28 Days PD2 | 14.3 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:21 Days PD1 | 0.0 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:7 Days PD1 | 0.0 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:28 Days PD2 | 0.0 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:28 Days PD2 | 12.5 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: II Run:152 Days PD2 | 14.3 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:28 Days PD1 | 50.0 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:28 Days PD2 | 50.0 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: II Run:152 Days PD2 | 25.0 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:21 Days PD1 | 100.0 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:21 Days PD1 | 75.0 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: II Run:152 Days PD2 | 100.0 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:28 Days PD2 | 100.0 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: II Run:28 Days PD2 | 100.0 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:7 Days PD1 | 100.0 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: II Run:365 Days PD2 | 100.0 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:7 Days PD2 | 62.5 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:28 Days PD1 | 100.0 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: II Run:28 Days PD2 | 50.0 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:7 Days PD2 | 100.0 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: II Run:365 Days PD2 | 25.0 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:7 Days PD1 | 62.5 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:7 Days PD2 | 0.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:28 Days PD2 | 0.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:28 Days PD1 | 0.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: II Run:365 Days PD2 | 0.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: II Run:28 Days PD2 | 0.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:28 Days PD2 | 0.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:7 Days PD1 | 0.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:7 Days PD2 | 0.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:7 Days PD1 | 0.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: II Run:152 Days PD2 | 0.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:21 Days PD1 | 0.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:21 Days PD1 | 0.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: II Run:28 Days PD2 | 0.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:28 Days PD1 | 0.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: II Run:365 Days PD2 | 10.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: II Run:152 Days PD2 | 0.0 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: II Run:365 Days PD2 | 22.2 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:28 Days PD2 | 88.9 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: II Run:365 Days PD2 | 66.7 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:7 Days PD2 | 88.9 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:28 Days PD2 | 22.2 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:28 Days PD1 | 22.2 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: II Run:28 Days PD2 | 100.0 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: II Run:152 Days PD2 | 33.3 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:21 Days PD1 | 87.5 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: II Run:152 Days PD2 | 66.7 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:28 Days PD1 | 77.8 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:21 Days PD1 | 25.0 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:7 Days PD1 | 55.6 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:7 Days PD2 | 33.3 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:7 Days PD1 | 88.9 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: II Run:28 Days PD2 | 33.3 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: II Run:28 Days PD2 | 0.0 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: II Run:152 Days PD2 | 0.0 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:7 Days PD2 | 0.0 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: II Run:365 Days PD2 | 0.0 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:7 Days PD1 | 0.0 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:7 Days PD1 | 0.0 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:21 Days PD1 | 0.0 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:28 Days PD1 | 0.0 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:28 Days PD1 | 0.0 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:7 Days PD2 | 0.0 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:28 Days PD2 | 0.0 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: II Run:365 Days PD2 | 11.1 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: II Run:28 Days PD2 | 0.0 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: II Run:152 Days PD2 | 0.0 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:21 Days PD1 | 0.0 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:28 Days PD2 | 0.0 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: II Run:152 Days PD2 | 75.0 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:28 Days PD1 | 62.5 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:28 Days PD1 | 75.0 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:7 Days PD1 | 87.5 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: II Run:152 Days PD2 | 50.0 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: II Run:28 Days PD2 | 62.5 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: II Run:365 Days PD2 | 57.1 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:21 Days PD1 | 75.0 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:7 Days PD1 | 87.5 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:21 Days PD1 | 75.0 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: II Run:28 Days PD2 | 87.5 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:28 Days PD2 | 62.5 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: II Run:365 Days PD2 | 71.4 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:7 Days PD2 | 62.5 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:7 Days PD2 | 62.5 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:28 Days PD2 | 62.5 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: II Run:152 Days PD2 | 0.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:7 Days PD1 | 0.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:28 Days PD1 | 0.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: II Run:28 Days PD2 | 0.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: II Run:365 Days PD2 | 0.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:28 Days PD1 | 0.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:7 Days PD2 | 0.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:7 Days PD2 | 0.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:28 Days PD2 | 0.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: II Run:28 Days PD2 | 0.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:28 Days PD2 | 0.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: II Run:152 Days PD2 | 0.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GI.1: I Run:21 Days PD1 | 0.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:21 Days PD1 | 0.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: II Run:365 Days PD2 | 0.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgA | GII.4: I Run:7 Days PD1 | 0.0 percentage of participants |
Secondary
Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG
Seroresponse was defined as a 4-fold increase in antibody titer compared to pre-immunization titers. Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
Time frame: I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)
Population: PP population where baseline and specified post-baseline assessment were available. PP population included all participants who received both doses of study product and with no protocol deviations likely to affect the immunogenicity assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:7 Days PD1 | 66.7 percentage of participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:152 Days PD2 | 50.0 percentage of participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:28 Days PD2 | 77.8 percentage of participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:7 Days PD2 | 77.8 percentage of participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:28 Days PD2 | 33.3 percentage of participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:28 Days PD1 | 77.8 percentage of participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:28 Days PD2 | 77.8 percentage of participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:7 Days PD1 | 22.2 percentage of participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:152 Days PD2 | 50.0 percentage of participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:365 Days PD2 | 33.3 percentage of participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:7 Days PD2 | 44.4 percentage of participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:21 Days PD1 | 33.3 percentage of participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:28 Days PD2 | 55.6 percentage of participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:365 Days PD2 | 50.0 percentage of participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:28 Days PD1 | 33.3 percentage of participants |
| Cohort A1: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 5/5 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:21 Days PD1 | 77.8 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:21 Days PD1 | 100.0 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:152 Days PD2 | 42.9 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:28 Days PD2 | 57.1 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:28 Days PD2 | 100.0 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:365 Days PD2 | 85.7 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:28 Days PD2 | 100.0 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:152 Days PD2 | 85.7 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:7 Days PD1 | 62.5 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:28 Days PD1 | 62.5 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:7 Days PD1 | 100.0 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:28 Days PD1 | 87.5 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:21 Days PD1 | 62.5 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:7 Days PD2 | 57.1 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:365 Days PD2 | 57.1 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:28 Days PD2 | 71.4 percentage of participants |
| Cohort A2: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 15/15 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:7 Days PD2 | 100.0 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:28 Days PD1 | 100.0 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:21 Days PD1 | 70.0 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:152 Days PD2 | 88.9 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:365 Days PD2 | 50.0 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:7 Days PD1 | 80.0 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:28 Days PD1 | 70.0 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:21 Days PD1 | 100.0 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:7 Days PD2 | 70.0 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:7 Days PD2 | 100.0 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:365 Days PD2 | 75.0 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:28 Days PD2 | 66.7 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:28 Days PD2 | 100.0 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:28 Days PD2 | 88.9 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:28 Days PD2 | 77.8 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:7 Days PD1 | 100.0 percentage of participants |
| Cohort A3: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:152 Days PD2 | 66.7 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:7 Days PD2 | 100.0 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:7 Days PD2 | 25.0 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:21 Days PD1 | 12.5 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:28 Days PD2 | 50.0 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:28 Days PD2 | 100.0 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:7 Days PD1 | 100.0 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:152 Days PD2 | 25.0 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:21 Days PD1 | 100.0 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:28 Days PD1 | 12.5 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:28 Days PD1 | 100.0 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:152 Days PD2 | 87.5 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:7 Days PD1 | 28.6 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:365 Days PD2 | 28.6 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:28 Days PD2 | 12.5 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:365 Days PD2 | 85.7 percentage of participants |
| Cohort A4:Norovirus Bivalent GI.1/GII.4 VLP Vaccine 150/150mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:28 Days PD2 | 100.0 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:28 Days PD2 | 12.5 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:7 Days PD2 | 12.5 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:28 Days PD1 | 12.5 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:7 Days PD2 | 12.5 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:7 Days PD1 | 0.0 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:365 Days PD2 | 0.0 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:28 Days PD2 | 12.5 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:28 Days PD2 | 14.3 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:152 Days PD2 | 14.3 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:152 Days PD2 | 14.3 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:365 Days PD2 | 14.3 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:28 Days PD2 | 14.3 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:7 Days PD1 | 0.0 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:21 Days PD1 | 0.0 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:21 Days PD1 | 0.0 percentage of participants |
| Cohort A1-A4: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:28 Days PD1 | 0.0 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:7 Days PD2 | 87.5 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:152 Days PD2 | 62.5 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:152 Days PD2 | 87.5 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:28 Days PD2 | 75.0 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:28 Days PD1 | 87.5 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:7 Days PD1 | 87.5 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:28 Days PD2 | 87.5 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:7 Days PD2 | 75.0 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:365 Days PD2 | 87.5 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:21 Days PD1 | 87.5 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:21 Days PD1 | 87.5 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:7 Days PD1 | 62.5 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:28 Days PD2 | 87.5 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:28 Days PD1 | 75.0 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:365 Days PD2 | 50.0 percentage of participants |
| Cohort B: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:28 Days PD2 | 100.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:21 Days PD1 | 0.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:7 Days PD1 | 0.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:21 Days PD1 | 0.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:28 Days PD2 | 0.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:7 Days PD2 | 0.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:28 Days PD2 | 0.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:28 Days PD2 | 0.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:7 Days PD1 | 0.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:28 Days PD1 | 0.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:152 Days PD2 | 0.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:28 Days PD2 | 0.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:365 Days PD2 | 10.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:7 Days PD2 | 0.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:28 Days PD1 | 0.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:152 Days PD2 | 10.0 percentage of participants |
| Cohort B: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:365 Days PD2 | 0.0 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:28 Days PD1 | 55.6 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:21 Days PD1 | 50.0 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:28 Days PD1 | 44.4 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:7 Days PD2 | 44.4 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:28 Days PD2 | 44.4 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:28 Days PD2 | 66.7 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:152 Days PD2 | 66.7 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:365 Days PD2 | 55.6 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:7 Days PD1 | 55.6 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:21 Days PD1 | 50.0 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:7 Days PD1 | 33.3 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:7 Days PD2 | 66.7 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:28 Days PD2 | 77.8 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:28 Days PD2 | 88.9 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:152 Days PD2 | 88.9 percentage of participants |
| Cohort C: Norovirus Bivalent GI.1/GII.4 VLP Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:365 Days PD2 | 66.7 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:28 Days PD2 | 0.0 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:28 Days PD2 | 0.0 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:28 Days PD2 | 0.0 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:152 Days PD2 | 0.0 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:7 Days PD2 | 0.0 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:152 Days PD2 | 11.1 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:28 Days PD2 | 0.0 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:28 Days PD1 | 0.0 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:21 Days PD1 | 0.0 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:365 Days PD2 | 11.1 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:28 Days PD1 | 0.0 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:7 Days PD1 | 0.0 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:7 Days PD1 | 0.0 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:21 Days PD1 | 0.0 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:365 Days PD2 | 22.2 percentage of participants |
| Cohort C: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:7 Days PD2 | 0.0 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:28 Days PD1 | 75.0 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:21 Days PD1 | 75.0 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:28 Days PD2 | 75.0 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:7 Days PD1 | 75.0 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:365 Days PD2 | 85.7 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:28 Days PD2 | 100.0 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:152 Days PD2 | 75.0 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:28 Days PD2 | 87.5 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:7 Days PD1 | 75.0 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:152 Days PD2 | 75.0 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:28 Days PD2 | 100.0 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:7 Days PD2 | 87.5 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:28 Days PD1 | 87.5 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:365 Days PD2 | 71.4 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:21 Days PD1 | 87.5 percentage of participants |
| Cohort D: Norovirus Bivalent VLP GI.1/GII.4 Vaccine 50/50 mcg | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:7 Days PD2 | 75.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:7 Days PD2 | 0.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:21 Days PD1 | 0.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:7 Days PD1 | 0.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:28 Days PD1 | 0.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:7 Days PD2 | 0.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:365 Days PD2 | 0.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:7 Days PD1 | 0.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:28 Days PD1 | 0.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:28 Days PD2 | 0.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:28 Days PD2 | 0.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:365 Days PD2 | 0.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: II Run:152 Days PD2 | 0.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: I Run:28 Days PD2 | 0.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:152 Days PD2 | 0.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GII.4: I Run:21 Days PD1 | 0.0 percentage of participants |
| Cohort D: Placebo | Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgG | GI.1: II Run:28 Days PD2 | 0.0 percentage of participants |
Secondary
Percentage of Participants With Seroresponse for Serum Anti-norovirus GI.1 and GII.4 VLP IgM
Seroresponse was defined as a 4-fold increase in antibody titer compared to pre-immunization titers. Run I was defined as the initial analysis performed once Day 56 post dose data was available. Run II was defined as final analysis performed after all later time points were achieved.
Time frame: I run: 7, 21, 28 days PD1, 7 and 28 days PD2; II run: 28, 152 and 365 days PD2 (up to Day 393)
Population: Data was not collected because serum specimens were not tested for specific IgM antibodies to Norovirus GI.1 and GII.4 VLPs as per the change in planned analysis, because this measurement was not informative in a previous study LV01-103 (NCT00973284).