Norovirus
Conditions
Keywords
Norovirus
Brief summary
The purpose of this study is to further develop a formulation and dose regimen of the norovirus GI.1/GII.4 bivalent virus-like particle (VLP) vaccine that is immunogenic and safe in an elderly population aged 60 years and above.
Detailed description
The vaccine being tested in this study is called norovirus GI.1/GII.4 bivalent virus-like particle (VLP) vaccine adjuvanted with aluminum hydroxide (Formulation A) or adjuvanted with monophosphoryl lipid A (MPL) and aluminum hydroxide (Formulation B). Two norovirus vaccine formulations are being tested to select for further development the formulation that will generate an optimal specific antibody response that may provide protection against norovirus and is safe in a population aged 60 years and above. This study will look at side effects and the level of antibodies to norovirus formed in people who will be injected with different formulations of the norovirus vaccine candidate. The study will enroll approximately 325 patients. Participants will be randomly assigned (by chance) to one of five treatment groups. * Norovirus GI.1/GII.4 bivalent VLP vaccine (Formulation A) 1-dose, participants ≥ 60 years * Norovirus GI.1/GII.4 bivalent VLP vaccine (Formulation A) 2-dose, participants ≥ 60 years * Norovirus GI.1/GII.4 bivalent VLP vaccine (Formulation B) 1-dose, participants ≥ 60 years * Norovirus GI.1/GII.4 bivalent VLP vaccine (Formulation B) 2-dose, participants ≥ 60 years * Norovirus GI.1/GII.4 bivalent VLP vaccine (Formulation A) 1-dose, participants 18 to 49 years All participants in the age of 60 years and older will be administered either NoV vaccine (Formulation A or B) or placebo on Day 1 and NoV vaccine (Formulation A or B) on Day 29 of the study. In order to keep the treatment arms undisclosed to the patient and the doctor, those randomized to the one dose groups will receive a dose of placebo (this is a saline solution that has no active ingredient) on Day 1 followed by the NoV vaccine on Day 29. Those randomized to 2 doses with receive the NoV vaccine on Day 1 and Day 29. In case of an urgent medical need a participant can be unblinded. Adults aged 18 to 49 will receive placebo on Day 1 followed by NoV vaccine Formulation A on Day 29. Participants will be asked to record any reactions/ symptoms that may be related or not to the vaccine in a diary card for 28 days after each vaccination. This multi-center trial will be conducted in the United States of America. The overall time to participate in this study is up to 393 days. Participants will make multiple visits to the clinic including a final follow-up visit on Day 393.
Interventions
BIOLOGICALNorovirus GI.1/GII.4 Bivalent VLP Vaccine
Norovirus GI.1/GII.4 bivalent VLP vaccine adjuvanted with aluminum hydroxide, without MPL for IM injection
DRUG0.9% sodium chloride (saline)
norovirus bivalent placebo-matching vaccine
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Is aged 18 to 49 years, or 60 years and older at the time of enrollment; 2. Participants who are in good health, or in stable health status with no exclusionary medical or neuropsychiatric conditions at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and clinical judgment of the Investigator; 3. Participant signs and dates a written, Informed Consent Form (ICF) and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements; 4. Participants who can comply with trial procedures and are available for the duration of follow-up.
Exclusion criteria
1. Has a known hypersensitivity or allergy to any of the Norovirus (NoV) GI.1/GII.4 Bivalent virus-like particle (VLP) Vaccine components; 2. Has a clinically significant active infection (as assessed by the Investigator) or body temperature ≥38°C/100.4°F within 3 days of the intended date of vaccination; 3. Participants with the presence of significant acute or chronic, uncontrolled medical or neuropsychiatric illness. Uncontrolled was defined as: Requiring institution of new medical or surgical treatment within 3 months prior to immunization, or Requiring a change in medication dosage in the 3 months prior to immunization due to uncontrolled symptoms or drug toxicity (elective dosage adjustments in stable participants were acceptable), or Hospitalization or an event fulfilling the definition of a serious adverse event within 3 months prior immunization. 4. Has any unstable medical or neuropsychiatric condition, which in the Investigator's opinion poses a risk of unusual magnitude for the participant's age group of hospitalization, death, or an event meeting the definition of a serious adverse event within 2 months of immunization. The intent of this criterion is to recognize and allow for the frequent existence of significant health concerns in this population; but exclude those participants who are experiencing an acute decline in health status; 5. Has any medical or neuropsychiatric condition, which in the Investigator's opinion, rendered the participant incompetent to provide informed consent or unable to provide valid safety observations and reports; 6. Has behavioral or cognitive impairment or psychiatric disease that, in the opinion of the Investigator, may interfere with the participant's ability to participate in the trial; 7. Participants with any history of progressive or severe neurologic disorder, history of seizure, or history of neuro-inflammatory disease (e.g. Guillain-Barre syndrome); 8. Participants with history or any illness that, in the opinion of the Investigator, might interfere with the results of the trial or pose additional risk to the participants due to participation in the trial; 9. Has known or suspected autoimmune disease; 10. Has known or suspected impairment/alteration of immune function, including: Chronic use of oral steroids (Equivalent to 20 mg/day prednisone ≥ 12 weeks/≥ 2 mg/kg body weight/day prednisone ≥ 2 weeks) within 60 days prior to Day 1 (use of inhaled, intranasal, or topical corticosteroids is allowed). Receipt of parenteral steroids (Equivalent to 20 mg/day prednisone ≥ 12 weeks/≥ 2 mg/kg body weight/day prednisone ≥ 2 weeks) within 60 days prior to Day 1. Receipt of immunosuppressive therapy within 3 months prior to Day 1. Receipt of immunostimulants within 60 days prior to Day 1. Receipt of parenteral, epidural or intra-articular immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to Day 1 or planned during the full length of the trial. Human Immunodeficiency Virus (HIV) infection or HIV-related disease. Genetic immunodeficiency. 11. Has abnormalities of splenic or thymic function; 12. Has any significant disorder of coagulation or treatment with anticoagulant therapy that would increase the risk of intramuscular (IM) injection. Persons receiving prophylactic antiplatelet medication such as low dose of acetylsalicylic acid are eligible; 13. Has any serious chronic or progressive disease according to judgment of the Investigator: cancer (malignancy other than resolved/excised skin lesion), insulin dependent Type I diabetes (Type II diabetes is accepted), cardiac, renal or hepatic disease; 14. Has body mass index (BMI) greater than or equal to 35 kg/m\^2 (= weight in kg/\[height in meters\^2\]); 15. Is participating in any clinical trial with another investigational product 30 days prior to first trial visit or intent to participate in another clinical trial at any time during the conduct of this trial; 16. Participants who received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this trial or who are planning to receive any vaccine within 28 days of investigational vaccine administration; 17. Participants involved in trial conduct or their first degree relatives; 18. Has history of substance or alcohol abuse within the past 2 years; 19. Females who are pregnant or breastfeeding; 20. If female of childbearing potential, sexually active with a male partner who has not been sterilized, and has not used any of the acceptable contraceptive methods for at least 2 months prior to trial entry: Of childbearing potential is defined as status post onset of menarche and not meeting any of the following conditions: menopausal for at least 2 years, status after bilateral tubal ligation for at least 1 year, status after bilateral oophorectomy, or status after hysterectomy. Acceptable birth control methods are defined as one or more of the following: i. Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring); ii. Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse; iii. Intrauterine device (IUD); iv. Monogamous relationship with vasectomized partner. Partner must have been vasectomized for at least six months prior to the participants' trial entry. 21. If female of childbearing potential and sexually active, refusal to use an acceptable contraceptive method from Day 1 and throughout the duration of the trial. In addition, they must be advised not to donate ova during this period; 22. Females with any positive or indeterminate pregnancy test.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 and GII.4 Virus Like Particles (VLP) as Measured by Histoblood Group Antigen (HBGA) Blocking Assay on Day 57 | Day 57 | — |
| Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Within 7 days of first vaccination on Day 1 | Solicited local AEs at the injection site that occurred within 7 days after each vaccination were collected using a diary and included pain, erythema swelling and induration. |
| Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Within 7 days of second vaccination on Day 29 | Solicited local AEs at the injection site that occurred within 7 days after each vaccination were collected using a diary and included pain, erythema, swelling and induration. |
| Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Within 7 days of first vaccination on Day 1 | Solicited systemic AEs that occurred within 7 days after each vaccination were collected using a diary and included headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea. |
| Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Within 7 days of second vaccination on Day 29 | Solicited systemic AEs that occurred within 7 days after each vaccination were collected using a diary and included headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea. |
| Percentage of Participants With Elevated Body Temperature ≥38°C (Defined as Fever) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Within 7 days of first vaccination on Day 1 | The body temperature measurement was performed using the thermometer for 7 days after each vaccination. The highest body temperature observed each day was recorded on the diary card. An elevated temperature is ≥ 38 °C or 100.4°F (considered as fever). |
| Percentage of Participants With Elevated Body Temperature ≥38°C (Defined as Fever) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Within 7 days of second vaccination on Day 29 | The body temperature measurement was performed using the thermometer for 7 days after each vaccination. The highest body temperature observed each day was recorded on the diary card. An elevated temperature is ≥ 38 °C or 100.4°F (considered as fever). |
| Percentage of Participants With At Least One Unsolicited Adverse Event (AE) Within 28-days After First Vaccination on Day 1 | Within 28 days of first vaccination on Day 1 | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. |
| Percentage of Participants With At Least One Unsolicited Adverse Event (AE) Within 28-days After Second Vaccination on Day 29 | Within 28 days of second vaccination on Day 29 | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. |
| Percentage of Participants With At Least One Serious Adverse Event (SAE) | From first vaccination up to Day 393 | An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GMT of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Baseline (Day 1), Days 8, 29, 36, 57, 211 and 393 | GMT of anti-norovirus GI.1 VLP antibody titers measured by Pan-Ig ELISA are reported. |
| GMT of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Baseline (Day 1), Days 8, 29, 36, 57, 211 and 393 | GMT of anti-norovirus GII.4 VLP antibody titers measured by Pan-Ig ELISA are reported. |
| GMFR of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Days 8, 29, 36, 57, 211 and 393 | GMFR of anti-norovirus GI.1 VLP antibody titers measured by Pan-Ig ELISA are reported. The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level. |
| Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by HBGA Blocking Assay | Days 8, 29, 36, 211 and 393 | — |
| Percentage of Participants With At Least One Adverse Event of Special Interest (AESI) | From first vaccination up to Day 393 | AESIs are AEs that are not solicited local or systemic AEs, they are predefined AEs that required close monitoring and prompt reporting to the sponsor. AESI included protocol specified Cardiac Disorders, Gastrointestinal Disorders, Immune System Disorders, Infections and Infestations, Musculoskeletal and Connective Tissue Diseases, Neuroinflammatory Disorders, Renal and Urinary Disorders, Skin Disorders, Thyroid Disorders, Vascular Disorders and Other Disorders. |
| Percentage of Participants With At Least One Adverse Event (AE) Leading to Participant's Withdrawal From the Study | From first vaccination up to Day 393 | Withdrawal due to an AE will occur if the participant experiences an AE that requires early termination of treatment, because continued participation imposes an unacceptable risk to the participant's health or the participant is unwilling to continue because of the AE. |
| GMFR of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Days 8, 29, 36, 57, 211 and 393 | GMFR of anti-norovirus GII.4 VLP antibody titers measured by Pan-Ig ELISA are reported. The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level. |
| Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Days 8, 29, 36, 57, 211 and 393 | — |
| Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Days 8, 29, 36, 57, 211 and 393 | — |
| Geometric Mean Titer (GMT) GI.1 VLP Antibody Titers (HBGA) | Baseline (Day 1), Days 8, 29, 36, 57, 211 and 393 | GMT GI.1 VLP antibody titers measured by HBGA blocking assay are reported. |
| GMT of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Baseline (Day 1), Days 8, 29, 36, 57, 211 and 393 | GMT of anti-norovirus GII.4 VLP antibody titers measured by HBGA blocking assay are reported. |
| Geometric Mean Fold Rise (GMFR) of Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Days 8, 29, 36, 57, 211 and 393 | GMFR of anti-norovirus GI.1 VLP antibody titers measured by HBGA blocking assay are reported. The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level. |
| GMFR of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Days 8, 29, 36, 57, 211 and 393 | GMFR of anti-norovirus GII.4 VLP antibody titers measured by HBGA blocking assay are reported. The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level. |
| Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by Total Immunoglobulin-Enzyme-linked Immunosorbent Assay (Pan-Ig ELISA) | Days 8, 29, 36, 57, 211 and 393 | Percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 VLP and GII.4 VLP measured by Pan-Ig ELISA are reported. |
| Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Days 8, 29, 36, 57, 211 and 393 | Percentage of participants with a 4-Fold rise or greater in serum anti-norovirus GI.1 VLP antibody titers measured by Pan-Ig ELISA are reported. |
| Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Days 8, 29, 36, 57, 211 and 393 | Percentage of participants with a 4-fold rise or greater in serum anti-norovirus GII.4 VLP antibody titers measured by Pan-Ig ELISA are reported. |
Countries
United States
Participant flow
Recruitment details
Participants took part in the study at 10 investigative sites in United States from 1 February 2016 to 31 October 2017.
Pre-assignment details
Healthy elderly volunteers were enrolled and randomized in 1:1:1:1 ratio in 4 arm groups to receive either one or two doses of one of the 2 formulations (A or B) of norovirus (NoV) GI.1/GII4 bivalent virus like particle (VLP) vaccine or placebo. Healthy young adults received both placebo and formulation A.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1: NoV Vaccine Formulation A_1-Dose Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, intramuscularly (IM), on Day 1, followed by norovirus (NoV) GI.1 (15 μg)/GII.4 (50 μg) bivalent virus-like particle (VLP) vaccine (Formulation A), IM, on Day 29. | 76 |
| Arm 2: NoV Vaccine Formulation A_2-Dose Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Days 1 and 29. | 74 |
| Arm 3: NoV Vaccine Formulation B_1-Dose Participants ≥ 60 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg monophosphoryl lipid A (MPL) (Formulation B), IM, on Day 29. | 72 |
| Arm 4: NoV Vaccine Formulation B_2-Dose Participants ≥ 60 years of age, 2-dose regimen: Norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine with 15 μg MPL (Formulation B), IM, on Days 1 and 29. | 72 |
| Arm 5: NoV Vaccine Formulation A_1-Dose Participants 18 to 49 years of age, 1-dose regimen: Norovirus bivalent placebo-matching vaccine, IM, on Day 1, followed by norovirus GI.1 (15 μg)/GII.4 (50 μg) bivalent VLP vaccine (Formulation A), IM, on Day 29. | 26 |
| Total | 320 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Death | 1 | 1 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 | 2 |
| Overall Study | Reason not Specified | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | Arm 2: NoV Vaccine Formulation A_2-Dose | Arm 5: NoV Vaccine Formulation A_1-Dose | Arm 1: NoV Vaccine Formulation A_1-Dose | Total | Arm 4: NoV Vaccine Formulation B_2-Dose | Arm 3: NoV Vaccine Formulation B_1-Dose |
|---|---|---|---|---|---|---|
| Age, Continuous | 77.4 years STANDARD_DEVIATION 9.32 | 34.6 years STANDARD_DEVIATION 8.46 | 78.0 years STANDARD_DEVIATION 9.14 | 34.6 years STANDARD_DEVIATION 8.46 | 77.7 years STANDARD_DEVIATION 9.07 | 76.7 years STANDARD_DEVIATION 9.22 |
| Body Mass Index (BMI) | 26.28 kg/m^2 STANDARD_DEVIATION 3.958 | 27.22 kg/m^2 STANDARD_DEVIATION 4.481 | 27.01 kg/m^2 STANDARD_DEVIATION 3.554 | 26.76 kg/m^2 STANDARD_DEVIATION 3.833 | 26.46 kg/m^2 STANDARD_DEVIATION 3.909 | 27.29 kg/m^2 STANDARD_DEVIATION 3.899 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 2 Participants | 4 Participants | 19 Participants | 4 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 68 Participants | 24 Participants | 72 Participants | 301 Participants | 68 Participants | 69 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Height | 167.3 cm STANDARD_DEVIATION 9.52 | 169.4 cm STANDARD_DEVIATION 11.42 | 166.8 cm STANDARD_DEVIATION 9.95 | 167.3 cm STANDARD_DEVIATION 9.69 | 167.4 cm STANDARD_DEVIATION 10.26 | 168.0 cm STANDARD_DEVIATION 9.17 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants | 7 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 2 Participants | 2 Participants | 11 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 69 Participants | 20 Participants | 72 Participants | 299 Participants | 70 Participants | 68 Participants |
| Region of Enrollment United States | 74 Participants | 26 Participants | 76 Participants | 320 Participants | 72 Participants | 72 Participants |
| Sex: Female, Male Female | 41 Participants | 16 Participants | 44 Participants | 181 Participants | 40 Participants | 40 Participants |
| Sex: Female, Male Male | 33 Participants | 10 Participants | 32 Participants | 139 Participants | 32 Participants | 32 Participants |
| Weight | 73.76 kg STANDARD_DEVIATION 13.804 | 78.22 kg STANDARD_DEVIATION 15.357 | 75.56 kg STANDARD_DEVIATION 14.376 | 78.22 kg STANDARD_DEVIATION 15.357 | 74.34 kg STANDARD_DEVIATION 13.965 | 77.26 kg STANDARD_DEVIATION 14.404 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 76 | 1 / 74 | 0 / 72 | 1 / 72 | 0 / 25 |
| other Total, other adverse events | 28 / 76 | 25 / 74 | 23 / 72 | 21 / 72 | 7 / 25 |
| serious Total, serious adverse events | 7 / 76 | 9 / 74 | 17 / 72 | 9 / 72 | 0 / 25 |
Outcome results
Primary
Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 and GII.4 Virus Like Particles (VLP) as Measured by Histoblood Group Antigen (HBGA) Blocking Assay on Day 57
Time frame: Day 57
Population: Per Protocol Set (PPS) included all participants in the Full Analysis Set (FAS), who receive the planned vaccination \[both doses of vaccine, i.e. Norovirus (NoV) VLP vaccine or placebo\], and did not have major protocol violations. Overall number of participants analyzed is the number of participants with data available for analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 and GII.4 Virus Like Particles (VLP) as Measured by Histoblood Group Antigen (HBGA) Blocking Assay on Day 57 | 42.3 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 and GII.4 Virus Like Particles (VLP) as Measured by Histoblood Group Antigen (HBGA) Blocking Assay on Day 57 | 41.5 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 and GII.4 Virus Like Particles (VLP) as Measured by Histoblood Group Antigen (HBGA) Blocking Assay on Day 57 | 56.5 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 and GII.4 Virus Like Particles (VLP) as Measured by Histoblood Group Antigen (HBGA) Blocking Assay on Day 57 | 63.6 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 and GII.4 Virus Like Particles (VLP) as Measured by Histoblood Group Antigen (HBGA) Blocking Assay on Day 57 | 45.8 percentage of participants |
Primary
Percentage of Participants With At Least One Serious Adverse Event (SAE)
An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria.
Time frame: From first vaccination up to Day 393
Population: SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With At Least One Serious Adverse Event (SAE) | 9.2 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With At Least One Serious Adverse Event (SAE) | 12.2 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With At Least One Serious Adverse Event (SAE) | 23.6 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With At Least One Serious Adverse Event (SAE) | 12.5 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With At Least One Serious Adverse Event (SAE) | 0.0 percentage of participants |
Primary
Percentage of Participants With At Least One Unsolicited Adverse Event (AE) Within 28-days After First Vaccination on Day 1
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.
Time frame: Within 28 days of first vaccination on Day 1
Population: SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With At Least One Unsolicited Adverse Event (AE) Within 28-days After First Vaccination on Day 1 | 32.9 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With At Least One Unsolicited Adverse Event (AE) Within 28-days After First Vaccination on Day 1 | 28.4 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With At Least One Unsolicited Adverse Event (AE) Within 28-days After First Vaccination on Day 1 | 33.3 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With At Least One Unsolicited Adverse Event (AE) Within 28-days After First Vaccination on Day 1 | 26.4 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With At Least One Unsolicited Adverse Event (AE) Within 28-days After First Vaccination on Day 1 | 20.0 percentage of participants |
Primary
Percentage of Participants With At Least One Unsolicited Adverse Event (AE) Within 28-days After Second Vaccination on Day 29
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.
Time frame: Within 28 days of second vaccination on Day 29
Population: SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo). Overall number of participants analyzed is number of participants with data available for analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With At Least One Unsolicited Adverse Event (AE) Within 28-days After Second Vaccination on Day 29 | 34.2 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With At Least One Unsolicited Adverse Event (AE) Within 28-days After Second Vaccination on Day 29 | 18.8 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With At Least One Unsolicited Adverse Event (AE) Within 28-days After Second Vaccination on Day 29 | 25.0 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With At Least One Unsolicited Adverse Event (AE) Within 28-days After Second Vaccination on Day 29 | 30.3 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With At Least One Unsolicited Adverse Event (AE) Within 28-days After Second Vaccination on Day 29 | 8.3 percentage of participants |
Primary
Percentage of Participants With Elevated Body Temperature ≥38°C (Defined as Fever) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1
The body temperature measurement was performed using the thermometer for 7 days after each vaccination. The highest body temperature observed each day was recorded on the diary card. An elevated temperature is ≥ 38 °C or 100.4°F (considered as fever).
Time frame: Within 7 days of first vaccination on Day 1
Population: SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo). Overall number of participants analyzed is the number of participants with data available for analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Elevated Body Temperature ≥38°C (Defined as Fever) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | 0.0 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With Elevated Body Temperature ≥38°C (Defined as Fever) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | 0.0 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With Elevated Body Temperature ≥38°C (Defined as Fever) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | 0.0 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With Elevated Body Temperature ≥38°C (Defined as Fever) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | 0.0 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Elevated Body Temperature ≥38°C (Defined as Fever) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | 0.0 percentage of participants |
Primary
Percentage of Participants With Elevated Body Temperature ≥38°C (Defined as Fever) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29
The body temperature measurement was performed using the thermometer for 7 days after each vaccination. The highest body temperature observed each day was recorded on the diary card. An elevated temperature is ≥ 38 °C or 100.4°F (considered as fever).
Time frame: Within 7 days of second vaccination on Day 29
Population: SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo). Overall number of participants analyzed is the number of participants with data available for analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Elevated Body Temperature ≥38°C (Defined as Fever) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | 0.0 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With Elevated Body Temperature ≥38°C (Defined as Fever) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | 0.0 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With Elevated Body Temperature ≥38°C (Defined as Fever) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | 0.0 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With Elevated Body Temperature ≥38°C (Defined as Fever) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | 1.5 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Elevated Body Temperature ≥38°C (Defined as Fever) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | 0.0 percentage of participants |
Primary
Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1
Solicited local AEs at the injection site that occurred within 7 days after each vaccination were collected using a diary and included pain, erythema swelling and induration.
Time frame: Within 7 days of first vaccination on Day 1
Population: Safety Analysis Set (SAF) included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo). Number analyzed is the number of participants with evaluable data for the specific category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Swelling | 0.0 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Induration | 0.0 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Any Solicited Local AEs | 6.6 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Pain | 5.3 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Erythema | 1.3 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Swelling | 2.7 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Erythema | 2.7 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Pain | 23.3 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Any Solicited Local AEs | 26.0 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Induration | 1.4 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Any Solicited Local AEs | 15.3 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Pain | 9.7 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Erythema | 4.2 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Swelling | 2.8 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Induration | 1.4 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Any Solicited Local AEs | 34.7 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Induration | 1.4 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Swelling | 1.4 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Erythema | 1.4 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Pain | 34.7 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Erythema | 4.0 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Any Solicited Local AEs | 4.0 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Swelling | 0.0 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Induration | 0.0 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Pain | 4.0 percentage of participants |
Primary
Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29
Solicited local AEs at the injection site that occurred within 7 days after each vaccination were collected using a diary and included pain, erythema, swelling and induration.
Time frame: Within 7 days of second vaccination on Day 29
Population: SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo). Overall number of participants analyzed is the number of participants with data available for analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Swelling | 1.4 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Any Solicited Local AEs | 37.0 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Induration | 1.4 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Pain | 32.9 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Erythema | 2.7 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Swelling | 0.0 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Erythema | 0.0 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Pain | 21.7 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Induration | 0.0 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Any Solicited Local AEs | 21.7 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Erythema | 1.5 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Any Solicited Local AEs | 38.2 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Pain | 38.2 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Swelling | 1.5 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Induration | 1.5 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Induration | 1.5 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Any Solicited Local AEs | 39.4 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Swelling | 1.5 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Erythema | 3.0 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Pain | 37.9 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Erythema | 0.0 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Swelling | 0.0 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Any Solicited Local AEs | 41.7 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Induration | 0.0 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Pain | 41.7 percentage of participants |
Primary
Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1
Solicited systemic AEs that occurred within 7 days after each vaccination were collected using a diary and included headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea.
Time frame: Within 7 days of first vaccination on Day 1
Population: SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo). Number analyzed is the number of participants with evaluable data for the specific category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Myalgia | 5.3 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Any solicited systemic AEs | 28.9 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Diarrhea | 5.3 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Vomiting | 0.0 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Headache | 7.9 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Arthralgia | 5.3 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Fatigue | 18.4 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Headache | 2.7 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Fatigue | 24.7 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Any solicited systemic AEs | 34.2 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Arthralgia | 8.2 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Myalgia | 13.7 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Vomiting | 1.4 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Diarrhea | 6.8 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Vomiting | 0.0 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Diarrhea | 8.3 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Any solicited systemic AEs | 30.6 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Headache | 11.1 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Fatigue | 9.7 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Myalgia | 11.1 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Arthralgia | 6.9 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Fatigue | 27.8 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Headache | 12.5 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Arthralgia | 6.9 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Vomiting | 2.8 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Any solicited systemic AEs | 44.4 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Diarrhea | 18.1 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Myalgia | 20.8 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Diarrhea | 8.0 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Arthralgia | 4.0 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Any solicited systemic AEs | 36.0 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Headache | 20.0 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Myalgia | 16.0 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Vomiting | 0.0 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1 | Fatigue | 28.0 percentage of participants |
Primary
Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29
Solicited systemic AEs that occurred within 7 days after each vaccination were collected using a diary and included headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea.
Time frame: Within 7 days of second vaccination on Day 29
Population: SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo). Overall number of participants analyzed is the number of participants with data available for analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Any solicited systemic AEs | 19.2 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Diarrhea | 1.4 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Vomiting | 0.0 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Fatigue | 12.3 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Headache | 8.2 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Myalgia | 6.8 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Arthralgia | 4.1 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Arthralgia | 7.2 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Myalgia | 5.8 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Headache | 5.8 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Any solicited systemic AEs | 20.3 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Vomiting | 0.0 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Fatigue | 15.9 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Diarrhea | 4.3 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Myalgia | 7.4 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Any solicited systemic AEs | 20.6 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Headache | 5.9 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Fatigue | 13.2 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Arthralgia | 4.4 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Vomiting | 0.0 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Diarrhea | 2.9 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Fatigue | 15.2 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Arthralgia | 6.1 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Headache | 6.1 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Diarrhea | 4.5 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Vomiting | 1.5 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Any solicited systemic AEs | 28.8 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Myalgia | 13.6 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Fatigue | 8.3 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Diarrhea | 0.0 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Vomiting | 0.0 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Arthralgia | 4.2 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Headache | 4.2 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Any solicited systemic AEs | 16.7 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29 | Myalgia | 4.2 percentage of participants |
Secondary
Geometric Mean Fold Rise (GMFR) of Anti-norovirus GI.1 VLP Antibody Titers (HBGA)
GMFR of anti-norovirus GI.1 VLP antibody titers measured by HBGA blocking assay are reported. The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level.
Time frame: Days 8, 29, 36, 57, 211 and 393
Population: PPS included all participants in the FAS, who received the planned vaccination (both doses of vaccine, i.e. NoV VLP vaccine or placebo), and did not have major protocol violations. Number analyzed is the number of participants with evaluable data at the given time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Arm 1: NoV Vaccine Formulation A_1-Dose | Geometric Mean Fold Rise (GMFR) of Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 8 | 1.0 ratio |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Geometric Mean Fold Rise (GMFR) of Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 393 | 2.4 ratio |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Geometric Mean Fold Rise (GMFR) of Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 36 | 7.3 ratio |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Geometric Mean Fold Rise (GMFR) of Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 29 | 1.0 ratio |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Geometric Mean Fold Rise (GMFR) of Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 57 | 6.6 ratio |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Geometric Mean Fold Rise (GMFR) of Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 211 | 3.2 ratio |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Geometric Mean Fold Rise (GMFR) of Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 36 | 12.6 ratio |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Geometric Mean Fold Rise (GMFR) of Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 57 | 12.1 ratio |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Geometric Mean Fold Rise (GMFR) of Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 8 | 10.1 ratio |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Geometric Mean Fold Rise (GMFR) of Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 29 | 13.0 ratio |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Geometric Mean Fold Rise (GMFR) of Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 211 | 5.5 ratio |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Geometric Mean Fold Rise (GMFR) of Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 393 | 3.9 ratio |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Geometric Mean Fold Rise (GMFR) of Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 36 | 10.6 ratio |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Geometric Mean Fold Rise (GMFR) of Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 211 | 4.8 ratio |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Geometric Mean Fold Rise (GMFR) of Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 57 | 10.0 ratio |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Geometric Mean Fold Rise (GMFR) of Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 393 | 3.2 ratio |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Geometric Mean Fold Rise (GMFR) of Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 29 | 1.0 ratio |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Geometric Mean Fold Rise (GMFR) of Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 8 | 1.0 ratio |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Geometric Mean Fold Rise (GMFR) of Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 57 | 13.3 ratio |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Geometric Mean Fold Rise (GMFR) of Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 29 | 12.0 ratio |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Geometric Mean Fold Rise (GMFR) of Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 36 | 14.2 ratio |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Geometric Mean Fold Rise (GMFR) of Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 8 | 14.1 ratio |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Geometric Mean Fold Rise (GMFR) of Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 393 | 3.5 ratio |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Geometric Mean Fold Rise (GMFR) of Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 211 | 5.3 ratio |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Geometric Mean Fold Rise (GMFR) of Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 393 | 1.8 ratio |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Geometric Mean Fold Rise (GMFR) of Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 36 | 7.5 ratio |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Geometric Mean Fold Rise (GMFR) of Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 211 | 2.4 ratio |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Geometric Mean Fold Rise (GMFR) of Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 8 | 1.0 ratio |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Geometric Mean Fold Rise (GMFR) of Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 57 | 5.3 ratio |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Geometric Mean Fold Rise (GMFR) of Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 29 | 1.0 ratio |
Secondary
Geometric Mean Titer (GMT) GI.1 VLP Antibody Titers (HBGA)
GMT GI.1 VLP antibody titers measured by HBGA blocking assay are reported.
Time frame: Baseline (Day 1), Days 8, 29, 36, 57, 211 and 393
Population: PPS included all participants in the FAS, who received the planned vaccination (both doses of vaccine, i.e. NoV VLP vaccine or placebo), and did not have major protocol violations. Number analyzed is the number of participants with evaluable data at the given time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Arm 1: NoV Vaccine Formulation A_1-Dose | Geometric Mean Titer (GMT) GI.1 VLP Antibody Titers (HBGA) | Day 211 | 81.8 titer |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Geometric Mean Titer (GMT) GI.1 VLP Antibody Titers (HBGA) | Day 8 | 26.6 titer |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Geometric Mean Titer (GMT) GI.1 VLP Antibody Titers (HBGA) | Day 393 | 60.2 titer |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Geometric Mean Titer (GMT) GI.1 VLP Antibody Titers (HBGA) | Day 57 | 177.0 titer |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Geometric Mean Titer (GMT) GI.1 VLP Antibody Titers (HBGA) | Day 36 | 194.2 titer |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Geometric Mean Titer (GMT) GI.1 VLP Antibody Titers (HBGA) | Day 29 | 26.2 titer |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Geometric Mean Titer (GMT) GI.1 VLP Antibody Titers (HBGA) | Baseline (Day 1) | 26.5 titer |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Geometric Mean Titer (GMT) GI.1 VLP Antibody Titers (HBGA) | Day 393 | 112.2 titer |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Geometric Mean Titer (GMT) GI.1 VLP Antibody Titers (HBGA) | Baseline (Day 1) | 29.0 titer |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Geometric Mean Titer (GMT) GI.1 VLP Antibody Titers (HBGA) | Day 8 | 282.4 titer |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Geometric Mean Titer (GMT) GI.1 VLP Antibody Titers (HBGA) | Day 29 | 373.6 titer |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Geometric Mean Titer (GMT) GI.1 VLP Antibody Titers (HBGA) | Day 36 | 361.1 titer |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Geometric Mean Titer (GMT) GI.1 VLP Antibody Titers (HBGA) | Day 57 | 353.6 titer |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Geometric Mean Titer (GMT) GI.1 VLP Antibody Titers (HBGA) | Day 211 | 160.5 titer |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Geometric Mean Titer (GMT) GI.1 VLP Antibody Titers (HBGA) | Baseline (Day 1) | 26.7 titer |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Geometric Mean Titer (GMT) GI.1 VLP Antibody Titers (HBGA) | Day 57 | 262.2 titer |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Geometric Mean Titer (GMT) GI.1 VLP Antibody Titers (HBGA) | Day 36 | 280.1 titer |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Geometric Mean Titer (GMT) GI.1 VLP Antibody Titers (HBGA) | Day 29 | 27.3 titer |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Geometric Mean Titer (GMT) GI.1 VLP Antibody Titers (HBGA) | Day 393 | 85.7 titer |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Geometric Mean Titer (GMT) GI.1 VLP Antibody Titers (HBGA) | Day 8 | 26.5 titer |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Geometric Mean Titer (GMT) GI.1 VLP Antibody Titers (HBGA) | Day 211 | 128.3 titer |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Geometric Mean Titer (GMT) GI.1 VLP Antibody Titers (HBGA) | Day 36 | 338.9 titer |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Geometric Mean Titer (GMT) GI.1 VLP Antibody Titers (HBGA) | Day 29 | 285.5 titer |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Geometric Mean Titer (GMT) GI.1 VLP Antibody Titers (HBGA) | Day 393 | 84.6 titer |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Geometric Mean Titer (GMT) GI.1 VLP Antibody Titers (HBGA) | Day 211 | 126.7 titer |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Geometric Mean Titer (GMT) GI.1 VLP Antibody Titers (HBGA) | Day 8 | 332.3 titer |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Geometric Mean Titer (GMT) GI.1 VLP Antibody Titers (HBGA) | Day 57 | 317.1 titer |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Geometric Mean Titer (GMT) GI.1 VLP Antibody Titers (HBGA) | Baseline (Day 1) | 23.9 titer |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Geometric Mean Titer (GMT) GI.1 VLP Antibody Titers (HBGA) | Day 211 | 54.1 titer |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Geometric Mean Titer (GMT) GI.1 VLP Antibody Titers (HBGA) | Day 57 | 117.7 titer |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Geometric Mean Titer (GMT) GI.1 VLP Antibody Titers (HBGA) | Day 8 | 21.7 titer |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Geometric Mean Titer (GMT) GI.1 VLP Antibody Titers (HBGA) | Baseline (Day 1) | 22.0 titer |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Geometric Mean Titer (GMT) GI.1 VLP Antibody Titers (HBGA) | Day 393 | 41.0 titer |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Geometric Mean Titer (GMT) GI.1 VLP Antibody Titers (HBGA) | Day 36 | 150.8 titer |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Geometric Mean Titer (GMT) GI.1 VLP Antibody Titers (HBGA) | Day 29 | 21.7 titer |
Secondary
GMFR of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA)
GMFR of anti-norovirus GI.1 VLP antibody titers measured by Pan-Ig ELISA are reported. The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level.
Time frame: Days 8, 29, 36, 57, 211 and 393
Population: PPS included all participants in the FAS, who received the planned vaccination (both doses of vaccine, i.e. NoV VLP vaccine or placebo), and did not have major protocol violations. Number analyzed is the number of participants with evaluable data at the given time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Arm 1: NoV Vaccine Formulation A_1-Dose | GMFR of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 8 | 1.0 ratio |
| Arm 1: NoV Vaccine Formulation A_1-Dose | GMFR of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 57 | 9.0 ratio |
| Arm 1: NoV Vaccine Formulation A_1-Dose | GMFR of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 29 | 1.0 ratio |
| Arm 1: NoV Vaccine Formulation A_1-Dose | GMFR of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 36 | 6.3 ratio |
| Arm 1: NoV Vaccine Formulation A_1-Dose | GMFR of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 393 | 4.4 ratio |
| Arm 1: NoV Vaccine Formulation A_1-Dose | GMFR of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 211 | 6.0 ratio |
| Arm 2: NoV Vaccine Formulation A_2-Dose | GMFR of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 36 | 8.5 ratio |
| Arm 2: NoV Vaccine Formulation A_2-Dose | GMFR of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 57 | 7.9 ratio |
| Arm 2: NoV Vaccine Formulation A_2-Dose | GMFR of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 8 | 5.1 ratio |
| Arm 2: NoV Vaccine Formulation A_2-Dose | GMFR of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 393 | 4.0 ratio |
| Arm 2: NoV Vaccine Formulation A_2-Dose | GMFR of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 211 | 5.8 ratio |
| Arm 2: NoV Vaccine Formulation A_2-Dose | GMFR of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 29 | 8.5 ratio |
| Arm 3: NoV Vaccine Formulation B_1-Dose | GMFR of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 36 | 7.6 ratio |
| Arm 3: NoV Vaccine Formulation B_1-Dose | GMFR of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 29 | 0.9 ratio |
| Arm 3: NoV Vaccine Formulation B_1-Dose | GMFR of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 393 | 4.6 ratio |
| Arm 3: NoV Vaccine Formulation B_1-Dose | GMFR of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 211 | 6.4 ratio |
| Arm 3: NoV Vaccine Formulation B_1-Dose | GMFR of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 57 | 11.4 ratio |
| Arm 3: NoV Vaccine Formulation B_1-Dose | GMFR of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 8 | 1.0 ratio |
| Arm 4: NoV Vaccine Formulation B_2-Dose | GMFR of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 36 | 14.8 ratio |
| Arm 4: NoV Vaccine Formulation B_2-Dose | GMFR of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 393 | 5.2 ratio |
| Arm 4: NoV Vaccine Formulation B_2-Dose | GMFR of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 8 | 10.3 ratio |
| Arm 4: NoV Vaccine Formulation B_2-Dose | GMFR of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 29 | 14.4 ratio |
| Arm 4: NoV Vaccine Formulation B_2-Dose | GMFR of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 57 | 13.2 ratio |
| Arm 4: NoV Vaccine Formulation B_2-Dose | GMFR of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 211 | 7.9 ratio |
| Arm 5: NoV Vaccine Formulation A_1-Dose | GMFR of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 29 | 1.2 ratio |
| Arm 5: NoV Vaccine Formulation A_1-Dose | GMFR of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 8 | 1.0 ratio |
| Arm 5: NoV Vaccine Formulation A_1-Dose | GMFR of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 393 | 5.1 ratio |
| Arm 5: NoV Vaccine Formulation A_1-Dose | GMFR of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 36 | 17.3 ratio |
| Arm 5: NoV Vaccine Formulation A_1-Dose | GMFR of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 211 | 8.0 ratio |
| Arm 5: NoV Vaccine Formulation A_1-Dose | GMFR of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 57 | 17.7 ratio |
Secondary
GMFR of Anti-norovirus GII.4 VLP Antibody Titers (HBGA)
GMFR of anti-norovirus GII.4 VLP antibody titers measured by HBGA blocking assay are reported. The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level.
Time frame: Days 8, 29, 36, 57, 211 and 393
Population: PPS included all participants in the FAS, who received the planned vaccination (both doses of vaccine, i.e. NoV VLP vaccine or placebo), and did not have major protocol violations. Number analyzed is the number of participants with evaluable data at the given time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Arm 1: NoV Vaccine Formulation A_1-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 29 | 0.9 ratio |
| Arm 1: NoV Vaccine Formulation A_1-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 211 | 3.4 ratio |
| Arm 1: NoV Vaccine Formulation A_1-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 8 | 0.9 ratio |
| Arm 1: NoV Vaccine Formulation A_1-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 57 | 8.1 ratio |
| Arm 1: NoV Vaccine Formulation A_1-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 393 | 3.0 ratio |
| Arm 1: NoV Vaccine Formulation A_1-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 36 | 8.4 ratio |
| Arm 2: NoV Vaccine Formulation A_2-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 36 | 7.5 ratio |
| Arm 2: NoV Vaccine Formulation A_2-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 29 | 7.9 ratio |
| Arm 2: NoV Vaccine Formulation A_2-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 393 | 2.6 ratio |
| Arm 2: NoV Vaccine Formulation A_2-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 57 | 5.8 ratio |
| Arm 2: NoV Vaccine Formulation A_2-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 211 | 3.0 ratio |
| Arm 2: NoV Vaccine Formulation A_2-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 8 | 6.9 ratio |
| Arm 3: NoV Vaccine Formulation B_1-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 29 | 0.8 ratio |
| Arm 3: NoV Vaccine Formulation B_1-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 57 | 8.4 ratio |
| Arm 3: NoV Vaccine Formulation B_1-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 393 | 2.7 ratio |
| Arm 3: NoV Vaccine Formulation B_1-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 8 | 0.9 ratio |
| Arm 3: NoV Vaccine Formulation B_1-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 36 | 7.3 ratio |
| Arm 3: NoV Vaccine Formulation B_1-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 211 | 3.4 ratio |
| Arm 4: NoV Vaccine Formulation B_2-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 211 | 3.7 ratio |
| Arm 4: NoV Vaccine Formulation B_2-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 36 | 9.3 ratio |
| Arm 4: NoV Vaccine Formulation B_2-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 393 | 3.2 ratio |
| Arm 4: NoV Vaccine Formulation B_2-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 8 | 11.6 ratio |
| Arm 4: NoV Vaccine Formulation B_2-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 29 | 10.2 ratio |
| Arm 4: NoV Vaccine Formulation B_2-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 57 | 7.1 ratio |
| Arm 5: NoV Vaccine Formulation A_1-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 29 | 0.9 ratio |
| Arm 5: NoV Vaccine Formulation A_1-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 36 | 15.1 ratio |
| Arm 5: NoV Vaccine Formulation A_1-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 57 | 9.4 ratio |
| Arm 5: NoV Vaccine Formulation A_1-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 393 | 3.0 ratio |
| Arm 5: NoV Vaccine Formulation A_1-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 211 | 3.8 ratio |
| Arm 5: NoV Vaccine Formulation A_1-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 8 | 0.9 ratio |
Secondary
GMFR of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA)
GMFR of anti-norovirus GII.4 VLP antibody titers measured by Pan-Ig ELISA are reported. The fold rise was calculated as the ratio of the post-vaccination titer level to the pre-vaccination titer level.
Time frame: Days 8, 29, 36, 57, 211 and 393
Population: PPS included all participants in the FAS, who received the planned vaccination (both doses of vaccine, i.e. NoV VLP vaccine or placebo), and did not have major protocol violations. Number analyzed is the number of participants with evaluable data at the given time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Arm 1: NoV Vaccine Formulation A_1-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 36 | 6.0 ratio |
| Arm 1: NoV Vaccine Formulation A_1-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 393 | 3.1 ratio |
| Arm 1: NoV Vaccine Formulation A_1-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 57 | 8.7 ratio |
| Arm 1: NoV Vaccine Formulation A_1-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 8 | 1.0 ratio |
| Arm 1: NoV Vaccine Formulation A_1-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 29 | 1.0 ratio |
| Arm 1: NoV Vaccine Formulation A_1-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 211 | 4.9 ratio |
| Arm 2: NoV Vaccine Formulation A_2-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 8 | 4.5 ratio |
| Arm 2: NoV Vaccine Formulation A_2-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 29 | 7.7 ratio |
| Arm 2: NoV Vaccine Formulation A_2-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 57 | 6.9 ratio |
| Arm 2: NoV Vaccine Formulation A_2-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 211 | 4.6 ratio |
| Arm 2: NoV Vaccine Formulation A_2-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 393 | 3.1 ratio |
| Arm 2: NoV Vaccine Formulation A_2-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 36 | 7.5 ratio |
| Arm 3: NoV Vaccine Formulation B_1-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 211 | 4.5 ratio |
| Arm 3: NoV Vaccine Formulation B_1-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 393 | 2.6 ratio |
| Arm 3: NoV Vaccine Formulation B_1-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 29 | 1.0 ratio |
| Arm 3: NoV Vaccine Formulation B_1-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 36 | 5.0 ratio |
| Arm 3: NoV Vaccine Formulation B_1-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 8 | 1.0 ratio |
| Arm 3: NoV Vaccine Formulation B_1-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 57 | 8.3 ratio |
| Arm 4: NoV Vaccine Formulation B_2-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 211 | 5.0 ratio |
| Arm 4: NoV Vaccine Formulation B_2-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 57 | 7.8 ratio |
| Arm 4: NoV Vaccine Formulation B_2-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 8 | 6.3 ratio |
| Arm 4: NoV Vaccine Formulation B_2-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 29 | 9.3 ratio |
| Arm 4: NoV Vaccine Formulation B_2-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 393 | 3.0 ratio |
| Arm 4: NoV Vaccine Formulation B_2-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 36 | 8.9 ratio |
| Arm 5: NoV Vaccine Formulation A_1-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 393 | 3.1 ratio |
| Arm 5: NoV Vaccine Formulation A_1-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 8 | 1.0 ratio |
| Arm 5: NoV Vaccine Formulation A_1-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 29 | 1.0 ratio |
| Arm 5: NoV Vaccine Formulation A_1-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 36 | 9.6 ratio |
| Arm 5: NoV Vaccine Formulation A_1-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 57 | 9.3 ratio |
| Arm 5: NoV Vaccine Formulation A_1-Dose | GMFR of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 211 | 4.7 ratio |
Secondary
GMT of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA)
GMT of anti-norovirus GI.1 VLP antibody titers measured by Pan-Ig ELISA are reported.
Time frame: Baseline (Day 1), Days 8, 29, 36, 57, 211 and 393
Population: PPS included all participants in the FAS, who received the planned vaccination (both doses of vaccine, i.e. NoV VLP vaccine or placebo), and did not have major protocol violations. Number analyzed is the number of participants with evaluable data at the given time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Arm 1: NoV Vaccine Formulation A_1-Dose | GMT of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 29 | 668.2 titer |
| Arm 1: NoV Vaccine Formulation A_1-Dose | GMT of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 57 | 6183.5 titer |
| Arm 1: NoV Vaccine Formulation A_1-Dose | GMT of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 36 | 4158.6 titer |
| Arm 1: NoV Vaccine Formulation A_1-Dose | GMT of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 211 | 3945.2 titer |
| Arm 1: NoV Vaccine Formulation A_1-Dose | GMT of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Baseline (Day 1) | 661.8 titer |
| Arm 1: NoV Vaccine Formulation A_1-Dose | GMT of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 393 | 2903.4 titer |
| Arm 1: NoV Vaccine Formulation A_1-Dose | GMT of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 8 | 678.0 titer |
| Arm 2: NoV Vaccine Formulation A_2-Dose | GMT of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 57 | 7235.1 titer |
| Arm 2: NoV Vaccine Formulation A_2-Dose | GMT of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 393 | 3672.1 titer |
| Arm 2: NoV Vaccine Formulation A_2-Dose | GMT of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 8 | 4534.9 titer |
| Arm 2: NoV Vaccine Formulation A_2-Dose | GMT of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 211 | 5161.2 titer |
| Arm 2: NoV Vaccine Formulation A_2-Dose | GMT of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Baseline (Day 1) | 906.1 titer |
| Arm 2: NoV Vaccine Formulation A_2-Dose | GMT of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 29 | 7701.1 titer |
| Arm 2: NoV Vaccine Formulation A_2-Dose | GMT of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 36 | 7663.6 titer |
| Arm 3: NoV Vaccine Formulation B_1-Dose | GMT of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 57 | 8838.3 titer |
| Arm 3: NoV Vaccine Formulation B_1-Dose | GMT of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Baseline (Day 1) | 838.5 titer |
| Arm 3: NoV Vaccine Formulation B_1-Dose | GMT of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 36 | 6411.8 titer |
| Arm 3: NoV Vaccine Formulation B_1-Dose | GMT of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 29 | 791.9 titer |
| Arm 3: NoV Vaccine Formulation B_1-Dose | GMT of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 393 | 3862.9 titer |
| Arm 3: NoV Vaccine Formulation B_1-Dose | GMT of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 211 | 5406.6 titer |
| Arm 3: NoV Vaccine Formulation B_1-Dose | GMT of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 8 | 829.4 titer |
| Arm 4: NoV Vaccine Formulation B_2-Dose | GMT of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Baseline (Day 1) | 619.7 titer |
| Arm 4: NoV Vaccine Formulation B_2-Dose | GMT of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 36 | 9161.1 titer |
| Arm 4: NoV Vaccine Formulation B_2-Dose | GMT of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 57 | 8182.2 titer |
| Arm 4: NoV Vaccine Formulation B_2-Dose | GMT of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 211 | 4882.3 titer |
| Arm 4: NoV Vaccine Formulation B_2-Dose | GMT of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 8 | 6382.8 titer |
| Arm 4: NoV Vaccine Formulation B_2-Dose | GMT of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 29 | 8951.5 titer |
| Arm 4: NoV Vaccine Formulation B_2-Dose | GMT of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 393 | 3370.0 titer |
| Arm 5: NoV Vaccine Formulation A_1-Dose | GMT of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 8 | 455.2 titer |
| Arm 5: NoV Vaccine Formulation A_1-Dose | GMT of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 211 | 3523.2 titer |
| Arm 5: NoV Vaccine Formulation A_1-Dose | GMT of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Baseline (Day 1) | 460.3 titer |
| Arm 5: NoV Vaccine Formulation A_1-Dose | GMT of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 57 | 8165.5 titer |
| Arm 5: NoV Vaccine Formulation A_1-Dose | GMT of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 36 | 7603.5 titer |
| Arm 5: NoV Vaccine Formulation A_1-Dose | GMT of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 393 | 2252.6 titer |
| Arm 5: NoV Vaccine Formulation A_1-Dose | GMT of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 29 | 574.0 titer |
Secondary
GMT of Anti-norovirus GII.4 VLP Antibody Titers (HBGA)
GMT of anti-norovirus GII.4 VLP antibody titers measured by HBGA blocking assay are reported.
Time frame: Baseline (Day 1), Days 8, 29, 36, 57, 211 and 393
Population: PPS included all participants in the FAS, who received the planned vaccination (both doses of vaccine, i.e. NoV VLP vaccine or placebo), and did not have major protocol violations. Number analyzed is the number of participants with evaluable data at the given time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Arm 1: NoV Vaccine Formulation A_1-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 29 | 58.6 titer |
| Arm 1: NoV Vaccine Formulation A_1-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 57 | 528.0 titer |
| Arm 1: NoV Vaccine Formulation A_1-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 8 | 60.7 titer |
| Arm 1: NoV Vaccine Formulation A_1-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 393 | 188.9 titer |
| Arm 1: NoV Vaccine Formulation A_1-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Baseline (Day 1) | 66.5 titer |
| Arm 1: NoV Vaccine Formulation A_1-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 36 | 556.5 titer |
| Arm 1: NoV Vaccine Formulation A_1-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 211 | 222.0 titer |
| Arm 2: NoV Vaccine Formulation A_2-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 36 | 757.1 titer |
| Arm 2: NoV Vaccine Formulation A_2-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 57 | 600.6 titer |
| Arm 2: NoV Vaccine Formulation A_2-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 393 | 249.8 titer |
| Arm 2: NoV Vaccine Formulation A_2-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 29 | 787.7 titer |
| Arm 2: NoV Vaccine Formulation A_2-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Baseline (Day 1) | 100.3 titer |
| Arm 2: NoV Vaccine Formulation A_2-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 211 | 298.9 titer |
| Arm 2: NoV Vaccine Formulation A_2-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 8 | 694.9 titer |
| Arm 3: NoV Vaccine Formulation B_1-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Baseline (Day 1) | 99.5 titer |
| Arm 3: NoV Vaccine Formulation B_1-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 8 | 94.1 titer |
| Arm 3: NoV Vaccine Formulation B_1-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 29 | 82.8 titer |
| Arm 3: NoV Vaccine Formulation B_1-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 36 | 733.8 titer |
| Arm 3: NoV Vaccine Formulation B_1-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 57 | 790.8 titer |
| Arm 3: NoV Vaccine Formulation B_1-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 393 | 265.9 titer |
| Arm 3: NoV Vaccine Formulation B_1-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 211 | 318.6 titer |
| Arm 4: NoV Vaccine Formulation B_2-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 57 | 613.6 titer |
| Arm 4: NoV Vaccine Formulation B_2-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 36 | 799.4 titer |
| Arm 4: NoV Vaccine Formulation B_2-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 29 | 876.1 titer |
| Arm 4: NoV Vaccine Formulation B_2-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 393 | 278.9 titer |
| Arm 4: NoV Vaccine Formulation B_2-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 8 | 994.9 titer |
| Arm 4: NoV Vaccine Formulation B_2-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Baseline (Day 1) | 86.1 titer |
| Arm 4: NoV Vaccine Formulation B_2-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 211 | 315.9 titer |
| Arm 5: NoV Vaccine Formulation A_1-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 36 | 1234.5 titer |
| Arm 5: NoV Vaccine Formulation A_1-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Baseline (Day 1) | 78.7 titer |
| Arm 5: NoV Vaccine Formulation A_1-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 29 | 67.2 titer |
| Arm 5: NoV Vaccine Formulation A_1-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 211 | 280.3 titer |
| Arm 5: NoV Vaccine Formulation A_1-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 57 | 742.0 titer |
| Arm 5: NoV Vaccine Formulation A_1-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 8 | 75.2 titer |
| Arm 5: NoV Vaccine Formulation A_1-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 393 | 223.4 titer |
Secondary
GMT of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA)
GMT of anti-norovirus GII.4 VLP antibody titers measured by Pan-Ig ELISA are reported.
Time frame: Baseline (Day 1), Days 8, 29, 36, 57, 211 and 393
Population: PPS included all participants in the FAS, who received the planned vaccination (both doses of vaccine, i.e. NoV VLP vaccine or placebo), and did not have major protocol violations. Number analyzed is the number of participants with evaluable data at the given time point.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Arm 1: NoV Vaccine Formulation A_1-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 211 | 3702.0 titer |
| Arm 1: NoV Vaccine Formulation A_1-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 29 | 766.8 titer |
| Arm 1: NoV Vaccine Formulation A_1-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 57 | 6564.1 titer |
| Arm 1: NoV Vaccine Formulation A_1-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 393 | 2216.7 titer |
| Arm 1: NoV Vaccine Formulation A_1-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 36 | 4587.6 titer |
| Arm 1: NoV Vaccine Formulation A_1-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Baseline (Day 1) | 761.9 titer |
| Arm 1: NoV Vaccine Formulation A_1-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 8 | 766.6 titer |
| Arm 2: NoV Vaccine Formulation A_2-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 393 | 3151.5 titer |
| Arm 2: NoV Vaccine Formulation A_2-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Baseline (Day 1) | 1054.9 titer |
| Arm 2: NoV Vaccine Formulation A_2-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 36 | 7911.9 titer |
| Arm 2: NoV Vaccine Formulation A_2-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 57 | 7489.2 titer |
| Arm 2: NoV Vaccine Formulation A_2-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 8 | 4725.5 titer |
| Arm 2: NoV Vaccine Formulation A_2-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 211 | 4915.8 titer |
| Arm 2: NoV Vaccine Formulation A_2-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 29 | 8105.1 titer |
| Arm 3: NoV Vaccine Formulation B_1-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 29 | 1017.7 titer |
| Arm 3: NoV Vaccine Formulation B_1-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Baseline (Day 1) | 1066.3 titer |
| Arm 3: NoV Vaccine Formulation B_1-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 211 | 4657.8 titer |
| Arm 3: NoV Vaccine Formulation B_1-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 393 | 2807.4 titer |
| Arm 3: NoV Vaccine Formulation B_1-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 57 | 7877.2 titer |
| Arm 3: NoV Vaccine Formulation B_1-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 8 | 1078.9 titer |
| Arm 3: NoV Vaccine Formulation B_1-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 36 | 5411.9 titer |
| Arm 4: NoV Vaccine Formulation B_2-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 8 | 5691.9 titer |
| Arm 4: NoV Vaccine Formulation B_2-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 36 | 8025.5 titer |
| Arm 4: NoV Vaccine Formulation B_2-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 57 | 7028.4 titer |
| Arm 4: NoV Vaccine Formulation B_2-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 211 | 4456.2 titer |
| Arm 4: NoV Vaccine Formulation B_2-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Baseline (Day 1) | 897.4 titer |
| Arm 4: NoV Vaccine Formulation B_2-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 29 | 8314.1 titer |
| Arm 4: NoV Vaccine Formulation B_2-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 393 | 2853.9 titer |
| Arm 5: NoV Vaccine Formulation A_1-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 57 | 9507.3 titer |
| Arm 5: NoV Vaccine Formulation A_1-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 36 | 10084.9 titer |
| Arm 5: NoV Vaccine Formulation A_1-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 8 | 1054.6 titer |
| Arm 5: NoV Vaccine Formulation A_1-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 393 | 2969.5 titer |
| Arm 5: NoV Vaccine Formulation A_1-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 29 | 1022.4 titer |
| Arm 5: NoV Vaccine Formulation A_1-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Baseline (Day 1) | 1023.2 titer |
| Arm 5: NoV Vaccine Formulation A_1-Dose | GMT of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 211 | 4531.5 titer |
Secondary
Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by HBGA Blocking Assay
Time frame: Days 8, 29, 36, 211 and 393
Population: PPS included all participants in the FAS, who received the planned vaccination (both doses of vaccine, i.e. NoV VLP vaccine or placebo), and did not have major protocol violations. Number analyzed is the number of participants with evaluable data at the given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by HBGA Blocking Assay | Day 211 | 15.5 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by HBGA Blocking Assay | Day 8 | 0.0 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by HBGA Blocking Assay | Day 393 | 12.9 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by HBGA Blocking Assay | Day 29 | 0.0 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by HBGA Blocking Assay | Day 36 | 26.4 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by HBGA Blocking Assay | Day 211 | 18.2 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by HBGA Blocking Assay | Day 36 | 45.5 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by HBGA Blocking Assay | Day 29 | 40.9 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by HBGA Blocking Assay | Day 393 | 10.9 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by HBGA Blocking Assay | Day 8 | 33.8 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by HBGA Blocking Assay | Day 36 | 34.4 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by HBGA Blocking Assay | Day 8 | 0.0 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by HBGA Blocking Assay | Day 29 | 0.0 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by HBGA Blocking Assay | Day 211 | 28.1 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by HBGA Blocking Assay | Day 393 | 19.0 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by HBGA Blocking Assay | Day 393 | 16.9 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by HBGA Blocking Assay | Day 8 | 55.4 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by HBGA Blocking Assay | Day 211 | 30.3 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by HBGA Blocking Assay | Day 36 | 63.6 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by HBGA Blocking Assay | Day 29 | 54.5 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by HBGA Blocking Assay | Day 36 | 43.5 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by HBGA Blocking Assay | Day 211 | 8.7 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by HBGA Blocking Assay | Day 8 | 0.0 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by HBGA Blocking Assay | Day 393 | 13.0 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by HBGA Blocking Assay | Day 29 | 0.0 percentage of participants |
Secondary
Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by Total Immunoglobulin-Enzyme-linked Immunosorbent Assay (Pan-Ig ELISA)
Percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 VLP and GII.4 VLP measured by Pan-Ig ELISA are reported.
Time frame: Days 8, 29, 36, 57, 211 and 393
Population: PPS included all participants in the FAS, who received the planned vaccination (both doses of vaccine, i.e. NoV VLP vaccine or placebo), and did not have major protocol violations. Number analyzed is the number of participants with evaluable data at the given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by Total Immunoglobulin-Enzyme-linked Immunosorbent Assay (Pan-Ig ELISA) | Day 8 | 0.0 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by Total Immunoglobulin-Enzyme-linked Immunosorbent Assay (Pan-Ig ELISA) | Day 36 | 37.5 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by Total Immunoglobulin-Enzyme-linked Immunosorbent Assay (Pan-Ig ELISA) | Day 211 | 40.8 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by Total Immunoglobulin-Enzyme-linked Immunosorbent Assay (Pan-Ig ELISA) | Day 393 | 24.3 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by Total Immunoglobulin-Enzyme-linked Immunosorbent Assay (Pan-Ig ELISA) | Day 29 | 1.4 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by Total Immunoglobulin-Enzyme-linked Immunosorbent Assay (Pan-Ig ELISA) | Day 57 | 52.1 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by Total Immunoglobulin-Enzyme-linked Immunosorbent Assay (Pan-Ig ELISA) | Day 211 | 37.9 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by Total Immunoglobulin-Enzyme-linked Immunosorbent Assay (Pan-Ig ELISA) | Day 29 | 47.8 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by Total Immunoglobulin-Enzyme-linked Immunosorbent Assay (Pan-Ig ELISA) | Day 8 | 31.8 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by Total Immunoglobulin-Enzyme-linked Immunosorbent Assay (Pan-Ig ELISA) | Day 393 | 15.4 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by Total Immunoglobulin-Enzyme-linked Immunosorbent Assay (Pan-Ig ELISA) | Day 36 | 49.3 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by Total Immunoglobulin-Enzyme-linked Immunosorbent Assay (Pan-Ig ELISA) | Day 57 | 43.9 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by Total Immunoglobulin-Enzyme-linked Immunosorbent Assay (Pan-Ig ELISA) | Day 393 | 25.4 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by Total Immunoglobulin-Enzyme-linked Immunosorbent Assay (Pan-Ig ELISA) | Day 211 | 40.6 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by Total Immunoglobulin-Enzyme-linked Immunosorbent Assay (Pan-Ig ELISA) | Day 57 | 58.1 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by Total Immunoglobulin-Enzyme-linked Immunosorbent Assay (Pan-Ig ELISA) | Day 8 | 0.0 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by Total Immunoglobulin-Enzyme-linked Immunosorbent Assay (Pan-Ig ELISA) | Day 29 | 0.0 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by Total Immunoglobulin-Enzyme-linked Immunosorbent Assay (Pan-Ig ELISA) | Day 36 | 39.1 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by Total Immunoglobulin-Enzyme-linked Immunosorbent Assay (Pan-Ig ELISA) | Day 57 | 62.1 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by Total Immunoglobulin-Enzyme-linked Immunosorbent Assay (Pan-Ig ELISA) | Day 8 | 52.3 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by Total Immunoglobulin-Enzyme-linked Immunosorbent Assay (Pan-Ig ELISA) | Day 29 | 62.1 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by Total Immunoglobulin-Enzyme-linked Immunosorbent Assay (Pan-Ig ELISA) | Day 36 | 63.6 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by Total Immunoglobulin-Enzyme-linked Immunosorbent Assay (Pan-Ig ELISA) | Day 211 | 42.4 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by Total Immunoglobulin-Enzyme-linked Immunosorbent Assay (Pan-Ig ELISA) | Day 393 | 23.1 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by Total Immunoglobulin-Enzyme-linked Immunosorbent Assay (Pan-Ig ELISA) | Day 211 | 47.8 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by Total Immunoglobulin-Enzyme-linked Immunosorbent Assay (Pan-Ig ELISA) | Day 36 | 69.6 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by Total Immunoglobulin-Enzyme-linked Immunosorbent Assay (Pan-Ig ELISA) | Day 29 | 0.0 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by Total Immunoglobulin-Enzyme-linked Immunosorbent Assay (Pan-Ig ELISA) | Day 8 | 0.0 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by Total Immunoglobulin-Enzyme-linked Immunosorbent Assay (Pan-Ig ELISA) | Day 393 | 30.4 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus Antibody Titers for Both GI.1 VLP and GII.4 VLP as Measured by Total Immunoglobulin-Enzyme-linked Immunosorbent Assay (Pan-Ig ELISA) | Day 57 | 62.5 percentage of participants |
Secondary
Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (HBGA)
Time frame: Days 8, 29, 36, 57, 211 and 393
Population: PPS included all participants in the FAS, who received the planned vaccination (both doses of vaccine, i.e. NoV VLP vaccine or placebo), and did not have major protocol violations. Number analyzed is the number of participants with evaluable data at the given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 36 | 55.6 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 211 | 33.8 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 29 | 0.0 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 393 | 25.7 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 8 | 1.4 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 57 | 64.8 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 57 | 80.0 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 36 | 74.2 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 8 | 63.1 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 393 | 50.0 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 211 | 57.6 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 29 | 72.7 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 36 | 65.6 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 393 | 41.3 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 8 | 0.0 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 29 | 0.0 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 57 | 74.2 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 211 | 54.7 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 8 | 76.9 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 57 | 89.4 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 211 | 57.6 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 29 | 77.3 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 36 | 89.4 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 393 | 47.7 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 36 | 60.9 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 57 | 62.5 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 8 | 0.0 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 393 | 30.4 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 211 | 26.1 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (HBGA) | Day 29 | 0.0 percentage of participants |
Secondary
Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA)
Percentage of participants with a 4-Fold rise or greater in serum anti-norovirus GI.1 VLP antibody titers measured by Pan-Ig ELISA are reported.
Time frame: Days 8, 29, 36, 57, 211 and 393
Population: PPS included all participants in the FAS, who received the planned vaccination (both doses of vaccine, i.e. NoV VLP vaccine or placebo), and did not have major protocol violations. Number analyzed is the number of participants with evaluable data at the given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 211 | 62.0 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 36 | 59.7 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 57 | 73.2 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 8 | 0.0 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 393 | 48.6 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 29 | 1.4 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 8 | 56.1 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 29 | 67.2 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 393 | 41.5 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 36 | 67.2 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 57 | 65.2 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 211 | 63.6 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 8 | 0.0 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 36 | 68.8 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 211 | 70.3 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 57 | 83.9 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 29 | 0.0 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 393 | 52.4 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 211 | 72.7 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 36 | 83.3 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 8 | 69.2 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 29 | 80.3 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 57 | 84.8 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 393 | 60.0 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 29 | 8.3 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 57 | 87.5 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 36 | 91.3 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 393 | 60.9 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 8 | 0.0 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Day 211 | 73.9 percentage of participants |
Secondary
Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (HBGA)
Time frame: Days 8, 29, 36, 57, 211 and 393
Population: PPS included all participants in the FAS, who received the planned vaccination (both doses of vaccine, i.e. NoV VLP vaccine or placebo), and did not have major protocol violations. Number analyzed is the number of participants with evaluable data at the given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 57 | 67.6 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 29 | 1.4 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 36 | 56.9 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 8 | 0.0 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 211 | 39.4 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 393 | 34.3 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 393 | 30.8 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 211 | 34.8 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 8 | 54.5 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 29 | 59.7 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 36 | 62.7 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 57 | 57.6 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 36 | 53.1 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 29 | 0.0 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 8 | 1.5 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 211 | 45.3 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 393 | 33.3 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 57 | 74.2 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 8 | 69.2 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 29 | 71.2 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 36 | 71.2 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 57 | 71.2 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 211 | 45.5 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 393 | 36.9 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 211 | 47.8 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 36 | 78.3 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 29 | 0.0 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 8 | 0.0 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 57 | 66.7 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (HBGA) | Day 393 | 39.1 percentage of participants |
Secondary
Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA)
Percentage of participants with a 4-fold rise or greater in serum anti-norovirus GII.4 VLP antibody titers measured by Pan-Ig ELISA are reported.
Time frame: Days 8, 29, 36, 57, 211 and 393
Population: PPS included all participants in the FAS, who received the planned vaccination (both doses of vaccine, i.e. NoV VLP vaccine or placebo), and did not have major protocol violations. Number analyzed is the number of participants with evaluable data at the given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 211 | 60.6 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 8 | 0.0 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 393 | 34.3 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 36 | 52.8 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 57 | 70.4 percentage of participants |
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 29 | 0.0 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 211 | 53.0 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 57 | 63.6 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 393 | 32.3 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 8 | 50.0 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 36 | 68.7 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 29 | 70.8 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 36 | 48.4 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 8 | 0.0 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 57 | 67.7 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 211 | 50.0 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 393 | 34.9 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 29 | 0.0 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 211 | 53.0 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 393 | 36.9 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 57 | 68.2 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 8 | 62.5 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 29 | 70.8 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 36 | 71.2 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 36 | 73.9 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 211 | 52.2 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 393 | 34.8 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 8 | 0.0 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 57 | 66.7 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Day 29 | 0.0 percentage of participants |
Secondary
Percentage of Participants With At Least One Adverse Event (AE) Leading to Participant's Withdrawal From the Study
Withdrawal due to an AE will occur if the participant experiences an AE that requires early termination of treatment, because continued participation imposes an unacceptable risk to the participant's health or the participant is unwilling to continue because of the AE.
Time frame: From first vaccination up to Day 393
Population: SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With At Least One Adverse Event (AE) Leading to Participant's Withdrawal From the Study | 1.3 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With At Least One Adverse Event (AE) Leading to Participant's Withdrawal From the Study | 1.4 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With At Least One Adverse Event (AE) Leading to Participant's Withdrawal From the Study | 0.0 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With At Least One Adverse Event (AE) Leading to Participant's Withdrawal From the Study | 1.4 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With At Least One Adverse Event (AE) Leading to Participant's Withdrawal From the Study | 0.0 percentage of participants |
Secondary
Percentage of Participants With At Least One Adverse Event of Special Interest (AESI)
AESIs are AEs that are not solicited local or systemic AEs, they are predefined AEs that required close monitoring and prompt reporting to the sponsor. AESI included protocol specified Cardiac Disorders, Gastrointestinal Disorders, Immune System Disorders, Infections and Infestations, Musculoskeletal and Connective Tissue Diseases, Neuroinflammatory Disorders, Renal and Urinary Disorders, Skin Disorders, Thyroid Disorders, Vascular Disorders and Other Disorders.
Time frame: From first vaccination up to Day 393
Population: SAF included all participants who received at least 1 dose of vaccine (NoV VLP vaccine or placebo).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With At Least One Adverse Event of Special Interest (AESI) | 1.3 percentage of participants |
| Arm 2: NoV Vaccine Formulation A_2-Dose | Percentage of Participants With At Least One Adverse Event of Special Interest (AESI) | 2.7 percentage of participants |
| Arm 3: NoV Vaccine Formulation B_1-Dose | Percentage of Participants With At Least One Adverse Event of Special Interest (AESI) | 2.8 percentage of participants |
| Arm 4: NoV Vaccine Formulation B_2-Dose | Percentage of Participants With At Least One Adverse Event of Special Interest (AESI) | 0.0 percentage of participants |
| Arm 5: NoV Vaccine Formulation A_1-Dose | Percentage of Participants With At Least One Adverse Event of Special Interest (AESI) | 0.0 percentage of participants |