CompletedNCT02661490Updated May 18, 2020Results posted

Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine in an Elderly Population

A Phase 2 interventional study of Norovirus GI.1/GII.4 Bivalent VLP Vaccine and 0.9% sodium chloride (saline) in Norovirus, sponsored by Takeda. Completed at 10 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-18.

Sponsored by Takeda · Phase 2, Interventional, and Prevention

Phase: Phase 2
Study type: Interventional
Enrollment: 320
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Read the detailed description

The vaccine being tested in this study is called norovirus GI.1/GII.4 bivalent virus-like particle (VLP) vaccine adjuvanted with aluminum hydroxide (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.

Conditions studied

Norovirus

Keywords

Norovirus

In context

Lead sponsor

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

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

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

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

Has a known hypersensitivity or allergy to any of the Norovirus (NoV) GI.1/GII.4 Bivalent virus-like particle (VLP) Vaccine components;
Has a clinically significant active infection (as assessed by the Investigator) or body temperature ≥38°C/100.4°F within 3 days of the intended date of vaccination;
Participants with the presence of significant acute or chronic, uncontrolled medical or neuropsychiatric illness. Uncontrolled was defined as:
Requiring institution of new medical or surgical treatment within 3 months prior to immunization, or Requiring a change in medication dosage in the 3 months prior to immunization due to uncontrolled symptoms or drug toxicity (elective dosage adjustments in stable participants were acceptable), or Hospitalization or an event fulfilling the definition of a serious adverse event within 3 months prior immunization.
Has any unstable medical or neuropsychiatric condition, which in the Investigator's opinion poses a risk of unusual magnitude for the participant's age group of hospitalization, death, or an event meeting the definition of a serious adverse event within 2 months of immunization. The intent of this criterion is to recognize and allow for the frequent existence of significant health concerns in this population; but exclude those participants who are experiencing an acute decline in health status;
Has any medical or neuropsychiatric condition, which in the Investigator's opinion, rendered the participant incompetent to provide informed consent or unable to provide valid safety observations and reports;
Has behavioral or cognitive impairment or psychiatric disease that, in the opinion of the Investigator, may interfere with the participant's ability to participate in the trial;
Participants with any history of progressive or severe neurologic disorder, history of seizure, or history of neuro-inflammatory disease (e.g. Guillain-Barre syndrome);
Participants with history or any illness that, in the opinion of the Investigator, might interfere with the results of the trial or pose additional risk to the participants due to participation in the trial;
Has known or suspected autoimmune disease;
Has known or suspected impairment/alteration of immune function, including:
Chronic use of oral steroids (Equivalent to 20 mg/day prednisone ≥ 12 weeks/≥ 2 mg/kg body weight/day prednisone ≥ 2 weeks) within 60 days prior to Day 1 (use of inhaled, intranasal, or topical corticosteroids is allowed).
Receipt of parenteral steroids (Equivalent to 20 mg/day prednisone ≥ 12 weeks/≥ 2 mg/kg body weight/day prednisone ≥ 2 weeks) within 60 days prior to Day 1.
Receipt of immunosuppressive therapy within 3 months prior to Day 1. Receipt of immunostimulants within 60 days prior to Day 1. Receipt of parenteral, epidural or intra-articular immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to Day 1 or planned during the full length of the trial.
Human Immunodeficiency Virus (HIV) infection or HIV-related disease. Genetic immunodeficiency.
Has abnormalities of splenic or thymic function;
Has any significant disorder of coagulation or treatment with anticoagulant therapy that would increase the risk of intramuscular (IM) injection. Persons receiving prophylactic antiplatelet medication such as low dose of acetylsalicylic acid are eligible;
Has any serious chronic or progressive disease according to judgment of the Investigator: cancer (malignancy other than resolved/excised skin lesion), insulin dependent Type I diabetes (Type II diabetes is accepted), cardiac, renal or hepatic disease;
Has body mass index (BMI) greater than or equal to 35 kg/m\^2 (= weight in kg/[height in meters\^2]);
Is participating in any clinical trial with another investigational product 30 days prior to first trial visit or intent to participate in another clinical trial at any time during the conduct of this trial;
Participants who received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this trial or who are planning to receive any vaccine within 28 days of investigational vaccine administration;
Participants involved in trial conduct or their first degree relatives;
Has history of substance or alcohol abuse within the past 2 years;
Females who are pregnant or breastfeeding;
If female of childbearing potential, sexually active with a male partner who has not been sterilized, and has not used any of the "acceptable contraceptive methods" for at least 2 months prior to trial entry:
Of childbearing potential is defined as status post onset of menarche and not meeting any of the following conditions: menopausal for at least 2 years, status after bilateral tubal ligation for at least 1 year, status after bilateral oophorectomy, or status after hysterectomy.
Acceptable birth control methods are defined as one or more of the following: i. Hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical ring); ii. Barrier (condom with spermicide or diaphragm with spermicide) each and every time during intercourse; iii. Intrauterine device (IUD); iv. Monogamous relationship with vasectomized partner. Partner must have been vasectomized for at least six months prior to the participants' trial entry.
If female of childbearing potential and sexually active, refusal to use an "acceptable contraceptive method" from Day 1 and throughout the duration of the trial. In addition, they must be advised not to donate ova during this period;
Females with any positive or indeterminate pregnancy test.

Study design

Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 320 participants (actual)

Study arms

Experimental
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.
Biological: Norovirus GI.1/GII.4 Bivalent VLP Vaccine · Drug: 0.9% sodium chloride (saline)
Experimental
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.
Biological: Norovirus GI.1/GII.4 Bivalent VLP Vaccine
Experimental
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.
Drug: 0.9% sodium chloride (saline) · Biological: Norovirus GI.1/GII.4 Bivalent VLP Vaccine
Experimental
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.
Biological: Norovirus GI.1/GII.4 Bivalent VLP Vaccine
Experimental
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.
Biological: Norovirus GI.1/GII.4 Bivalent VLP Vaccine · Drug: 0.9% sodium chloride (saline)

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
BiologicalNorovirus GI.1/GII.4 Bivalent VLP Vaccine
Norovirus GI.1/GII.4 bivalent VLP vaccine adjuvanted with MPL and aluminum hydroxide for IM injection

What researchers measure

Primary outcomes

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
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
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
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
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
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
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
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
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
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

Secondary outcomes

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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Results

Posted May 18, 2020

Participant flow

Participants took part in the study at 10 investigative sites in United States from 1 February 2016 to 31 October 2017.

Participant flow — Overall Study
Milestone	Arm 1: NoV Vaccine Formulation A_1-Dose	Arm 2: NoV Vaccine Formulation A_2-Dose	Arm 3: NoV Vaccine Formulation B_1-Dose	Arm 4: NoV Vaccine Formulation B_2-Dose	Arm 5: NoV Vaccine Formulation A_1-Dose
Started	76	74	72	72	26
Completed	73	72	70	71	23
Not completed	3	2	2	1	3
Withdrew: Lost to follow-up	0	1	0	0	2
Withdrew: Withdrawal by subject	2	0	2	0	0
Withdrew: Death	1	1	0	1	0
Withdrew: Reason not specified	0	0	0	0	1

Outcome measures

PrimaryPercentage 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
Reported as:: Number · percentage of participants

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
percentage of participants	Arm 1: NoV Vaccine Formulation A_1-Dose	Arm 2: NoV Vaccine Formulation A_2-Dose	Arm 3: NoV Vaccine Formulation B_1-Dose	Arm 4: NoV Vaccine Formulation B_2-Dose	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	42.3 (30.6 to 54.6)	41.5 (29.4 to 54.4)	56.5 (43.3 to 69.0)	63.6 (50.9 to 75.1)	45.8 (25.6 to 67.2)

PrimaryPercentage 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
Reported as:: Number · percentage of participants

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
percentage of participants	Arm 1: NoV Vaccine Formulation A_1-Dose	Arm 2: NoV Vaccine Formulation A_2-Dose	Arm 3: NoV Vaccine Formulation B_1-Dose	Arm 4: NoV Vaccine Formulation B_2-Dose	Arm 5: NoV Vaccine Formulation A_1-Dose
Any Solicited Local AEs	6.6	26.0	15.3	34.7	4.0
Pain	5.3	23.3	9.7	34.7	4.0
Erythema	1.3	2.7	4.2	1.4	4.0
Swelling	0.0	2.7	2.8	1.4	0.0
Induration	0.0	1.4	1.4	1.4	0.0

PrimaryPercentage 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
Reported as:: Number · percentage of participants

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
percentage of participants	Arm 1: NoV Vaccine Formulation A_1-Dose	Arm 2: NoV Vaccine Formulation A_2-Dose	Arm 3: NoV Vaccine Formulation B_1-Dose	Arm 4: NoV Vaccine Formulation B_2-Dose	Arm 5: NoV Vaccine Formulation A_1-Dose
Any Solicited Local AEs	37.0	21.7	38.2	39.4	41.7
Pain	32.9	21.7	38.2	37.9	41.7
Erythema	2.7	0.0	1.5	3.0	0.0
Swelling	1.4	0.0	1.5	1.5	0.0
Induration	1.4	0.0	1.5	1.5	0.0

PrimaryPercentage 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
Reported as:: Number · percentage of participants

Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After First Vaccination on Day 1
percentage of participants	Arm 1: NoV Vaccine Formulation A_1-Dose	Arm 2: NoV Vaccine Formulation A_2-Dose	Arm 3: NoV Vaccine Formulation B_1-Dose	Arm 4: NoV Vaccine Formulation B_2-Dose	Arm 5: NoV Vaccine Formulation A_1-Dose
Any solicited systemic AEs	28.9	34.2	30.6	44.4	36.0
Headache	7.9	2.7	11.1	12.5	20.0
Fatigue	18.4	24.7	9.7	27.8	28.0
Myalgia	5.3	13.7	11.1	20.8	16.0
Arthralgia	5.3	8.2	6.9	6.9	4.0
Vomiting	0.0	1.4	0.0	2.8	0.0
Diarrhea	5.3	6.8	8.3	18.1	8.0

PrimaryPercentage 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
Reported as:: Number · percentage of participants

Percentage of Participants With Solicited Systemic Adverse Events (AEs) for 7-day Period (Including Day of Vaccination) After Second Vaccination on Day 29
percentage of participants	Arm 1: NoV Vaccine Formulation A_1-Dose	Arm 2: NoV Vaccine Formulation A_2-Dose	Arm 3: NoV Vaccine Formulation B_1-Dose	Arm 4: NoV Vaccine Formulation B_2-Dose	Arm 5: NoV Vaccine Formulation A_1-Dose
Any solicited systemic AEs	19.2	20.3	20.6	28.8	16.7
Headache	8.2	5.8	5.9	6.1	4.2
Fatigue	12.3	15.9	13.2	15.2	8.3
Myalgia	6.8	5.8	7.4	13.6	4.2
Arthralgia	4.1	7.2	4.4	6.1	4.2
Vomiting	0.0	0.0	0.0	1.5	0.0
Diarrhea	1.4	4.3	2.9	4.5	0.0

PrimaryPercentage 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
Reported as:: Number · percentage of participants

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
percentage of participants	Arm 1: NoV Vaccine Formulation A_1-Dose	Arm 2: NoV Vaccine Formulation A_2-Dose	Arm 3: NoV Vaccine Formulation B_1-Dose	Arm 4: NoV Vaccine Formulation B_2-Dose	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	0.0	0.0	0.0	0.0

PrimaryPercentage 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

Time frame:: Within 7 days of second vaccination on Day 29
Reported as:: Number · percentage of participants

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
percentage of participants	Arm 1: NoV Vaccine Formulation A_1-Dose	Arm 2: NoV Vaccine Formulation A_2-Dose	Arm 3: NoV Vaccine Formulation B_1-Dose	Arm 4: NoV Vaccine Formulation B_2-Dose	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	0.0	0.0	1.5	0.0

PrimaryPercentage 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
Reported as:: Number · percentage of participants

Percentage of Participants With At Least One Unsolicited Adverse Event (AE) Within 28-days After First Vaccination on Day 1
percentage of participants	Arm 1: NoV Vaccine Formulation A_1-Dose	Arm 2: NoV Vaccine Formulation A_2-Dose	Arm 3: NoV Vaccine Formulation B_1-Dose	Arm 4: NoV Vaccine Formulation B_2-Dose	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	32.9	28.4	33.3	26.4	20.0

PrimaryPercentage 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
Reported as:: Number · percentage of participants

Percentage of Participants With At Least One Unsolicited Adverse Event (AE) Within 28-days After Second Vaccination on Day 29
percentage of participants	Arm 1: NoV Vaccine Formulation A_1-Dose	Arm 2: NoV Vaccine Formulation A_2-Dose	Arm 3: NoV Vaccine Formulation B_1-Dose	Arm 4: NoV Vaccine Formulation B_2-Dose	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	34.2	18.8	25.0	30.3	8.3

PrimaryPercentage 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
Reported as:: Number · percentage of participants

Percentage of Participants With At Least One Serious Adverse Event (SAE)
percentage of participants	Arm 1: NoV Vaccine Formulation A_1-Dose	Arm 2: NoV Vaccine Formulation A_2-Dose	Arm 3: NoV Vaccine Formulation B_1-Dose	Arm 4: NoV Vaccine Formulation B_2-Dose	Arm 5: NoV Vaccine Formulation A_1-Dose
Percentage of Participants With At Least One Serious Adverse Event (SAE)	9.2	12.2	23.6	12.5	0.0

SecondaryPercentage 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
Reported as:: Number · percentage of participants

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
percentage of participants	Arm 1: NoV Vaccine Formulation A_1-Dose	Arm 2: NoV Vaccine Formulation A_2-Dose	Arm 3: NoV Vaccine Formulation B_1-Dose	Arm 4: NoV Vaccine Formulation B_2-Dose	Arm 5: NoV Vaccine Formulation A_1-Dose
Day 8	0.0 (0.0 to 5.0)	33.8 (22.6 to 46.6)	0.0 (0.0 to 5.4)	55.4 (42.5 to 67.7)	0.0 (0.0 to 14.8)
Day 29	0.0 (0.0 to 5.0)	40.9 (29.0 to 53.7)	0.0 (0.0 to 5.4)	54.5 (41.8 to 66.9)	0.0 (0.0 to 14.2)
Day 36	26.4 (16.7 to 38.1)	45.5 (33.1 to 58.2)	34.4 (22.9 to 47.3)	63.6 (50.9 to 75.1)	43.5 (23.2 to 65.5)
Day 211	15.5 (8.0 to 26.0)	18.2 (9.8 to 29.6)	28.1 (17.6 to 40.8)	30.3 (19.6 to 42.9)	8.7 (1.1 to 28.0)
Day 393	12.9 (6.1 to 23.0)	10.9 (4.5 to 21.2)	19.0 (10.2 to 30.9)	16.9 (8.8 to 28.3)	13.0 (2.8 to 33.6)

SecondaryPercentage 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
Reported as:: Number · percentage of participants

Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GI.1 VLP Antibody Titers (HBGA)
percentage of participants	Arm 1: NoV Vaccine Formulation A_1-Dose	Arm 2: NoV Vaccine Formulation A_2-Dose	Arm 3: NoV Vaccine Formulation B_1-Dose	Arm 4: NoV Vaccine Formulation B_2-Dose	Arm 5: NoV Vaccine Formulation A_1-Dose
Day 8	1.4 (0.0 to 7.5)	63.1 (50.2 to 74.7)	0.0 (0.0 to 5.4)	76.9 (64.8 to 86.5)	0.0 (0.0 to 14.8)
Day 29	0.0 (0.0 to 5.0)	72.7 (60.4 to 83.0)	0.0 (0.0 to 5.4)	77.3 (65.3 to 86.7)	0.0 (0.0 to 14.2)
Day 36	55.6 (43.4 to 67.3)	74.2 (62.0 to 84.2)	65.6 (52.7 to 77.1)	89.4 (79.4 to 95.6)	60.9 (38.5 to 80.3)
Day 57	64.8 (52.5 to 75.8)	80.0 (68.2 to 88.9)	74.2 (61.5 to 84.5)	89.4 (79.4 to 95.6)	62.5 (40.6 to 81.2)
Day 211	33.8 (23.0 to 46.0)	57.6 (44.8 to 69.7)	54.7 (41.7 to 67.2)	57.6 (44.8 to 69.7)	26.1 (10.2 to 48.4)
Day 393	25.7 (16.0 to 37.6)	50.0 (37.2 to 62.8)	41.3 (29.0 to 54.4)	47.7 (35.1 to 60.5)	30.4 (13.2 to 52.9)

SecondaryPercentage 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
Reported as:: Number · percentage of participants

Percentage of Participants With a 4-Fold Rise or Greater in Serum Anti-norovirus GII.4 VLP Antibody Titers (HBGA)
percentage of participants	Arm 1: NoV Vaccine Formulation A_1-Dose	Arm 2: NoV Vaccine Formulation A_2-Dose	Arm 3: NoV Vaccine Formulation B_1-Dose	Arm 4: NoV Vaccine Formulation B_2-Dose	Arm 5: NoV Vaccine Formulation A_1-Dose
Day 8	0.0 (0.0 to 5.0)	54.5 (41.8 to 66.9)	1.5 (0.0 to 8.2)	69.2 (56.6 to 80.1)	0.0 (0.0 to 14.8)
Day 29	1.4 (0.0 to 7.5)	59.7 (47.0 to 71.5)	0.0 (0.0 to 5.4)	71.2 (58.7 to 81.7)	0.0 (0.0 to 14.2)
Day 36	56.9 (44.7 to 68.6)	62.7 (50.0 to 74.2)	53.1 (40.2 to 65.7)	71.2 (58.7 to 81.7)	78.3 (56.3 to 92.5)
Day 57	67.6 (55.5 to 78.2)	57.6 (44.8 to 69.7)	74.2 (61.5 to 84.5)	71.2 (58.7 to 81.7)	66.7 (44.7 to 84.4)
Day 211	39.4 (28.0 to 51.7)	34.8 (23.5 to 47.6)	45.3 (32.8 to 58.3)	45.5 (33.1 to 58.2)	47.8 (26.8 to 69.4)
Day 393	34.3 (23.3 to 46.6)	30.8 (19.9 to 43.4)	33.3 (22.0 to 46.3)	36.9 (25.3 to 49.8)	39.1 (19.7 to 61.5)

SecondaryGeometric 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
Reported as:: Geometric mean · titer

Geometric Mean Titer (GMT) GI.1 VLP Antibody Titers (HBGA)
titer	Arm 1: NoV Vaccine Formulation A_1-Dose	Arm 2: NoV Vaccine Formulation A_2-Dose	Arm 3: NoV Vaccine Formulation B_1-Dose	Arm 4: NoV Vaccine Formulation B_2-Dose	Arm 5: NoV Vaccine Formulation A_1-Dose
Baseline (Day 1)	26.5 (20.9 to 33.6)	29.0 (22.3 to 37.7)	26.7 (20.9 to 34.2)	23.9 (19.8 to 28.8)	22.0 (15.4 to 31.6)
Day 8	26.6 (20.9 to 33.9)	282.4 (193.2 to 412.6)	26.5 (20.9 to 33.6)	332.3 (209.9 to 526.1)	21.7 (15.3 to 30.8)
Day 29	26.2 (20.8 to 33.0)	373.6 (266.9 to 523.0)	27.3 (21.4 to 34.8)	285.5 (192.9 to 422.6)	21.7 (15.3 to 30.9)
Day 36	194.2 (130.3 to 289.4)	361.1 (266.5 to 489.2)	280.1 (184.3 to 425.7)	338.9 (247.7 to 463.7)	150.8 (75.0 to 303.4)
Day 57	177.0 (124.4 to 251.9)	353.6 (268.6 to 465.6)	262.2 (180.5 to 381.0)	317.1 (238.3 to 421.9)	117.7 (63.1 to 219.5)
Day 211	81.8 (60.4 to 110.6)	160.5 (116.5 to 221.1)	128.3 (92.7 to 177.7)	126.7 (92.7 to 173.3)	54.1 (30.1 to 97.0)
Day 393	60.2 (43.9 to 82.5)	112.2 (80.4 to 156.5)	85.7 (61.8 to 118.9)	84.6 (60.3 to 118.5)	41.0 (23.3 to 72.2)

SecondaryGMT 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
Reported as:: Geometric mean · titer

GMT of Anti-norovirus GII.4 VLP Antibody Titers (HBGA)
titer	Arm 1: NoV Vaccine Formulation A_1-Dose	Arm 2: NoV Vaccine Formulation A_2-Dose	Arm 3: NoV Vaccine Formulation B_1-Dose	Arm 4: NoV Vaccine Formulation B_2-Dose	Arm 5: NoV Vaccine Formulation A_1-Dose
Baseline (Day 1)	66.5 (48.4 to 91.4)	100.3 (70.8 to 142.2)	99.5 (67.4 to 146.8)	86.1 (60.7 to 122.2)	78.7 (43.7 to 141.4)
Day 8	60.7 (43.8 to 84.2)	694.9 (462.6 to 1043.9)	94.1 (65.2 to 135.8)	994.9 (724.8 to 1365.8)	75.2 (41.3 to 137.0)
Day 29	58.6 (42.0 to 81.6)	787.7 (524.9 to 1182.1)	82.8 (57.5 to 119.3)	876.1 (648.5 to 1183.6)	67.2 (38.0 to 118.8)
Day 36	556.5 (354.6 to 873.2)	757.1 (526.7 to 1088.4)	733.8 (460.0 to 1170.7)	799.4 (604.1 to 1057.9)	1234.5 (627.3 to 2429.4)
Day 57	528.0 (366.2 to 761.2)	600.6 (417.3 to 864.5)	790.8 (543.4 to 1151.0)	613.6 (475.5 to 791.8)	742.0 (406.9 to 1352.9)
Day 211	222.0 (158.2 to 311.6)	298.9 (204.6 to 436.6)	318.6 (228.6 to 444.1)	315.9 (233.7 to 427.1)	280.3 (163.4 to 480.8)
Day 393	188.9 (129.7 to 275.1)	249.8 (164.4 to 379.8)	265.9 (184.4 to 383.6)	278.9 (204.9 to 379.7)	223.4 (114.5 to 436.0)

SecondaryGeometric 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
Reported as:: Geometric mean · ratio

Geometric Mean Fold Rise (GMFR) of Anti-norovirus GI.1 VLP Antibody Titers (HBGA)
ratio	Arm 1: NoV Vaccine Formulation A_1-Dose	Arm 2: NoV Vaccine Formulation A_2-Dose	Arm 3: NoV Vaccine Formulation B_1-Dose	Arm 4: NoV Vaccine Formulation B_2-Dose	Arm 5: NoV Vaccine Formulation A_1-Dose
Day 8	1.0 (0.9 to 1.1)	10.1 (6.6 to 15.6)	1.0 (0.9 to 1.0)	14.1 (9.2 to 21.6)	1.0 (0.9 to 1.0)
Day 29	1.0 (1.0 to 1.0)	13.0 (9.1 to 18.6)	1.0 (1.0 to 1.1)	12.0 (8.5 to 16.8)	1.0 (0.9 to 1.1)
Day 36	7.3 (4.9 to 10.9)	12.6 (9.1 to 17.4)	10.6 (7.0 to 15.9)	14.2 (10.7 to 18.8)	7.5 (3.9 to 14.6)
Day 57	6.6 (4.8 to 9.1)	12.1 (9.1 to 16.2)	10.0 (7.1 to 14.0)	13.3 (10.3 to 17.1)	5.3 (3.0 to 9.6)
Day 211	3.2 (2.6 to 4.0)	5.5 (4.2 to 7.3)	4.8 (3.7 to 6.3)	5.3 (4.1 to 6.8)	2.4 (1.4 to 4.0)
Day 393	2.4 (1.9 to 3.0)	3.9 (3.0 to 5.2)	3.2 (2.5 to 4.1)	3.5 (2.7 to 4.6)	1.8 (1.1 to 2.9)

SecondaryGMFR 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
Reported as:: Geometric mean · ratio

GMFR of Anti-norovirus GII.4 VLP Antibody Titers (HBGA)
ratio	Arm 1: NoV Vaccine Formulation A_1-Dose	Arm 2: NoV Vaccine Formulation A_2-Dose	Arm 3: NoV Vaccine Formulation B_1-Dose	Arm 4: NoV Vaccine Formulation B_2-Dose	Arm 5: NoV Vaccine Formulation A_1-Dose
Day 8	0.9 (0.8 to 1.0)	6.9 (4.5 to 10.5)	0.9 (0.8 to 1.1)	11.6 (7.7 to 17.5)	0.9 (0.8 to 1.0)
Day 29	0.9 (0.8 to 1.0)	7.9 (5.6 to 11.0)	0.8 (0.7 to 1.0)	10.2 (7.2 to 14.5)	0.9 (0.8 to 1.0)
Day 36	8.4 (5.4 to 13.0)	7.5 (5.5 to 10.4)	7.3 (4.8 to 11.2)	9.3 (6.6 to 13.0)	15.1 (7.1 to 32.2)
Day 57	8.1 (5.8 to 11.4)	5.8 (4.3 to 7.8)	8.4 (6.1 to 11.7)	7.1 (5.3 to 9.6)	9.4 (4.8 to 18.4)
Day 211	3.4 (2.6 to 4.5)	3.0 (2.2 to 4.1)	3.4 (2.5 to 4.5)	3.7 (2.8 to 4.8)	3.8 (2.2 to 6.5)
Day 393	3.0 (2.3 to 3.8)	2.6 (2.0 to 3.5)	2.7 (2.1 to 3.5)	3.2 (2.4 to 4.1)	3.0 (1.7 to 5.4)

SecondaryPercentage 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
Reported as:: Number · percentage of participants

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	Arm 1: NoV Vaccine Formulation A_1-Dose	Arm 2: NoV Vaccine Formulation A_2-Dose	Arm 3: NoV Vaccine Formulation B_1-Dose	Arm 4: NoV Vaccine Formulation B_2-Dose	Arm 5: NoV Vaccine Formulation A_1-Dose
Day 8	0.0 (0.0 to 5.0)	31.8 (20.9 to 44.4)	0.0 (0.0 to 5.4)	52.3 (39.5 to 64.9)	0.0 (0.0 to 14.8)
Day 29	1.4 (0.0 to 7.5)	47.8 (35.4 to 60.3)	0.0 (0.0 to 5.4)	62.1 (49.3 to 73.8)	0.0 (0.0 to 14.2)
Day 36	37.5 (26.4 to 49.7)	49.3 (36.8 to 61.8)	39.1 (27.1 to 52.1)	63.6 (50.9 to 75.1)	69.6 (47.1 to 86.8)
Day 57	52.1 (39.9 to 64.1)	43.9 (31.7 to 56.7)	58.1 (44.8 to 70.5)	62.1 (49.3 to 73.8)	62.5 (40.6 to 81.2)
Day 211	40.8 (29.3 to 53.2)	37.9 (26.2 to 50.7)	40.6 (28.5 to 53.6)	42.4 (30.3 to 55.2)	47.8 (26.8 to 69.4)
Day 393	24.3 (14.8 to 36.0)	15.4 (7.6 to 26.5)	25.4 (15.3 to 37.9)	23.1 (13.5 to 35.2)	30.4 (13.2 to 52.9)

SecondaryPercentage 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
Reported as:: Number · percentage of participants

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	Arm 1: NoV Vaccine Formulation A_1-Dose	Arm 2: NoV Vaccine Formulation A_2-Dose	Arm 3: NoV Vaccine Formulation B_1-Dose	Arm 4: NoV Vaccine Formulation B_2-Dose	Arm 5: NoV Vaccine Formulation A_1-Dose
Day 8	0.0 (0.0 to 5.0)	56.1 (43.3 to 68.3)	0.0 (0.0 to 5.4)	69.2 (56.6 to 80.1)	0.0 (0.0 to 14.8)
Day 29	1.4 (0.0 to 7.5)	67.2 (54.6 to 78.2)	0.0 (0.0 to 5.4)	80.3 (68.7 to 89.1)	8.3 (1.0 to 27.0)
Day 36	59.7 (47.5 to 71.1)	67.2 (54.6 to 78.2)	68.8 (55.9 to 79.8)	83.3 (72.1 to 91.4)	91.3 (72.0 to 98.9)
Day 57	73.2 (61.4 to 83.1)	65.2 (52.4 to 76.5)	83.9 (72.3 to 92.0)	84.8 (73.9 to 92.5)	87.5 (67.6 to 97.3)
Day 211	62.0 (49.7 to 73.2)	63.6 (50.9 to 75.1)	70.3 (57.6 to 81.1)	72.7 (60.4 to 83.0)	73.9 (51.6 to 89.8)
Day 393	48.6 (36.4 to 60.8)	41.5 (29.4 to 54.4)	52.4 (39.4 to 65.1)	60.0 (47.1 to 72.0)	60.9 (38.5 to 80.3)

SecondaryPercentage 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
Reported as:: Number · percentage of participants

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	Arm 1: NoV Vaccine Formulation A_1-Dose	Arm 2: NoV Vaccine Formulation A_2-Dose	Arm 3: NoV Vaccine Formulation B_1-Dose	Arm 4: NoV Vaccine Formulation B_2-Dose	Arm 5: NoV Vaccine Formulation A_1-Dose
Day 8	0.0 (0.0 to 14.2)	50.0 (29.1 to 70.9)	0.0 (0.0 to 14.8)	62.5 (40.6 to 81.2)	0.0 (0.0 to 14.8)
Day 29	0.0 (0.0 to 14.2)	70.8 (48.9 to 87.4)	0.0 (0.0 to 14.8)	70.8 (48.9 to 87.4)	0.0 (0.0 to 14.2)
Day 36	52.8 (40.7 to 64.7)	68.7 (56.2 to 79.4)	48.4 (35.8 to 61.3)	71.2 (58.7 to 81.7)	73.9 (51.6 to 89.8)
Day 57	70.4 (58.4 to 80.7)	63.6 (50.9 to 75.1)	67.7 (54.7 to 79.1)	68.2 (55.6 to 79.1)	66.7 (44.7 to 84.4)
Day 211	60.6 (48.3 to 72.0)	53.0 (40.3 to 65.4)	50.0 (37.2 to 62.8)	53.0 (40.3 to 65.4)	52.2 (30.6 to 73.2)
Day 393	34.3 (23.3 to 46.6)	32.3 (21.2 to 45.1)	34.9 (23.3 to 48.0)	36.9 (25.3 to 49.8)	34.8 (16.4 to 57.3)

SecondaryGMT 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
Reported as:: Geometric mean · titer

GMT of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA)
titer	Arm 1: NoV Vaccine Formulation A_1-Dose	Arm 2: NoV Vaccine Formulation A_2-Dose	Arm 3: NoV Vaccine Formulation B_1-Dose	Arm 4: NoV Vaccine Formulation B_2-Dose	Arm 5: NoV Vaccine Formulation A_1-Dose
Baseline (Day 1)	661.8 (508.5 to 861.2)	906.1 (622.4 to 1319.3)	838.5 (605.8 to 1160.4)	619.7 (459.7 to 835.2)	460.3 (204.8 to 1034.6)
Day 8	678.0 (519.7 to 884.5)	4534.9 (3303.2 to 6225.8)	829.4 (603.0 to 1140.8)	6382.8 (4698.1 to 8671.7)	455.2 (192.4 to 1076.7)
Day 29	668.2 (520.4 to 857.9)	7701.1 (6141.9 to 9656.0)	791.9 (585.7 to 1070.9)	8951.5 (7127.3 to 11242.6)	574.0 (273.1 to 1206.2)
Day 36	4158.6 (3095.1 to 5587.6)	7663.6 (6165.5 to 9525.6)	6411.8 (4795.4 to 8573.1)	9161.1 (7501.2 to 11188.4)	7603.5 (4590.2 to 12595.1)
Day 57	6183.5 (4929.9 to 7755.8)	7235.1 (5945.9 to 8804.0)	8838.3 (6928.3 to 11275.0)	8182.2 (6751.1 to 9916.8)	8165.5 (5659.8 to 11780.6)
Day 211	3945.2 (3233.5 to 4813.6)	5161.2 (4206.5 to 6332.6)	5406.6 (4433.7 to 6593.0)	4882.3 (4069.9 to 5856.9)	3523.2 (2277.6 to 5449.9)
Day 393	2903.4 (2307.1 to 3653.9)	3672.1 (2835.7 to 4755.2)	3862.9 (3060.2 to 4876.3)	3370.0 (2799.0 to 4057.5)	2252.6 (1365.3 to 3716.5)

SecondaryGMT 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
Reported as:: Geometric mean · titer

GMT of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA)
titer	Arm 1: NoV Vaccine Formulation A_1-Dose	Arm 2: NoV Vaccine Formulation A_2-Dose	Arm 3: NoV Vaccine Formulation B_1-Dose	Arm 4: NoV Vaccine Formulation B_2-Dose	Arm 5: NoV Vaccine Formulation A_1-Dose
Baseline (Day 1)	761.9 (547.9 to 1059.7)	1054.9 (707.8 to 1572.4)	1066.3 (719.7 to 1580.0)	897.4 (612.3 to 1315.3)	1023.2 (543.8 to 1925.3)
Day 8	766.6 (553.1 to 1062.6)	4725.5 (3479.7 to 6417.3)	1078.9 (726.6 to 1602.0)	5691.9 (4107.9 to 7886.7)	1054.6 (550.6 to 2020.2)
Day 29	766.8 (553.7 to 1062.0)	8105.1 (6053.8 to 10851.6)	1017.7 (690.1 to 1500.8)	8314.1 (6388.3 to 10820.3)	1022.4 (574.4 to 1819.7)
Day 36	4587.6 (3402.2 to 6186.0)	7911.9 (6059.9 to 10329.8)	5411.9 (3777.0 to 7754.5)	8025.5 (6339.1 to 10160.5)	10084.9 (7037.2 to 14452.5)
Day 57	6564.1 (5151.3 to 8364.5)	7489.2 (5788.1 to 9690.4)	7877.2 (5878.8 to 10554.9)	7028.4 (5611.6 to 8803.0)	9507.3 (7110.9 to 12711.2)
Day 211	3702.0 (2913.0 to 4704.7)	4915.8 (3676.9 to 6572.2)	4657.8 (3510.6 to 6179.8)	4456.2 (3493.1 to 5684.9)	4531.5 (3194.5 to 6428.0)
Day 393	2216.7 (1708.9 to 2875.3)	3151.5 (2319.8 to 4281.5)	2807.4 (2081.9 to 3785.8)	2853.9 (2225.5 to 3659.7)	2969.5 (1818.4 to 4849.5)

SecondaryGMFR 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
Reported as:: Geometric mean · ratio

GMFR of Anti-norovirus GI.1 VLP Antibody Titers (Pan-Ig ELISA)
ratio	Arm 1: NoV Vaccine Formulation A_1-Dose	Arm 2: NoV Vaccine Formulation A_2-Dose	Arm 3: NoV Vaccine Formulation B_1-Dose	Arm 4: NoV Vaccine Formulation B_2-Dose	Arm 5: NoV Vaccine Formulation A_1-Dose
Day 8	1.0 (1.0 to 1.1)	5.1 (3.7 to 7.2)	1.0 (0.9 to 1.0)	10.3 (7.2 to 14.7)	1.0 (0.9 to 1.1)
Day 29	1.0 (0.9 to 1.1)	8.5 (6.2 to 11.7)	0.9 (0.9 to 1.0)	14.4 (10.7 to 19.5)	1.2 (0.9 to 1.8)
Day 36	6.3 (4.5 to 8.8)	8.5 (6.1 to 11.7)	7.6 (5.5 to 10.6)	14.8 (10.9 to 20.0)	17.3 (8.4 to 35.9)
Day 57	9.0 (6.8 to 11.9)	7.9 (5.8 to 10.8)	11.4 (8.3 to 15.6)	13.2 (9.9 to 17.7)	17.7 (8.8 to 35.8)
Day 211	6.0 (4.8 to 7.5)	5.8 (4.3 to 7.7)	6.4 (4.9 to 8.5)	7.9 (6.2 to 10.0)	8.0 (4.1 to 15.4)
Day 393	4.4 (3.6 to 5.5)	4.0 (3.1 to 5.3)	4.6 (3.6 to 5.9)	5.2 (4.2 to 6.5)	5.1 (2.6 to 10.1)

SecondaryGMFR 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
Reported as:: Geometric mean · ratio

GMFR of Anti-norovirus GII.4 VLP Antibody Titers (Pan-Ig ELISA)
ratio	Arm 1: NoV Vaccine Formulation A_1-Dose	Arm 2: NoV Vaccine Formulation A_2-Dose	Arm 3: NoV Vaccine Formulation B_1-Dose	Arm 4: NoV Vaccine Formulation B_2-Dose	Arm 5: NoV Vaccine Formulation A_1-Dose
Day 8	1.0 (1.0 to 1.1)	4.5 (3.2 to 6.2)	1.0 (1.0 to 1.1)	6.3 (4.5 to 9.0)	1.0 (0.9 to 1.0)
Day 29	1.0 (0.9 to 1.1)	7.7 (5.7 to 10.4)	1.0 (0.9 to 1.0)	9.3 (6.7 to 12.8)	1.0 (0.9 to 1.1)
Day 36	6.0 (4.3 to 8.4)	7.5 (5.6 to 10.0)	5.0 (3.6 to 6.9)	8.9 (6.4 to 12.4)	9.6 (5.1 to 18.1)
Day 57	8.7 (6.4 to 11.7)	6.9 (5.2 to 9.2)	8.3 (6.2 to 11.0)	7.8 (5.8 to 10.6)	9.3 (5.1 to 16.8)
Day 211	4.9 (3.8 to 6.3)	4.6 (3.6 to 5.9)	4.5 (3.5 to 5.7)	5.0 (3.8 to 6.4)	4.7 (3.0 to 7.5)
Day 393	3.1 (2.4 to 3.8)	3.1 (2.4 to 3.9)	2.6 (2.1 to 3.3)	3.0 (2.4 to 3.8)	3.1 (1.9 to 5.0)

SecondaryPercentage 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
Reported as:: Number · percentage of participants

Percentage of Participants With At Least One Adverse Event of Special Interest (AESI)
percentage of participants	Arm 1: NoV Vaccine Formulation A_1-Dose	Arm 2: NoV Vaccine Formulation A_2-Dose	Arm 3: NoV Vaccine Formulation B_1-Dose	Arm 4: NoV Vaccine Formulation B_2-Dose	Arm 5: NoV Vaccine Formulation A_1-Dose
Percentage of Participants With At Least One Adverse Event of Special Interest (AESI)	1.3	2.7	2.8	0.0	0.0

SecondaryPercentage 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
Reported as:: Number · percentage of participants

Percentage of Participants With At Least One Adverse Event (AE) Leading to Participant's Withdrawal From the Study
percentage of participants	Arm 1: NoV Vaccine Formulation A_1-Dose	Arm 2: NoV Vaccine Formulation A_2-Dose	Arm 3: NoV Vaccine Formulation B_1-Dose	Arm 4: NoV Vaccine Formulation B_2-Dose	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	1.3	1.4	0.0	1.4	0.0

Adverse events

Collected over All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 393); Other adverse events: From any vaccination (Day 1 and Day 29) up to 28 days post vaccination.. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Arm 1: NoV Vaccine Formulation A_1-Dose	1/76 (1.3%)	7/76 (9.2%)	28/76 (36.8%)
Arm 2: NoV Vaccine Formulation A_2-Dose	1/74 (1.4%)	9/74 (12.2%)	25/74 (33.8%)
Arm 3: NoV Vaccine Formulation B_1-Dose	0/72 (0%)	17/72 (23.6%)	23/72 (31.9%)
Arm 4: NoV Vaccine Formulation B_2-Dose	1/72 (1.4%)	9/72 (12.5%)	21/72 (29.2%)
Arm 5: NoV Vaccine Formulation A_1-Dose	0/25 (0%)	0/25 (0%)	7/25 (28%)

Most frequent serious events

Showing 10 of 61

Most frequent serious events
Event	Arm 1: NoV Vaccine Formulation A_1-Dose	Arm 2: NoV Vaccine Formulation A_2-Dose	Arm 3: NoV Vaccine Formulation B_1-Dose	Arm 4: NoV Vaccine Formulation B_2-Dose	Arm 5: NoV Vaccine Formulation A_1-Dose
Atrial fibrillationCardiac disorders	1/76	0/74	2/72	1/72	0/25
Hip fractureInjury, poisoning and procedural complications	0/76	1/74	2/72	0/72	0/25
Haemorrhagic anaemiaBlood and lymphatic system disorders	0/76	0/74	1/72	0/72	0/25
Aortic valve stenosisCardiac disorders	1/76	0/74	1/72	0/72	0/25
Cardiac failure congestiveCardiac disorders	0/76	1/74	1/72	0/72	0/25
Acute coronary syndromeCardiac disorders	0/76	0/74	1/72	0/72	0/25
Acute myocardial infarctionCardiac disorders	0/76	0/74	0/72	1/72	0/25
Aortic valve incompetenceCardiac disorders	0/76	0/74	1/72	0/72	0/25
Atrial flutterCardiac disorders	0/76	0/74	1/72	0/72	0/25
Atrioventricular block second degreeCardiac disorders	0/76	0/74	1/72	0/72	0/25

Most frequent other events

Showing 10 of 29

Most frequent other events
Event	Arm 1: NoV Vaccine Formulation A_1-Dose	Arm 2: NoV Vaccine Formulation A_2-Dose	Arm 3: NoV Vaccine Formulation B_1-Dose	Arm 4: NoV Vaccine Formulation B_2-Dose	Arm 5: NoV Vaccine Formulation A_1-Dose
Upper respiratory tract infectionInfections and infestations	8/76	8/74	5/72	3/72	1/25
Viral upper respiratory tract infectionInfections and infestations	2/76	4/74	0/72	1/72	2/25
FatigueGeneral disorders	3/76	3/74	1/72	3/72	2/25
Injection site bruisingGeneral disorders	4/76	1/74	4/72	2/72	0/25
DiarrhoeaGastrointestinal disorders	4/76	3/74	2/72	0/72	0/25
MyalgiaMusculoskeletal and connective tissue disorders	1/76	0/74	3/72	1/72	0/25
HeadacheNervous system disorders	2/76	2/74	3/72	1/72	1/25
DizzinessNervous system disorders	1/76	1/74	3/72	0/72	0/25
ConjunctivitisInfections and infestations	0/76	0/74	0/72	0/72	1/25
NauseaGastrointestinal disorders	1/76	1/74	1/72	0/72	1/25

Baseline characteristics

Randomized Set included all randomized participants regardless of whether any study vaccine (NoV VLP vaccine or placebo) was received.

Age, Continuous
Age, Continuous(years)	Arm 1: NoV Vaccine Formulation A_1-Dose	Arm 2: NoV Vaccine Formulation A_2-Dose	Arm 3: NoV Vaccine Formulation B_1-Dose	Arm 4: NoV Vaccine Formulation B_2-Dose	Arm 5: NoV Vaccine Formulation A_1-Dose	Total
Mean	78.0 ± 9.14	77.4 ± 9.32	76.7 ± 9.22	77.7 ± 9.07	—	77.4 ± 9.15

Age, Continuous
Age, Continuous(years)	Arm 1: NoV Vaccine Formulation A_1-Dose	Arm 2: NoV Vaccine Formulation A_2-Dose	Arm 3: NoV Vaccine Formulation B_1-Dose	Arm 4: NoV Vaccine Formulation B_2-Dose	Arm 5: NoV Vaccine Formulation A_1-Dose	Total
Mean	—	—	—	—	34.6 ± 8.46	34.6 ± 8.46

Sex: Female, Male
Sex: Female, Male(Participants)	Arm 1: NoV Vaccine Formulation A_1-Dose	Arm 2: NoV Vaccine Formulation A_2-Dose	Arm 3: NoV Vaccine Formulation B_1-Dose	Arm 4: NoV Vaccine Formulation B_2-Dose	Arm 5: NoV Vaccine Formulation A_1-Dose	Total
Female	44	41	40	40	16	181
Male	32	33	32	32	10	139

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Arm 1: NoV Vaccine Formulation A_1-Dose	Arm 2: NoV Vaccine Formulation A_2-Dose	Arm 3: NoV Vaccine Formulation B_1-Dose	Arm 4: NoV Vaccine Formulation B_2-Dose	Arm 5: NoV Vaccine Formulation A_1-Dose	Total
Hispanic or Latino	4	6	3	4	2	19
Not Hispanic or Latino	72	68	69	68	24	301
Unknown or Not Reported	0	0	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Arm 1: NoV Vaccine Formulation A_1-Dose	Arm 2: NoV Vaccine Formulation A_2-Dose	Arm 3: NoV Vaccine Formulation B_1-Dose	Arm 4: NoV Vaccine Formulation B_2-Dose	Arm 5: NoV Vaccine Formulation A_1-Dose	Total
American Indian or Alaska Native	0	0	0	0	0	0
Asian	2	0	1	2	2	7
Native Hawaiian or Other Pacific Islander	0	0	1	0	1	2
Black or African American	2	5	2	0	2	11
White	72	69	68	70	20	299
More than one race	0	0	0	0	1	1
Unknown or Not Reported	0	0	0	0	0	0

Region of Enrollment
Region of Enrollment(Participants)	Arm 1: NoV Vaccine Formulation A_1-Dose	Arm 2: NoV Vaccine Formulation A_2-Dose	Arm 3: NoV Vaccine Formulation B_1-Dose	Arm 4: NoV Vaccine Formulation B_2-Dose	Arm 5: NoV Vaccine Formulation A_1-Dose	Total
United States	76	74	72	72	26	320

Height
Height(cm)	Arm 1: NoV Vaccine Formulation A_1-Dose	Arm 2: NoV Vaccine Formulation A_2-Dose	Arm 3: NoV Vaccine Formulation B_1-Dose	Arm 4: NoV Vaccine Formulation B_2-Dose	Arm 5: NoV Vaccine Formulation A_1-Dose	Total
Mean	166.8 ± 9.95	167.3 ± 9.52	168.0 ± 9.17	167.4 ± 10.26	—	167.3 ± 9.69

Height
Height(cm)	Arm 1: NoV Vaccine Formulation A_1-Dose	Arm 2: NoV Vaccine Formulation A_2-Dose	Arm 3: NoV Vaccine Formulation B_1-Dose	Arm 4: NoV Vaccine Formulation B_2-Dose	Arm 5: NoV Vaccine Formulation A_1-Dose	Total
Mean	—	—	—	—	169.4 ± 11.42	169.4 ± 11.42

4 further baseline measures are reported on the registry.

Study locations

10 sites

Simon Williamson Clinic
Birmingham, Alabama 35211, United States
Fountain Hills Family Practice, P.C.
Fountain Hills, Arizona 85268, United States
Southwest Family Medicine
Littleton, Colorado 80127, United States
Miami Research Associates
Miami, Florida 33143, United States
Johnson County Clin-Trials
Lenexa, Kansas 66219, United States
St. Louis University, School of Medicine
Saint Louis, Missouri 63104, United States
Regional Clinical Research Inc.
Endwell, New York 13760, United States
University of Rochester
Rochester, New York 14642, United States
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio 45229-3039, United States
Group Health Research Institute
Seattle, Washington 98101, United States

References and documents

Study documents

Statistical analysis plan · Feb 2, 2017
Study protocol · Nov 16, 2015

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02661490
Lead sponsor: Takeda
Responsible party: Sponsor
First posted: Jan 22, 2016
Start date: Feb 1, 2016
Primary completion: Oct 28, 2016
Completion: Sep 29, 2017
Results posted: May 18, 2020
Last update: May 18, 2020

Study contacts

Medical Director Clinical Science

study director · Takeda

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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