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Trial record 63 of 141 for:    MPL

Safety and Immunogenicity of Norovirus Bivalent Virus-Like Particle Vaccine in Healthy Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02142504
Recruitment Status : Completed
First Posted : May 20, 2014
Results First Posted : February 23, 2017
Last Update Posted : August 21, 2017
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Norovirus Prevention
Interventions Biological: Norovirus Bivalent VLP Vaccine
Drug: Placebo (Saline)
Enrollment 454
Recruitment Details Participants took part in the study at 10 investigative sites in the United States from 28 April 2014 to 14 January 2016.
Pre-assignment Details Healthy volunteers were enrolled equally in 1 of 3 norovirus bivalent virus like particle (VLP) vaccine unique formulation treatment groups to receive: 2 formulation arms received 2 doses and 1 formulation arm received 1 dose.
Arm/Group Title Saline Placebo + GI.1/GII.4 15/15 μg (No MPL) GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL) GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
Hide Arm/Group Description Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365. IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365. IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
Period Title: Overall Study
Started 153 147 154
Randomized and Received Treatment 153 145 154
Received Booster (Second Vaccination) 126 109 116
Completed 122 105 111
Not Completed 31 42 43
Reason Not Completed
Protocol Violation             2             1             2
Adverse Event             2             3             4
Lost to Follow-up             12             19             17
Withdrawal by Subject             7             9             11
Pregnancy             4             4             2
Physician Decision             0             1             3
Reason Not Specified             4             5             4
Arm/Group Title Saline Placebo + GI.1/GII.4 15/15 μg (No MPL) GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL) GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL) Total
Hide Arm/Group Description Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365. IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365. IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365. Total of all reporting groups
Overall Number of Baseline Participants 153 147 154 454
Hide Baseline Analysis Population Description
Randomized Set included all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 153 participants 147 participants 154 participants 454 participants
32.9  (8.87) 33.4  (9.26) 34.0  (8.78) 33.5  (8.96)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 153 participants 147 participants 154 participants 454 participants
Female
89
  58.2%
89
  60.5%
75
  48.7%
253
  55.7%
Male
64
  41.8%
58
  39.5%
79
  51.3%
201
  44.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 153 participants 147 participants 154 participants 454 participants
Hispanic or Latino 34 38 46 118
Non-Hispanic and Latino 117 109 107 333
Not Reported 1 0 1 2
Unknown 1 0 0 1
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 153 participants 147 participants 154 participants 454 participants
American Indian or Alaska Native 0 0 2 2
Asian 5 3 2 10
Black or African American 41 49 47 137
Native Hawaiian or Other Pacific Islander 3 2 2 7
White 100 91 94 285
Other 1 1 2 4
Multiracial 3 1 5 9
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 153 participants 147 participants 154 participants 454 participants
153 147 154 454
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 153 participants 147 participants 154 participants 454 participants
169.91  (9.228) 168.89  (9.670) 171.24  (9.859) 170.03  (9.616)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 153 participants 147 participants 154 participants 454 participants
76.50  (14.924) 75.56  (14.720) 76.91  (15.598) 76.33  (15.068)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 153 participants 147 participants 154 participants 454 participants
26.40  (4.125) 26.44  (4.427) 26.14  (4.313) 26.32  (4.281)
1.Primary Outcome
Title Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After the First Injection
Hide Description Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occurred within 7 days after the primary injection.
Time Frame Days 1 through 7
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set included all participants who received at least one dose of trial vaccination.
Arm/Group Title Saline Placebo + GI.1/GII.4 15/15 μg (No MPL) GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL) GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
Hide Arm/Group Description:
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
Overall Number of Participants Analyzed 153 145 154
Measure Type: Number
Unit of Measure: percentage of participants
Any Solicited Local AEs 7.8 64.1 72.7
Pain 7.8 64.1 72.7
Erythema 0 0 0.6
Induration 0 1.4 1.3
Swelling 0 2.1 0.6
2.Primary Outcome
Title Percentage of Participants With Solicited Systemic Adverse Events (AEs) After the First Injection
Hide Description Solicited systemic AEs are defined as: headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea that occurred within 7 days after the primary injection.
Time Frame Days 1 through 7
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set included all participants who received at least one dose of trial vaccination.
Arm/Group Title Saline Placebo + GI.1/GII.4 15/15 μg (No MPL) GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL) GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
Hide Arm/Group Description:
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
Overall Number of Participants Analyzed 153 145 154
Measure Type: Number
Unit of Measure: percentage of participants
Any Solicited Systemic AEs 26.8 33.1 45.5
Headache 16.3 15.9 18.2
Fatigue 17.0 15.9 16.2
Myalgia 7.2 19.3 25.3
Arthralgia 3.3 4.8 7.8
Vomiting 1.3 1.4 1.9
Diarrhea 7.8 7.6 10.4
3.Primary Outcome
Title Percentage of Participants With Elevated Daily Oral Temperature (Fever) After the First Injection
Hide Description Fever is defined as greater than or equal to 38°C (100.4°F). Oral body temperature measurement was performed using the thermometer provided by the site for 7 days after each injection. The highest body temperature observed each day was recorded on the Diary Card also provided by the site.
Time Frame Days 1 through 7
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set included all participants who received at least one dose of trial vaccination.
Arm/Group Title Saline Placebo + GI.1/GII.4 15/15 μg (No MPL) GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL) GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
Hide Arm/Group Description:
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
Overall Number of Participants Analyzed 153 145 154
Measure Type: Number
Unit of Measure: percentage of participants
0 0.7 0
4.Primary Outcome
Title Percentage of Participants With Unsolicited Adverse Events (AEs) After the First Injection
Hide Description Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study.
Time Frame Days 1 through 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set included all participants who received at least one dose of trial vaccination.
Arm/Group Title Saline Placebo + GI.1/GII.4 15/15 μg (No MPL) GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL) GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
Hide Arm/Group Description:
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
Overall Number of Participants Analyzed 153 145 154
Measure Type: Number
Unit of Measure: percentage of participants
23.5 16.6 21.4
5.Primary Outcome
Title Percentage of Participants With Serious Adverse Events (SAEs) After the First Injection
Hide Description A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
Time Frame From first injection (Day 1) to second injection pre-dose (Up to Day 365)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set included all participants who received at least one dose of trial vaccination.
Arm/Group Title Saline Placebo + GI.1/GII.4 15/15 μg (No MPL) GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL) GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
Hide Arm/Group Description:
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
Overall Number of Participants Analyzed 153 145 154
Measure Type: Number
Unit of Measure: percentage of participants
1.3 2.1 3.2
6.Primary Outcome
Title Percentage of Participants With Serious Adverse Events (SAEs) After the Second Injection
Hide Description A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
Time Frame From second injection (Day 365) to 6 months after second injection (Up to Day 545)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Safety Analysis Set who received a second injection.
Arm/Group Title Saline Placebo + GI.1/GII.4 15/15 μg (No MPL) GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL) GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
Hide Arm/Group Description:
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
Overall Number of Participants Analyzed 126 109 116
Measure Type: Number
Unit of Measure: percentage of participants
1.6 0.9 0.9
7.Primary Outcome
Title Percentage of Participants With Adverse Events of Special Interest (AESI) After the First Injection
Hide Description 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 injection (Day 1) to second injection pre-dose (Up to Day 365)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set included all participants who received at least one dose of trial vaccination.
Arm/Group Title Saline Placebo + GI.1/GII.4 15/15 μg (No MPL) GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL) GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
Hide Arm/Group Description:
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
Overall Number of Participants Analyzed 153 145 154
Measure Type: Number
Unit of Measure: percentage of participants
1.3 2.1 1.3
8.Primary Outcome
Title Percentage of Participants With Adverse Events of Special Interest (AESI) After the Second Injection
Hide Description 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 second injection (Day 365) to 6 months after second injection (Up to Day 545)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Safety Analysis Set who received a second injection.
Arm/Group Title Saline Placebo + GI.1/GII.4 15/15 μg (No MPL) GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL) GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
Hide Arm/Group Description:
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
Overall Number of Participants Analyzed 126 109 116
Measure Type: Number
Unit of Measure: percentage of participants
3.2 0 0.9
9.Primary Outcome
Title Percentage of Participants With Any Adverse Event (AE) Leading to Withdrawal From the Study
Hide Description Withdrawal due to an AE occurred if the participant experienced an AE that required early termination because continued participation imposed an unacceptable risk to the participant's health or the participant was unwilling to continue because of the AE.
Time Frame Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set included all participants who received at least one dose of trial vaccination.
Arm/Group Title Saline Placebo + GI.1/GII.4 15/15 μg (No MPL) GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL) GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
Hide Arm/Group Description:
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
Overall Number of Participants Analyzed 153 145 154
Measure Type: Number
Unit of Measure: percentage of participants
1.3 1.4 2.6
10.Secondary Outcome
Title Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After the Second Injection
Hide Description Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occurred within 7 days after the vaccination on Day 365.
Time Frame Days 365 through 371
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Safety Analysis Set who received a second injection.
Arm/Group Title Saline Placebo + GI.1/GII.4 15/15 μg (No MPL) GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL) GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
Hide Arm/Group Description:
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
Overall Number of Participants Analyzed 126 109 116
Measure Type: Number
Unit of Measure: percentage of participants
Any Solicited Local AEs 41.3 41.3 44.0
Pain 41.3 41.3 44.0
Erythema 0.8 0.9 0
Induration 0 0 0
Swelling 0 2.8 0
11.Secondary Outcome
Title Percentage of Participants With Solicited Systemic Adverse Events (AEs) After the Second Injection
Hide Description Solicited systemic AEs are defined as: headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea that occurred within 7 days after the vaccination on Day 365.
Time Frame Days 365 through 371
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Safety Analysis Set who received a second injection.
Arm/Group Title Saline Placebo + GI.1/GII.4 15/15 μg (No MPL) GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL) GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
Hide Arm/Group Description:
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
Overall Number of Participants Analyzed 126 109 116
Measure Type: Number
Unit of Measure: percentage of participants
Any Solicited Systemic AEs 28.6 25.7 31.9
Headache 11.9 11.0 14.7
Fatigue 11.1 14.7 17.2
Myalgia 15.1 15.6 14.7
Arthralgia 0.8 7.3 6.0
Vomiting 2.4 1.8 1.7
Diarrhea 4.0 7.3 8.6
12.Secondary Outcome
Title Percentage of Participants With Elevated Daily Oral Temperature (Fever) After the Second Injection
Hide Description Fever is defined as greater than or equal to 38°C (100.4°F). Oral body temperature measurement was performed using the thermometer provided by the site for 7 days after each vaccination. The highest body temperature observed each day was recorded on the Diary Card also provided by the site.
Time Frame Days 365 through 371
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Safety Analysis Set who received a second injection.
Arm/Group Title Saline Placebo + GI.1/GII.4 15/15 μg (No MPL) GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL) GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
Hide Arm/Group Description:
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
Overall Number of Participants Analyzed 126 109 116
Measure Type: Number
Unit of Measure: percentage of participants
0 0.9 2.6
13.Secondary Outcome
Title Percentage of Participants With Unsolicited Adverse Events (AEs) After the Second Injection
Hide Description Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study.
Time Frame Days 365 through 393
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Safety Analysis Set who received a second injection.
Arm/Group Title Saline Placebo + GI.1/GII.4 15/15 μg (No MPL) GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL) GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
Hide Arm/Group Description:
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
Overall Number of Participants Analyzed 126 109 116
Measure Type: Number
Unit of Measure: percentage of participants
20.6 14.7 14.7
14.Secondary Outcome
Title Percentage of Participants With a Seroresponse in Both Serum Anti-norovirus GI.1 VLP and GII.4 VLP (Pan-Ig ELISA)
Hide Description Seroresponse is defined as 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 virus-Like particle (VLP) and GII.4 VLP as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).
Time Frame Baseline and Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.
Arm/Group Title Saline Placebo + GI.1/GII.4 15/15 μg (No MPL) GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL) GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
Hide Arm/Group Description:
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
Overall Number of Participants Analyzed 151 140 151
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
2.6
(0.7 to 6.6)
70.7
(62.4 to 78.1)
64.9
(56.7 to 72.5)
15.Secondary Outcome
Title Percentage of Participants With a Seroresponse in Serum Anti-norovirus GI.1 VLP (Pan-Ig ELISA)
Hide Description Seroresponse is defined as 4-fold rise or greater in serum anti-norovirus antibody titers for GI.1 virus-Like particle (VLP) as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).
Time Frame Baseline and Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.
Arm/Group Title Saline Placebo + GI.1/GII.4 15/15 μg (No MPL) GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL) GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
Hide Arm/Group Description:
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
Overall Number of Participants Analyzed 151 140 151
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
8.6
(4.7 to 14.3)
91.4
(85.5 to 95.5)
90.1
(84.1 to 94.3)
16.Secondary Outcome
Title Percentage of Participants With a Seroresponse in Serum Anti-norovirus GII.4 VLP (Pan-Ig ELISA)
Hide Description Seroresponse is defined as 4-fold rise or greater in serum anti-norovirus antibody titers for GII.4 virus-like particles (VLP) as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA).
Time Frame Baseline and Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.
Arm/Group Title Saline Placebo + GI.1/GII.4 15/15 μg (No MPL) GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL) GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
Hide Arm/Group Description:
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
Overall Number of Participants Analyzed 151 140 151
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
4.6
(1.9 to 9.3)
75.0
(67.0 to 81.9)
69.5
(61.5 to 76.8)
17.Secondary Outcome
Title Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)
Hide Description Geometric mean titer (GMT) of anti-norovirus GI.1 VLP antibody titers as measured by Pan-Ig ELISA.
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.
Arm/Group Title Saline Placebo + GI.1/GII.4 15/15 μg (No MPL) GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL) GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
Hide Arm/Group Description:
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
Overall Number of Participants Analyzed 151 140 151
Geometric Mean (Standard Deviation)
Unit of Measure: titer
366.8  (6.29) 13023.2  (3.40) 18711.8  (3.84)
18.Secondary Outcome
Title Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)
Hide Description Geometric mean titer (GMT) of anti-norovirus GII.4 VLP antibody titers as measured by Pan-Ig ELISA.
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.
Arm/Group Title Saline Placebo + GI.1/GII.4 15/15 μg (No MPL) GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL) GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
Hide Arm/Group Description:
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
Overall Number of Participants Analyzed 151 140 151
Geometric Mean (Standard Deviation)
Unit of Measure: titer
955.5  (5.08) 11275.5  (2.38) 8667.9  (2.84)
19.Secondary Outcome
Title Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)
Hide Description Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by Pan-Ig ELISA.
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.
Arm/Group Title Saline Placebo + GI.1/GII.4 15/15 μg (No MPL) GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL) GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
Hide Arm/Group Description:
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
Overall Number of Participants Analyzed 151 140 151
Geometric Mean (Standard Deviation)
Unit of Measure: ratio
1.3  (3.81) 37.6  (6.11) 55.9  (5.90)
20.Secondary Outcome
Title Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)
Hide Description Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by Pan-Ig ELISA.
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.
Arm/Group Title Saline Placebo + GI.1/GII.4 15/15 μg (No MPL) GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL) GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
Hide Arm/Group Description:
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
Overall Number of Participants Analyzed 151 140 151
Geometric Mean (Standard Deviation)
Unit of Measure: ratio
1.1  (2.08) 10.7  (4.35) 7.4  (3.46)
21.Secondary Outcome
Title Percentage of Participants With a Seroresponse in Both Serum Anti-norovirus GI.1 VLP and GII.4 VLP (HBGA)
Hide Description Seroresponse is defined as 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 virus-Like particle (VLP) and GII.4 VLP as measured by histoblood group antigen (HBGA) binding assay.
Time Frame Baseline and Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Per Protocol Set, all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations, with data available for this outcome measure.
Arm/Group Title Saline Placebo + GI.1/GII.4 15/15 μg (No MPL) GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL) GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
Hide Arm/Group Description:
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
Overall Number of Participants Analyzed 151 139 151
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
2.0
(0.4 to 5.7)
55.4
(46.7 to 63.8)
55.0
(46.7 to 63.1)
22.Secondary Outcome
Title Percentage of Participants With a Seroresponse in Serum GI.1 VLP Antibody Titers (HBGA)
Hide Description Seroresponse is defined as 4-fold rise or greater in serum anti-norovirus antibody titers for GI.1 virus-Like particle (VLP) as measured by HBGA binding assay.
Time Frame Baseline and Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.
Arm/Group Title Saline Placebo + GI.1/GII.4 15/15 μg (No MPL) GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL) GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
Hide Arm/Group Description:
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
Overall Number of Participants Analyzed 151 140 151
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
3.3
(1.1 to 7.6)
74.3
(66.2 to 81.3)
80.8
(73.6 to 86.7)
23.Secondary Outcome
Title Percentage of Participants With a Seroresponse in Serum GII.4 VLP Antibody Titers (HBGA)
Hide Description Seroresponse is defined as 4-fold rise or greater in serum anti-norovirus antibody titers for GII.4 virus-Like particle (VLP) as measured by HBGA binding assay.
Time Frame Baseline and Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Per Protocol Set, all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations, with data for this outcome measure
Arm/Group Title Saline Placebo + GI.1/GII.4 15/15 μg (No MPL) GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL) GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
Hide Arm/Group Description:
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
Overall Number of Participants Analyzed 151 139 151
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
2.6
(0.7 to 6.6)
71.2
(62.9 to 78.6)
68.2
(60.1 to 75.5)
24.Secondary Outcome
Title Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)
Hide Description Blocking titers 50 (BT50) of anti-norovirus GI.1 VLP antibody titers as measured by HBGA binding assay.
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.
Arm/Group Title Saline Placebo + GI.1/GII.4 15/15 μg (No MPL) GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL) GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
Hide Arm/Group Description:
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
Overall Number of Participants Analyzed 151 140 151
Geometric Mean (Standard Deviation)
Unit of Measure: titer
20.7  (2.38) 170.9  (3.90) 207.8  (3.94)
25.Secondary Outcome
Title Blocking Titers 50 (BT50) of Anti-Norovirus GII.4 VLP Antibody Titers (HBGA)
Hide Description Blocking titers 50 (BT50) of anti-norovirus GII.4 VLP antibody titers as measured by HBGA binding assay.
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Per Protocol Set, all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations, with data available for this outcome measure.
Arm/Group Title Saline Placebo + GI.1/GII.4 15/15 μg (No MPL) GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL) GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
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Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
Overall Number of Participants Analyzed 151 139 151
Geometric Mean (Standard Deviation)
Unit of Measure: titer
80.1  (4.33) 804.3  (3.32) 631.3  (3.05)
26.Secondary Outcome
Title Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)
Hide Description Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by HBGA binding assay.
Time Frame Day 28
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Hide Analysis Population Description
Per Protocol Set included all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations.
Arm/Group Title Saline Placebo + GI.1/GII.4 15/15 μg (No MPL) GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL) GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
Hide Arm/Group Description:
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
Overall Number of Participants Analyzed 151 140 151
Geometric Mean (Standard Deviation)
Unit of Measure: ratio
1.1  (1.69) 8.9  (3.64) 10.5  (3.56)
27.Secondary Outcome
Title Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)
Hide Description Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by the HBGA binding assay.
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Per Protocol Set, all participants in Full Analysis Set, who had evaluable blood samples at baseline, and Day 28 within the specified window (+/- 7 days), and did not have major protocol violations, with data available for this outcome measure.
Arm/Group Title Saline Placebo + GI.1/GII.4 15/15 μg (No MPL) GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL) GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
Hide Arm/Group Description:
Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
Overall Number of Participants Analyzed 151 139 151
Geometric Mean (Standard Deviation)
Unit of Measure: ratio
1.0  (1.77) 9.7  (4.03) 7.3  (3.23)
Time Frame Unsolicited AEs 28 days after each injection (Days 1 to 28 and Days 365 to 393), and Serious Adverse Events (SAEs) throughout the trial (Up to Day 545)
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
 
Arm/Group Title Saline Placebo + GI.1/GII.4 15/15 μg (No MPL) GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL) GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
Hide Arm/Group Description Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365. IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365. IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
All-Cause Mortality
Saline Placebo + GI.1/GII.4 15/15 μg (No MPL) GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL) GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Saline Placebo + GI.1/GII.4 15/15 μg (No MPL) GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL) GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/153 (2.61%)   4/145 (2.76%)   6/154 (3.90%) 
Cardiac disorders       
Cardiac arrest  1  0/153 (0.00%)  1/145 (0.69%)  0/154 (0.00%) 
Endocrine disorders       
Basedow's disease  1  0/153 (0.00%)  0/145 (0.00%)  1/154 (0.65%) 
Eye disorders       
Retinal detachment  1  1/153 (0.65%)  0/145 (0.00%)  0/154 (0.00%) 
General disorders       
Injection site pain  1  0/153 (0.00%)  0/145 (0.00%)  1/154 (0.65%) 
Infections and infestations       
Kidney infection  1  0/153 (0.00%)  1/145 (0.69%)  0/154 (0.00%) 
Sepsis  1  0/153 (0.00%)  1/145 (0.69%)  0/154 (0.00%) 
Urinary tract infection  1  0/153 (0.00%)  1/145 (0.69%)  0/154 (0.00%) 
Injury, poisoning and procedural complications       
Hip fracture  1  0/153 (0.00%)  0/145 (0.00%)  1/154 (0.65%) 
Intentional overdose  1  0/153 (0.00%)  1/145 (0.69%)  0/154 (0.00%) 
Pelvic fracture  1  0/153 (0.00%)  0/145 (0.00%)  1/154 (0.65%) 
Rib fracture  1  1/153 (0.65%)  0/145 (0.00%)  0/154 (0.00%) 
Road traffic accident  1  0/153 (0.00%)  0/145 (0.00%)  1/154 (0.65%) 
Musculoskeletal and connective tissue disorders       
Musculoskeletal pain  1  0/153 (0.00%)  0/145 (0.00%)  1/154 (0.65%) 
Nervous system disorders       
Migraine  1  0/153 (0.00%)  1/145 (0.69%)  0/154 (0.00%) 
Neuralgic amyotrophy  1  0/153 (0.00%)  0/145 (0.00%)  1/154 (0.65%) 
Pregnancy, puerperium and perinatal conditions       
Abortion spontaneous  1  1/153 (0.65%)  1/145 (0.69%)  1/154 (0.65%) 
Psychiatric disorders       
Depression  1  0/153 (0.00%)  1/145 (0.69%)  1/154 (0.65%) 
Post-traumatic stress disorder  1  0/153 (0.00%)  0/145 (0.00%)  1/154 (0.65%) 
Schizophrenia  1  1/153 (0.65%)  0/145 (0.00%)  0/154 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Saline Placebo + GI.1/GII.4 15/15 μg (No MPL) GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL) GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   33/153 (21.57%)   24/145 (16.55%)   25/154 (16.23%) 
Gastrointestinal disorders       
Nausea  1  7/153 (4.58%)  3/145 (2.07%)  5/154 (3.25%) 
Diarrhoea  1  3/153 (1.96%)  4/145 (2.76%)  3/154 (1.95%) 
Abdominal pain upper  1  3/153 (1.96%)  3/145 (2.07%)  1/154 (0.65%) 
General disorders       
Fatigue  1  2/153 (1.31%)  1/145 (0.69%)  4/154 (2.60%) 
Injection site bruising  1  4/153 (2.61%)  1/145 (0.69%)  0/154 (0.00%) 
Injection site pain  1  0/153 (0.00%)  3/145 (2.07%)  1/154 (0.65%) 
Infections and infestations       
Nasopharyngitis  1  2/153 (1.31%)  4/145 (2.76%)  5/154 (3.25%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  4/153 (2.61%)  2/145 (1.38%)  2/154 (1.30%) 
Myalgia  1  1/153 (0.65%)  5/145 (3.45%)  2/154 (1.30%) 
Pain in extremity  1  3/153 (1.96%)  0/145 (0.00%)  4/154 (2.60%) 
Nervous system disorders       
Headache  1  11/153 (7.19%)  5/145 (3.45%)  10/154 (6.49%) 
Dizziness  1  2/153 (1.31%)  3/145 (2.07%)  1/154 (0.65%) 
Sinus headache  1  2/153 (1.31%)  0/145 (0.00%)  4/154 (2.60%) 
Respiratory, thoracic and mediastinal disorders       
Oropharyngeal pain  1  4/153 (2.61%)  1/145 (0.69%)  2/154 (1.30%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Results Point of Contact
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02142504     History of Changes
Other Study ID Numbers: NOR-201
U1111-1155-8803 ( Other Identifier: World Health Organization )
First Submitted: May 9, 2014
First Posted: May 20, 2014
Results First Submitted: January 3, 2017
Results First Posted: February 23, 2017
Last Update Posted: August 21, 2017