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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001419-64 | EudraCT Number | ||
| U1111-1147-3239 | Other Identifier | WHO |
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The purpose of this study is to select the optimal formulation of the norovirus vaccine from different concentrations of virus-like particles (VLP), Aluminum Hydroxide and MPL adjuvant (3-O-desacyl-4'-monophosphoryl lipid A) for further development.
The vaccine being tested in this study is called norovirus GI.1/GII.4 bivalent virus-like particle (VLP) vaccine adjuvanted with aluminum hydroxide and with or without monophosphoryl lipid A (MPL). The norovirus vaccine is being tested to assess different formulations of the vaccine that will then be further developed.
This study will look at the number of antibodies to norovirus formed in people who take different formulations of the norovirus vaccine. The study will enroll approximately 420 patients. Participants will be randomly assigned (by chance) to one of fourteen treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need).
All participants will receive a vaccination on Day 1 and Day 28 of the study. Some treatment arms will receive one dose of the norovirus vaccine and some arms will receive two. In order to keep the treatment arms undisclosed to the patient and the doctor, those randomized to the one dose groups will receive a dose of Hepatitis A vaccine on Day 1 followed by the norovirus vaccine 28 days later. Participants will be asked to record any symptoms that may be related to the vaccine or the injection site in a diary card for 7 days after each vaccination.
This multi-centre trial will be conducted in Belgium. The overall time to participate in this study is up to 393 days. Participants will make 6 visits to the clinic, and will be contacted by telephone twice for follow-up assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GI.1/GII.4 (15/15) - MPL (50) | Experimental | Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28. |
|
| GI.1/GII.4 (15/50) - MPL (50) | Experimental | Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28. |
|
| GI.1/GII.4 (50/50) - MPL (50) | Experimental | Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28. |
|
| GI.1/GII.4 (15/15) - MPL (15) | Experimental | Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hepatitis A Vaccine | Biological | Hepatitis A Vaccine IM injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Seroresponse (Pan-Ig ELISA) | Seroresponse was defined as 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 virus-Like particle (VLP) and GII.4 VLP as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA). | Baseline and Day 56 |
| Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1 | Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occurred within 7 days after each vaccination. | Days 1 through 7 |
| Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2 | Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occurred within 7 days after each vaccination. | Days 28 through 34 |
| Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1 | Solicited systemic AEs are defined as: headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea that occurred within 7 days after each vaccination. | Days 1 through 7 |
| Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2 | Solicited systemic AEs are defined as: headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea that occurred within 7 days after each vaccination. | Days 28 through 34 |
| Oral Body Temperature Within 7 Days After Dose 1 | Oral body temperature measurement is to be performed using the thermometer provided by the site for 7 days after each vaccination. The highest body temperature observed each day will be recorded on the Diary Card also provided by the site. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA) | Seroresponse was defined as 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 virus-Like particle (VLP) and GII.4 VLP as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA). D=Day | Baseline and Days 28, 208 and 393 |
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Inclusion Criteria:
Exclusion Criteria:
Has received any vaccines containing Hepatitis A vaccine within the past 5 years.
Has contraindications, warnings, and/or precautions to vaccination with Havrix as specified within the Summary of Product Characteristics.
Has a clinically significant active infection (as assessed by the investigator) or oral body temperature 38°C (100.4°F) or higher within 3 days of the intended date of vaccination.
Has received antipyretic/analgesic medications within 24 hours prior to the intended vaccine administration.
Known hypersensitivity or allergy to investigational vaccine (including excipients of the investigational vaccine).
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.
Has a history of any progressive or severe neurologic disorder, seizure disorder, or Guillain-Barré syndrome.
Has history of any illness that, in the opinion of the investigator, might interfere with the results of the trial or pose additional risk to the participants due to participation in the trial.
Known or inspected impairment/alteration of immune function, including the following:
Abnormalities of splenic or thymic function.
Has a known bleeding diathesis or any condition that may be associated with a prolonged bleeding time.
Has any serious chronic or progressive disease according to judgment of the investigator (eg, neoplasm, insulin dependent diabetes, cardiac, renal, or hepatic disease).
Has a body mass index (BMI) greater than or equal to 35 kg/m^2 (=weight in kg/[height in meters * height in meters]).
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.
Has received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this trial or who are planning to receive any vaccine within 28 days of investigational vaccine administration.
Is first degree relatives of individuals involved in trial conduct.
Has history of substance or alcohol abuse within the past 2 years.
If female, of childbearing potential, sexually active, and has not used any of the acceptable contraceptive methods for at least 2 months prior to trial entry.
Female participants of childbearing potential and sexually active, who refuse to use an acceptable contraceptive method from Day 1 through 6 months after the last dose of investigational vaccine.
Female participants who plan to donate ova from Day 1 through 6 months after the last dose of investigational vaccine.
Female participants with any positive pregnancy test.
Female participants who are pregnant or breastfeeding.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director Clinical Science | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universiteit Antwerpen | Edegem | 2650 | Belgium | |||
| Universitair Ziekenhuis Gent |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29140444 | Derived | Leroux-Roels G, Cramer JP, Mendelman PM, Sherwood J, Clemens R, Aerssens A, De Coster I, Borkowski A, Baehner F, Van Damme P. Safety and Immunogenicity of Different Formulations of Norovirus Vaccine Candidate in Healthy Adults: A Randomized, Controlled, Double-Blind Clinical Trial. J Infect Dis. 2018 Jan 30;217(4):597-607. doi: 10.1093/infdis/jix572. |
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Healthy volunteers were enrolled equally in 1 of 14 unique formulation treatment groups: 11 formulation arms received 1 dose and 3 formulation arms received 2 doses.
Participants took part in the study at 2 investigative sites in Belgium from 28 March 2014 (first participants signed the informed consent form) to 19 June 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | GI.1/GII.4 (15/15) - MPL (50) | Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28. |
| FG001 | GI.1/GII.4 (15/50) - MPL (50) | Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28. |
| FG002 | GI.1/GII.4 (50/50) - MPL (50) | Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28. |
| FG003 | GI.1/GII.4 (15/15) - MPL (15) | Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28. |
| FG004 | GI.1/GII.4 (15/50) - MPL (15) | IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28. |
| FG005 | GI.1/GII.4 (50/50) - MPL (15) | Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28. |
| FG006 | GI.1/GII.4 (15/15) | Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28. |
| FG007 | GI.1/GII.4 (15/50) | Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28. |
| FG008 | GI.1/GII.4 (50/50) | Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28. |
| FG009 | GI.1/GII.4 (50/150) | Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28. |
| FG010 | GI.1/GII.4 (15/50) - Al(OH)3 (167) | Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28. |
| FG011 | GI.1/GII.4 (15/50) x2 | Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28. |
| FG012 | GI.1/GII.4 (50/150) x2 | Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28. |
| FG013 | GI.1/GII.4 (15/50) - Al(OH)3 (167) x2 | Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | GI.1/GII.4 (15/15) - MPL (50) | Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With a Seroresponse (Pan-Ig ELISA) | Seroresponse was defined as 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 virus-Like particle (VLP) and GII.4 VLP as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA). | Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Day 56 |
|
Unsolicited AEs 28 days after each vaccination (Day 1 to 56) and Serious Adverse Events (SAEs) throughout the trial (Up to Day 393)
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GI.1/GII.4 (15/15) - MPL (50) | Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chondropathy | Musculoskeletal and connective tissue disorders | MedDRA version 18.0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 18.0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director, Clinical Science | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| ID | Term |
|---|---|
| D022362 | Hepatitis A Vaccines |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| GI.1/GII.4 (15/50) - MPL (15) | Experimental | IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28. |
|
| GI.1/GII.4 (50/50) - MPL (15) | Experimental | Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28. |
|
| GI.1/GII.4 (15/15) | Experimental | Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28. |
|
| GI.1/GII.4 (15/50) | Experimental | Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28. |
|
| GI.1/GII.4 (50/50) | Experimental | Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28. |
|
| GI.1/GII.4 (50/150) | Experimental | Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28. |
|
| GI.1/GII.4 (15/50) - Al(OH)3 (167) | Experimental | Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28. |
|
| GI.1/GII.4 (15/50) x2 | Experimental | Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28. |
|
| GI.1/GII.4 (50/150) x2 | Experimental | Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28. |
|
| GI.1/GII.4 (15/50) - Al(OH)3 (167) x2 | Experimental | Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28. |
|
|
| Norovirus Bivalent VLP Vaccine | Biological | Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection |
|
| Days 1 through 7 |
| Oral Body Temperature Within 7 Days After Dose 2 | Oral body temperature measurement is to be performed using the thermometer provided by the site for 7 days after each vaccination. The highest body temperature observed each day will be recorded on the Diary Card also provided by the site. | Days 28 through 34 |
| Percentage of Participants With Unsolicited Adverse Events (AEs) | Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study. | Day 1 up to Day 56 |
| Percentage of Participants With Serious Adverse Events (SAEs) | A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. | Day 1 up to Day 393 |
| Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA) | The percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for GI.1 virus-like particle (VLP) as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA). D=Day | Baseline and Days 28, 56, 208 and 393 |
| Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA) | The percentage of participants with a 4-fold rise or greater from in serum anti-norovirus antibody titers for GII.4 virus-like particle (VLP) as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA). D=Day | Baseline and Days 28, 56, 208 and 393 |
| Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Geometric mean titer (GMT) of anti-norovirus GI.1 VLP antibody titers as measured by pan-Ig ELISA. D=Day | Day 1 (Baseline) and Days 28, 56, 208 and 393 |
| Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Geometric mean titer (GMT) of anti-norovirus GII.4 VLP antibody titers as measured by pan-Ig ELISA. D=Day | Day 1 (Baseline) and Days 28, 56, 208 and 393 |
| Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by pan-Ig ELISA. D=Day | Days 28, 56, 208 and 393 |
| Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by pan-Ig ELISA. D=Day | Days 28, 56, 208 and 393 |
| Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA) | Percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 VLP and GII.4 VLP as measured by immunoglobulin A (IgA) enzyme-linked immunosorbent assay (ELISA) for all arms on day 28 and day 56 and for selected arms on day 208 and day 393. D=Day | Baseline and Days 28, 56, 208 and 393 |
| Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA) | The percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for GI.1 virus-like particle (VLP) as measured by immunoglobulin A (IgA) enzyme-linked immunosorbent assay (ELISA) for all arms on day 28 and day 56 and for selected arms on day 208 and day 393. D=Day | Baseline and Days 28, 56, 208 and 393 |
| Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA) | The percentage of participants with a 4-fold rise from or greater in serum anti-norovirus antibody titers for GII.4 virus-like particle (VLP) as measured by immunoglobulin A (IgA) enzyme-linked immunosorbent assay (ELISA) for all arms on day 28 and day 56 and for selected arms on day 208 and day 393. D=Day | Baseline and Days 28, 56, 208 and 393 |
| Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA) | Geometric mean titer (GMT) of anti-norovirus GI.1 VLP antibody titers as measured by IgA ELISA for all arms on day 28 and day 56 and for selected arms on day 208 and day 393. D=Day | Day 1 (Baseline) and Days 28, 56, 208 and 393 |
| Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA) | Geometric mean titer (GMT) of anti-norovirus GII.4 VLP antibody titers as measured by IgA ELISA for all arms on day 28 and day 56 and for selected arms on day 208 and day 393. D=Day | Day 1 (Baseline) and Days 28, 56, 208 and 393 |
| Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA) | Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by IgA ELISA for all arms on day 28 and day 56 and for selected arms on day 208 and day 393. D=Day | Days 28, 56, 208 and 393 |
| Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA) | Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by IgA ELISA for all arms on day 28 and day 56 and for selected arms on day 208 and day 393. D=Day | Days 28, 56, 208 and 393 |
| Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA) | Percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 VLP and GII.4 VLP as measured by histoblood group antigen (HBGA) binding assay. D=Day | Baseline and Days 28, 56, 208 and 393 |
| Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA) | The percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for GI.1 virus-like particle (VLP) as measured by HBGA binding assay. D=Day | Baseline and Days 28, 56, 208 and 393 |
| Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA) | The percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for GII.4 virus-like particle (VLP) as measured by HBGA binding assay. D=Day | Baseline and Days 28, 56, 208 and 393 |
| Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA) | Blocking titers 50 (BT50) of anti-norovirus GI.1 VLP antibody titers as measured by HBGA binding assay. D=Day | Baseline (Day 1) and Days 28, 56, 208 and 393 |
| Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA) | Blocking titers 50 (BT50) of anti-norovirus GII.4 VLP antibody titers as measured by HBGA binding assay. D=Day | Day 1 (Baseline) and Days 28, 56, 208 and 393 |
| Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA) | Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by HBGA binding assay. D=Day | Days 28, 56, 208 and 393 |
| Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA) | Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by the HBGA binding assay. D=Day | Days 28, 56, 208 and 393 |
| GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA) | GMFR of anti-norovirus GII.4 Cincinnati antibody titers as measured by HBGA binding assay. D=Day | Days 28, 56, 208 and 393 |
| GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA) | GMFR of anti-norovirus GII.4 Sydney antibody titers as measured by HBGA binding assay. D=Day | Days 28, 56, 208 and 393 |
| GMFR of Antibody Titers of Strains Not Represented in the Investigational Vaccine: Cross-Protection Assays | GMFR of anti-norovirus Cross-Protection Assays: GII.2 EC50, GI.3 EC50 and GII.4.2012 EC50 antibody titers as measured by HBGA binding assay. Data was collected for selected arms only. D=Day | Day 56 |
| Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA) | Blocking titers 50 (BT50) of anti-norovirus GII.4 Cincinnati antibody titers as measured by HBGA binding assay. D=Day | Day 1 (Baseline) and Days 28, 56, 208 and 393 |
| Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA) | Blocking Titers 50 (BT50) of anti-norovirus GII.4 Sydney antibody titers as measured by HBGA binding assay. D=Day | Day 1 (Baseline) and Days 28, 56, 208 and 393 |
| Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GII.2 EC50 (HBGA) | Blocking titers 50 (BT50) of anti-norovirus Cross-Protection Assay: GII.2 EC50 antibody titers as measured by HBGA binding assay. Data was collected for selected arms only. D=Day | Day 1 (Baseline) and Day 56 |
| Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GI.3 EC50 (HBGA) | Blocking titers 50 (BT50) of anti-norovirus Cross-Protection Assay: GI.3 EC50 antibody titers as measured by HBGA binding assay. Data was collected for selected arms only. D=Day | Day 1 (Baseline) and Day 56 |
| Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GII.4.2012 EC50 (HBGA) | Blocking titers 50 (BT50) of anti-norovirus Cross-Protection Assay: GII.4.2012 EC50 antibody titers as measured by HBGA binding assay. Data was collected for selected arms only. D=Day | Day 1 (Baseline) and Day 56 |
| Percentage of Participants With Significant New Medical Conditions | Significant new medical conditions will be evaluated by the investigator for the co-existence of any of the following conditions: Adverse events of special interest (AESIs) are predefined events for potential immune mediated disorders. All AESIs are medically evaluated to assess if they might indicate an immune-mediated disorder. Immune mediated events (IMEs) are AEs that represent a new diagnosis of a chronic medical condition that was not present or suspected prior to enrollment. | Day 1 up to Day 56 |
| Percentage of Participants With Any Adverse Event (AE) Leading to Withdrawal From the Study | Withdrawal due to an AE will occur if the participant experiences an AE that requires early termination because continued participation imposes an unacceptable risk to the participant's health or the participants is unwilling to continue because of the AE. | Day 1 up to Day 56 |
| Ghent |
| 9000 |
| Belgium |
| Withdrawal by Subject |
|
| GI.1/GII.4 (15/50) - MPL (50) |
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28. |
| BG002 | GI.1/GII.4 (50/50) - MPL (50) | Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28. |
| BG003 | GI.1/GII.4 (15/15) - MPL (15) | Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28. |
| BG004 | GI.1/GII.4 (15/50) - MPL (15) | IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28. |
| BG005 | GI.1/GII.4 (50/50) - MPL (15) | Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28. |
| BG006 | GI.1/GII.4 (15/15) | Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28. |
| BG007 | GI.1/GII.4 (15/50) | Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28. |
| BG008 | GI.1/GII.4 (50/50) | Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28. |
| BG009 | GI.1/GII.4 (50/150) | Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28. |
| BG010 | GI.1/GII.4 (15/50) - Al(OH)3 (167) | Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28. |
| BG011 | GI.1/GII.4 (15/50) x2 | Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28. |
| BG012 | GI.1/GII.4 (50/150) x2 | Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28. |
| BG013 | GI.1/GII.4 (15/50) - Al(OH)3 (167) x2 | Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28. |
| BG014 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Median | Full Range | cm |
|
| Weight | Median | Full Range | kg |
|
| Body Mass Index (BMI) | Median | Full Range | kg/m^2 |
|
| OG001 |
| GI.1/GII.4 (15/50) - MPL (50) |
Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28. |
| OG002 | GI.1/GII.4 (50/50) - MPL (50) | Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28. |
| OG003 | GI.1/GII.4 (15/15) - MPL (15) | Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28. |
| OG004 | GI.1/GII.4 (15/50) - MPL (15) | IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28. |
| OG005 | GI.1/GII.4 (50/50) - MPL (15) | Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28. |
| OG006 | GI.1/GII.4 (15/15) | Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28. |
| OG007 | GI.1/GII.4 (15/50) | Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28. |
| OG008 | GI.1/GII.4 (50/50) | Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28. |
| OG009 | GI.1/GII.4 (50/150) | Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28. |
| OG010 | GI.1/GII.4 (15/50) - Al(OH)3 (167) | Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28. |
| OG011 | GI.1/GII.4 (15/50) x2 | Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28. |
| OG012 | GI.1/GII.4 (50/150) x2 | Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28. |
| OG013 | GI.1/GII.4 (15/50) - Al(OH)3 (167) x2 | Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28. |
|
|
| Primary | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1 | Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occurred within 7 days after each vaccination. | Safety population included all participants who received at least one dose of trial vaccine. | Posted | Number | percentage of participants | Days 1 through 7 |
|
|
|
| Primary | Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2 | Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occurred within 7 days after each vaccination. | Safety population included all participants who received at least one dose of trial vaccine. | Posted | Number | percentage of participants | Days 28 through 34 |
|
|
|
| Primary | Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1 | Solicited systemic AEs are defined as: headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea that occurred within 7 days after each vaccination. | Safety population included all participants who received at least one dose of trial vaccine. | Posted | Number | percentage of participants | Days 1 through 7 |
|
|
|
| Primary | Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2 | Solicited systemic AEs are defined as: headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea that occurred within 7 days after each vaccination. | Safety population included all participants who received at least one dose of trial vaccine. | Posted | Number | percentage of participants | Days 28 through 34 |
|
|
|
| Primary | Oral Body Temperature Within 7 Days After Dose 1 | Oral body temperature measurement is to be performed using the thermometer provided by the site for 7 days after each vaccination. The highest body temperature observed each day will be recorded on the Diary Card also provided by the site. | Safety population included all participants who received at least one dose of trial vaccine. | Posted | Mean | Standard Deviation | degrees Celsius | Days 1 through 7 |
|
|
|
| Primary | Oral Body Temperature Within 7 Days After Dose 2 | Oral body temperature measurement is to be performed using the thermometer provided by the site for 7 days after each vaccination. The highest body temperature observed each day will be recorded on the Diary Card also provided by the site. | Safety population included all participants who received at least one dose of trial vaccine. | Posted | Mean | Standard Deviation | degrees Celsius | Days 28 through 34 |
|
|
|
| Primary | Percentage of Participants With Unsolicited Adverse Events (AEs) | Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study. | Safety population included all participants who received at least one dose of trial vaccine. | Posted | Number | percentage of participants | Day 1 up to Day 56 |
|
|
|
| Primary | Percentage of Participants With Serious Adverse Events (SAEs) | A serious adverse event (SAE) is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. | Safety population included all participants who received at least one dose of trial vaccine. | Posted | Number | percentage of participants | Day 1 up to Day 393 |
|
|
|
| Secondary | Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA) | Seroresponse was defined as 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 virus-Like particle (VLP) and GII.4 VLP as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA). D=Day | Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. "n" in the category is the number of participants with data available at the given time-point. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Days 28, 208 and 393 |
|
|
|
| Secondary | Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA) | The percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for GI.1 virus-like particle (VLP) as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA). D=Day | Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. "n" in the category is the number of participants with data available at the given time-point. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Days 28, 56, 208 and 393 |
|
|
|
| Secondary | Percentage of Participants With a 4-Fold Rise or Greater in GII.4 VLP Antibody Titer (Pan-Ig ELISA) | The percentage of participants with a 4-fold rise or greater from in serum anti-norovirus antibody titers for GII.4 virus-like particle (VLP) as measured by pan immunoglobulin (Pan-Ig) enzyme-linked immunosorbent assay (ELISA). D=Day | Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. "n" in the category is the number of participants with data available at the given time-point. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Days 28, 56, 208 and 393 |
|
|
|
| Secondary | Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Geometric mean titer (GMT) of anti-norovirus GI.1 VLP antibody titers as measured by pan-Ig ELISA. D=Day | Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. "n" in the category is the number of participants with data available at the given time-point. | Posted | Geometric Mean | Standard Deviation | titer | Day 1 (Baseline) and Days 28, 56, 208 and 393 |
|
|
|
| Secondary | Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Geometric mean titer (GMT) of anti-norovirus GII.4 VLP antibody titers as measured by pan-Ig ELISA. D=Day | Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. "n" in the category is the number of participants with data available at the given time-point. | Posted | Geometric Mean | Standard Deviation | titer | Day 1 (Baseline) and Days 28, 56, 208 and 393 |
|
|
|
| Secondary | Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA) | Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by pan-Ig ELISA. D=Day | Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. "n" in the category is the number of participants with data available at the given time-point. | Posted | Geometric Mean | Standard Deviation | ratio | Days 28, 56, 208 and 393 |
|
|
|
| Secondary | Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA) | Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by pan-Ig ELISA. D=Day | Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. "n" in the category is the number of participants with data available at the given time-point. | Posted | Geometric Mean | Standard Deviation | ratio | Days 28, 56, 208 and 393 |
|
|
|
| Secondary | Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP and GII.4 VLP Antibody Titers (IgA ELISA) | Percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 VLP and GII.4 VLP as measured by immunoglobulin A (IgA) enzyme-linked immunosorbent assay (ELISA) for all arms on day 28 and day 56 and for selected arms on day 208 and day 393. D=Day | Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. "n" in the category is the number of participants with data available at the given time-point. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Days 28, 56, 208 and 393 |
|
|
|
| Secondary | Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (IgA ELISA) | The percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for GI.1 virus-like particle (VLP) as measured by immunoglobulin A (IgA) enzyme-linked immunosorbent assay (ELISA) for all arms on day 28 and day 56 and for selected arms on day 208 and day 393. D=Day | Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. "n" in the category is the number of participants with data available at the given time-point. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Days 28, 56, 208 and 393 |
|
|
|
| Secondary | Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (IgA ELISA) | The percentage of participants with a 4-fold rise from or greater in serum anti-norovirus antibody titers for GII.4 virus-like particle (VLP) as measured by immunoglobulin A (IgA) enzyme-linked immunosorbent assay (ELISA) for all arms on day 28 and day 56 and for selected arms on day 208 and day 393. D=Day | Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. "n" in the category is the number of participants with data available at the given time-point. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Days 28, 56, 208 and 393 |
|
|
|
| Secondary | Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA) | Geometric mean titer (GMT) of anti-norovirus GI.1 VLP antibody titers as measured by IgA ELISA for all arms on day 28 and day 56 and for selected arms on day 208 and day 393. D=Day | Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. "n" in the category is the number of participants with data available at the given time-point. | Posted | Geometric Mean | Standard Deviation | titer | Day 1 (Baseline) and Days 28, 56, 208 and 393 |
|
|
|
| Secondary | Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA) | Geometric mean titer (GMT) of anti-norovirus GII.4 VLP antibody titers as measured by IgA ELISA for all arms on day 28 and day 56 and for selected arms on day 208 and day 393. D=Day | Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. "n" in the category is the number of participants with data available at the given time-point. | Posted | Geometric Mean | Standard Deviation | titer | Day 1 (Baseline) and Days 28, 56, 208 and 393 |
|
|
|
| Secondary | Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA) | Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by IgA ELISA for all arms on day 28 and day 56 and for selected arms on day 208 and day 393. D=Day | Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. "n" in the category is the number of participants with data available at the given time-point. | Posted | Geometric Mean | Standard Deviation | ratio | Days 28, 56, 208 and 393 |
|
|
|
| Secondary | Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA) | Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by IgA ELISA for all arms on day 28 and day 56 and for selected arms on day 208 and day 393. D=Day | Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. "n" in the category is the number of participants with data available at the given time-point. | Posted | Geometric Mean | Standard Deviation | ratio | Days 28, 56, 208 and 393 |
|
|
|
| Secondary | Percentage of Participants With a 4-Fold Rise or Greater in Serum Antibody Titers for GI.1 VLP and GII.4 VLP(HBGA) | Percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for both GI.1 VLP and GII.4 VLP as measured by histoblood group antigen (HBGA) binding assay. D=Day | Full Analysis Set included all randomized participants who received at least one dose of trial vaccine. "n" in the category is the number of participants with data available at the given time-point. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Days 28, 56, 208 and 393 |
|
|
|
| Secondary | Percentage of Participants With a 4-Fold Rise or Greater in Serum GI.1 VLP Antibody Titers (HBGA) | The percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for GI.1 virus-like particle (VLP) as measured by HBGA binding assay. D=Day | Per-Protocol Set included all participants who received both doses of study drug and who had no major protocol violations. "n" in the category is the number of participants with data available at the given time-point. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Days 28, 56, 208 and 393 |
|
|
|
| Secondary | Percentage of Participants With a 4-Fold Rise or Greater in Serum GII.4 VLP Antibody Titers (HBGA) | The percentage of participants with a 4-fold rise or greater in serum anti-norovirus antibody titers for GII.4 virus-like particle (VLP) as measured by HBGA binding assay. D=Day | Per-Protocol Set included all participants who received both doses of study drug and who had no major protocol violations. "n" in the category is the number of participants with data available at the given time-point. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline and Days 28, 56, 208 and 393 |
|
|
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| Secondary | Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA) | Blocking titers 50 (BT50) of anti-norovirus GI.1 VLP antibody titers as measured by HBGA binding assay. D=Day | Full Analysis Set included all participants who received at least one dose of trial vaccine. "n" in the category is the number of participants with data available at the given time-point. | Posted | Geometric Mean | Standard Deviation | titer | Baseline (Day 1) and Days 28, 56, 208 and 393 |
|
|
|
| Secondary | Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA) | Blocking titers 50 (BT50) of anti-norovirus GII.4 VLP antibody titers as measured by HBGA binding assay. D=Day | Full Analysis Set included all participants who received at least one dose of trial vaccine. "n" in the category is the number of participants with data available at the given time-point. | Posted | Geometric Mean | Standard Deviation | titer | Day 1 (Baseline) and Days 28, 56, 208 and 393 |
|
|
|
| Secondary | Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA) | Geometric mean fold rise (GMFR) of anti-norovirus GI.1 VLP antibody titers as measured by HBGA binding assay. D=Day | Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. "n" in the category is the number of participants with data available at the given time-point. | Posted | Geometric Mean | Standard Deviation | titer | Days 28, 56, 208 and 393 |
|
|
|
| Secondary | Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA) | Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by the HBGA binding assay. D=Day | Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. "n" in the category is the number of participants with data available at the given time-point. | Posted | Geometric Mean | Standard Deviation | titer | Days 28, 56, 208 and 393 |
|
|
|
| Secondary | GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA) | GMFR of anti-norovirus GII.4 Cincinnati antibody titers as measured by HBGA binding assay. D=Day | Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. "n" in the category is the number of participants with data available at the given time-point. | Posted | Geometric Mean | Standard Deviation | titer | Days 28, 56, 208 and 393 |
|
|
|
| Secondary | GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA) | GMFR of anti-norovirus GII.4 Sydney antibody titers as measured by HBGA binding assay. D=Day | Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. "n" in the category is the number of participants with data available at the given time-point. | Posted | Geometric Mean | Standard Deviation | titer | Days 28, 56, 208 and 393 |
|
|
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| Secondary | GMFR of Antibody Titers of Strains Not Represented in the Investigational Vaccine: Cross-Protection Assays | GMFR of anti-norovirus Cross-Protection Assays: GII.2 EC50, GI.3 EC50 and GII.4.2012 EC50 antibody titers as measured by HBGA binding assay. Data was collected for selected arms only. D=Day | Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. Data was only collected for 2 of the arms. | Posted | Geometric Mean | Standard Deviation | titer | Day 56 |
|
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| Secondary | Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA) | Blocking titers 50 (BT50) of anti-norovirus GII.4 Cincinnati antibody titers as measured by HBGA binding assay. D=Day | Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. "n" in the category is the number of participants with data available at the given time-point. | Posted | Geometric Mean | Standard Deviation | titer | Day 1 (Baseline) and Days 28, 56, 208 and 393 |
|
|
|
| Secondary | Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA) | Blocking Titers 50 (BT50) of anti-norovirus GII.4 Sydney antibody titers as measured by HBGA binding assay. D=Day | Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. "n" in the category is the number of participants with data available at the given time-point. | Posted | Geometric Mean | Standard Deviation | titer | Day 1 (Baseline) and Days 28, 56, 208 and 393 |
|
|
|
| Secondary | Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GII.2 EC50 (HBGA) | Blocking titers 50 (BT50) of anti-norovirus Cross-Protection Assay: GII.2 EC50 antibody titers as measured by HBGA binding assay. Data was collected for selected arms only. D=Day | Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. Data was only collected for 2 of the arms. | Posted | Geometric Mean | Standard Deviation | titer | Day 1 (Baseline) and Day 56 |
|
|
|
| Secondary | Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GI.3 EC50 (HBGA) | Blocking titers 50 (BT50) of anti-norovirus Cross-Protection Assay: GI.3 EC50 antibody titers as measured by HBGA binding assay. Data was collected for selected arms only. D=Day | Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. Data was only collected for 2 of the arms. | Posted | Geometric Mean | Standard Deviation | titer | Day 1 (Baseline) and Day 56 |
|
|
|
| Secondary | Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: Cross-Protection Assay: GII.4.2012 EC50 (HBGA) | Blocking titers 50 (BT50) of anti-norovirus Cross-Protection Assay: GII.4.2012 EC50 antibody titers as measured by HBGA binding assay. Data was collected for selected arms only. D=Day | Per-Protocol Set included all participants who received both doses of trial vaccine and who had no major protocol violations. Data was only collected for 2 of the arms. | Posted | Geometric Mean | Standard Deviation | titer | Day 1 (Baseline) and Day 56 |
|
|
|
| Secondary | Percentage of Participants With Significant New Medical Conditions | Significant new medical conditions will be evaluated by the investigator for the co-existence of any of the following conditions: Adverse events of special interest (AESIs) are predefined events for potential immune mediated disorders. All AESIs are medically evaluated to assess if they might indicate an immune-mediated disorder. Immune mediated events (IMEs) are AEs that represent a new diagnosis of a chronic medical condition that was not present or suspected prior to enrollment. | Safety Analysis Set included all participants who received at least one dose of trial vaccine. | Posted | Number | percentage of participants | Day 1 up to Day 56 |
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|
|
| Secondary | Percentage of Participants With Any Adverse Event (AE) Leading to Withdrawal From the Study | Withdrawal due to an AE will occur if the participant experiences an AE that requires early termination because continued participation imposes an unacceptable risk to the participant's health or the participants is unwilling to continue because of the AE. | Safety Analysis Set included all participants who received at least one dose of trial vaccine. | Posted | Number | percentage of participants | Day 1 up to Day 56 |
|
|
|
| 2 |
| 30 |
| 10 |
| 30 |
| EG001 | GI.1/GII.4 (15/50) - MPL (50) | Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28. | 0 | 30 | 12 | 30 |
| EG002 | GI.1/GII.4 (50/50) - MPL (50) | Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28. | 5 | 30 | 7 | 30 |
| EG003 | GI.1/GII.4 (15/15) - MPL (15) | Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28. | 2 | 31 | 10 | 31 |
| EG004 | GI.1/GII.4 (15/50) - MPL (15) | IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28. | 1 | 30 | 9 | 30 |
| EG005 | GI.1/GII.4 (50/50) - MPL (15) | Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28. | 0 | 31 | 9 | 31 |
| EG006 | GI.1/GII.4 (15/15) | Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28. | 3 | 30 | 7 | 30 |
| EG007 | GI.1/GII.4 (15/50) | Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28. | 3 | 32 | 11 | 32 |
| EG008 | GI.1/GII.4 (50/50) | Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28. | 1 | 29 | 8 | 29 |
| EG009 | GI.1/GII.4 (50/150) | Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28. | 1 | 30 | 6 | 30 |
| EG010 | GI.1/GII.4 (15/50) - Al(OH)3 (167) | Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28. | 1 | 29 | 6 | 29 |
| EG011 | GI.1/GII.4 (15/50) x2 | Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28. | 2 | 28 | 9 | 28 |
| EG012 | GI.1/GII.4 (50/150) x2 | Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28. | 1 | 29 | 8 | 29 |
| EG013 | GI.1/GII.4 (15/50) - Al(OH)3 (167) x2 | Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28. | 1 | 31 | 9 | 31 |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA version 18.0 |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA version 18.0 |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 18.0 |
|
| Appendicitis | Infections and infestations | MedDRA version 18.0 |
|
| Erysipelas | Infections and infestations | MedDRA version 18.0 |
|
| Gastroenteritis bacterial | Infections and infestations | MedDRA version 18.0 |
|
| Leptospirosis | Infections and infestations | MedDRA version 18.0 |
|
| Meningitis aseptic | Infections and infestations | MedDRA version 18.0 |
|
| Pneumonia | Infections and infestations | MedDRA version 18.0 |
|
| Compression fracture | Injury, poisoning and procedural complications | MedDRA version 18.0 |
|
| Tendon injury | Injury, poisoning and procedural complications | MedDRA version 18.0 |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA version 18.0 |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA version 18.0 |
|
| Intestinal polyp | Gastrointestinal disorders | MedDRA version 18.0 |
|
| Large intestinal polyp | Gastrointestinal disorders | MedDRA version 18.0 |
|
| Biliary colic | Hepatobiliary disorders | MedDRA version 18.0 |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA version 18.0 |
|
| Goitre | Endocrine disorders | MedDRA version 18.0 |
|
| Cervix carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.0 |
|
| Rectal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 18.0 |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA version 18.0 |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 |
|
| Major depression | Psychiatric disorders | MedDRA version 18.0 |
|
| Pharyngeal abscess | Infections and infestations | MedDRA version 18.0 |
|
| Nausea | Gastrointestinal disorders | MedDRA version 18.0 |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA version 18.0 |
|
| Fatigue | General disorders | MedDRA version 18.0 |
|
| Injection site pain | General disorders | MedDRA version 18.0 |
|
| Influenza like illness | General disorders | MedDRA version 18.0 |
|
| Nasopharyngitis | Infections and infestations | MedDRA version 18.0 |
|
| Headache | Nervous system disorders | MedDRA version 18.0 |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 18.0 |
|
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.
| D045424 |
| Complex Mixtures |
| Erythema |
|
| Induration |
|
| Swelling |
|
| Erythema |
|
| Induration |
|
| Swelling |
|
| Fatigue |
|
| Myalgia |
|
| Arthralgia |
|
| Vomiting |
|
| Diarrhea |
|
| Fatigue |
|
| Myalgia |
|
| Arthralgia |
|
| Vomiting |
|
| Diarrhea |
|
| D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,28) |
|
| D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29) |
|
| D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30) |
|
| D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27) |
|
| D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28) |
|
| D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30) |
|
| D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27) |
|
| D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28) |
|
| D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31) |
|
| D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30) |
|
| D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29) |
|
| D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29) |
|
| D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31) |
|
| D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30) |
|
| D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29) |
|
| D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29) |
|
| D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30) |
|
| D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27) |
|
| D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28) |
|
| D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30) |
|
| D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27) |
|
| D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28) |
|
| D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30) |
|
| D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0) |
|
| D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0) |
|
| D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30) |
|
| D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0) |
|
| D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0) |
|
| D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30) |
|
| D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0) |
|
| D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0) |
|
| D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31) |
|
| D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30 |
|
| D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0) |
|
| D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0) |
|
| D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31) |
|
| D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30) |
|
| D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0) |
|
| D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0) |
|
| D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30) |
|
| D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0) |
|
| D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0) |
|
| D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30) |
|
| D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0) |
|
| D393 (n=0,0,0,0,30,0,0,31,0,0,0,0,0,0) |
|
| D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30) |
|
| D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,28) |
|
| D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,28) |
|
| D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30) |
|
| D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27) |
|
| D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28) |
|
| D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30) |
|
| D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27) |
|
| D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28) |
|
| D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31) |
|
| D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30) |
|
| D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29) |
|
| D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,29) |
|
| D28 (n=30,30,29,31,30,31,30,32,28,30,27,28,29,31) |
|
| D56 (n=30,29,28,31,30,31,30,32,28,30,26,28,29,30) |
|
| D208 (n=30,29,30,31,30,30,30,32,29,30,27,28,29,29) |
|
| D393 (n=29,29,30,31,30,29,29,32,29,30,27,28,29,28) |
|
| D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30) |
|
| D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27) |
|
| D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28) |
|
| D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30) |
|
| D208 (n=30,29,28,29,30,30,30,32,28,30,24,28,29,27) |
|
| D393 (n=29,28,28,29,30,29,29,32,28,30,24,28,29,28) |
|
| D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30) |
|
| D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0) |
|
| D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0) |
|
| D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30) |
|
| D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0) |
|
| D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0) |
|
| GII.4.2012 EC50 |
|
| D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30) |
|
| D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30) |
|
| D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0) |
|
| D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0) |
|
| D28 (n=30,29,27,29,30,31,30,32,27,30,24,28,29,30) |
|
| D56 (n=30,29,28,29,30,31,30,32,28,30,24,28,29,30) |
|
| D208 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0) |
|
| D393 (n=0,0,0,0,30,0,0,32,0,0,0,0,0,0) |
|
| IMEs |
|