Healthy VolunteersPhase 2NOR-107NCT02038907
Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent VLP Vaccine
A Phase 2 study testing Hepatitis A Vaccine and Norovirus Bivalent VLP Vaccine in people with Healthy Volunteers and Norovirus, Prevention, run by Takeda at 2 sites in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Norovirus, Prevention
- What is being tested?
- Hepatitis A Vaccine and Norovirus Bivalent VLP Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 2 sitesBelgium
- Study dates
- 28 Mar 2014to 19 Jun 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female participants between 18 and 64 years of age at the time of enrollment.
- In good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs), and clinical judgment of the investigator.
- The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements.
- Can comply with trial procedures and are available for the duration of the trial.
Who cannot join
- 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.
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- 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:
- Chronic use of oral steroids (Equivalent to 20 mg/day prednisone for ≥12 weeks/≥2 mg/kg body weight/day for ≥2 weeks) within 60 days prior to Day 1 (use of inhaled, intranasal, or topical corticosteroids is allowed).
- Receipt of parenteral steroids (equivalent to 20 mg/day prednisone ≥12 weeks/≥2 mg/kg body weight/day for ≥2 weeks) within 60 days prior to Day 1.
- Receipt of immunostimulants within 60 days prior to Day 1.
- Receipt of parenteral, epidural, or intra-articular immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to Day 1 or planned during the full length of the trial.
- Receipt of immunosuppressive therapy within 6 months prior to Day 1.
- Human immunodeficiency virus (HIV) infection or HIV-related disease.
- Heritable immunodeficiency.
- 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.
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Universiteit Antwerpen
Edegem, 2650
Universitair Ziekenhuis Gent
Ghent, 9000
About this study
Official title: A Phase II, Randomized, Controlled, Double-Blind, Dosage and Adjuvant Justification, Safety and Immunogenicity Trial of Intramuscular Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine Adjuvanted With or Without Monophosphoryl Lipid A and Aluminum Hydroxide in Adults
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.
Read the detailed description
The vaccine being tested in this study is called norovirus GI.1/GII.4 bivalent virus-like particle (VLP) vaccine adjuvanted with aluminum hydroxide 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.
- Conditions
- Healthy Volunteers, Norovirus, Prevention
- Being tested
- Hepatitis A Vaccine, Norovirus Bivalent VLP Vaccine
- Keywords
- Norovirus, vaccination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatitis A VaccineBiological
Also called Havrix
Hepatitis A Vaccine IM injection
Norovirus Bivalent VLP VaccineBiological
Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Hepatitis A Vaccine; Biological: Norovirus Bivalent VLP Vaccine |
| 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. Receives: Biological: Hepatitis A Vaccine; Biological: Norovirus Bivalent VLP Vaccine |
| 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. Receives: Biological: Hepatitis A Vaccine; Biological: Norovirus Bivalent VLP Vaccine |
| 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. Receives: Biological: Hepatitis A Vaccine; Biological: Norovirus Bivalent VLP Vaccine |
| 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. Receives: Biological: Hepatitis A Vaccine; Biological: Norovirus Bivalent VLP Vaccine |
| 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. Receives: Biological: Hepatitis A Vaccine; Biological: Norovirus Bivalent VLP Vaccine |
| 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. Receives: Biological: Hepatitis A Vaccine; Biological: Norovirus Bivalent VLP Vaccine |
| 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. Receives: Biological: Hepatitis A Vaccine; Biological: Norovirus Bivalent VLP Vaccine |
| 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. Receives: Biological: Hepatitis A Vaccine; Biological: Norovirus Bivalent VLP Vaccine |
| 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. Receives: Biological: Hepatitis A Vaccine; Biological: Norovirus Bivalent VLP Vaccine |
| 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. Receives: Biological: Hepatitis A Vaccine; Biological: Norovirus Bivalent VLP Vaccine |
| 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. Receives: Biological: Norovirus Bivalent VLP Vaccine |
| 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. Receives: Biological: Norovirus Bivalent VLP Vaccine |
| 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. Receives: Biological: Norovirus Bivalent VLP Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1 up to Day 393
Secondary outcomes (31)
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
Measured: Baseline and Days 28, 208 and 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Day 1 up to Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2014 (estimated)
- Study start28 Mar 2014
- Primary completion19 Jun 2015
- Study completion19 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02038907
- Sponsor's protocol ID
- NOR-107
- Other IDs
- 2013-001419-64, U1111-1147-3239
- Acronym
- NOR-107
- Status last verified
- Aug 2017
- First submitted
- 15 Jan 2014
- Last updated
- 8 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 29140444
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Controlled, Double-Blind, Dosage and Adjuvant Justification, Safety and Immunogenicity Trial of Intramuscular Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine Adjuvanted With or Without Monophosphoryl Lipid A and Aluminum Hydroxide in Adults
- ClinicalTrials.gov ID
- NCT02038907
- Acronym / sponsor ID
- NOR-107 / NOR-107
- Conditions
- Healthy Volunteers, Norovirus, Prevention
- Keywords
- Norovirus, vaccination
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 28 Mar 2014 (actual)
- Primary completion
- 19 Jun 2015 (actual)
- Study completion
- 19 Jun 2015 (actual)
- First posted
- 17 Jan 2014 (estimated)
- Results
- Posted 1 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The vaccine being tested in this study is called norovirus GI.1/GII.4 bivalent virus-like particle (VLP) vaccine adjuvanted with aluminum hydroxide 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| GI.1/GII.4 (15/15) - MPL (50) | Experimental | Biological: Hepatitis A Vaccine, Biological: Norovirus Bivalent VLP VaccineHepatitis 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 | Biological: Hepatitis A Vaccine, Biological: Norovirus Bivalent VLP VaccineHepatitis 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 | Biological: Hepatitis A Vaccine, Biological: Norovirus Bivalent VLP VaccineHepatitis 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 | Biological: Hepatitis A Vaccine, Biological: Norovirus Bivalent VLP VaccineHepatitis 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. |
| GI.1/GII.4 (15/50) - MPL (15) | Experimental | Biological: Hepatitis A Vaccine, Biological: Norovirus Bivalent VLP VaccineIM 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 | Biological: Hepatitis A Vaccine, Biological: Norovirus Bivalent VLP VaccineHepatitis 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 | Biological: Hepatitis A Vaccine, Biological: Norovirus Bivalent VLP VaccineHepatitis 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 | Biological: Hepatitis A Vaccine, Biological: Norovirus Bivalent VLP VaccineHepatitis 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 | Biological: Hepatitis A Vaccine, Biological: Norovirus Bivalent VLP VaccineHepatitis 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 | Biological: Hepatitis A Vaccine, Biological: Norovirus Bivalent VLP VaccineHepatitis 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 | Biological: Hepatitis A Vaccine, Biological: Norovirus Bivalent VLP VaccineHepatitis 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 | Biological: Norovirus Bivalent VLP VaccineNorovirus 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 | Biological: Norovirus Bivalent VLP VaccineNorovirus 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 | Biological: Norovirus Bivalent VLP VaccineNorovirus 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male and female participants between 18 and 64 years of age at the time of enrollment.
- In good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs), and clinical judgment of the investigator.
- The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements.
- Can comply with trial procedures and are available for the duration of the trial.
Key exclusion criteria (29 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hepatitis A VaccineAlso: HavrixHepatitis A Vaccine IM injection | Biological | GI.1/GII.4 (15/15), GI.1/GII.4 (15/15) - MPL (15), GI.1/GII.4 (15/15) - MPL (50), GI.1/GII.4 (15/50), GI.1/GII.4 (15/50) - Al(OH)3 (167), GI.1/GII.4 (15/50) - MPL (15), GI.1/GII.4 (15/50) - MPL (50), GI.1/GII.4 (50/150), GI.1/GII.4 (50/50), GI.1/GII.4 (50/50) - MPL (15), GI.1/GII.4 (50/50) - MPL (50) |
| Norovirus Bivalent VLP VaccineNorovirus GI.1/GII.4 bivalent VLP vaccine IM injection | Biological | GI.1/GII.4 (15/15), GI.1/GII.4 (15/15) - MPL (15), GI.1/GII.4 (15/15) - MPL (50), GI.1/GII.4 (15/50), GI.1/GII.4 (15/50) - Al(OH)3 (167), GI.1/GII.4 (15/50) - Al(OH)3 (167) x2, GI.1/GII.4 (15/50) - MPL (15), GI.1/GII.4 (15/50) - MPL (50), GI.1/GII.4 (15/50) x2, GI.1/GII.4 (50/150), GI.1/GII.4 (50/150) x2, GI.1/GII.4 (50/50), GI.1/GII.4 (50/50) - MPL (15), GI.1/GII.4 (50/50) - MPL (50) |
Primary outcome
Percentage of Participants With a Seroresponse (Pan-Ig ELISA)
Time frame: Baseline and Day 56
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).
Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 1
Time frame: Days 1 through 7
Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occurred within 7 days after each vaccination.
Percentage of Participants With Solicited Local Adverse Events (AEs) at Injection Site After Dose 2
Time frame: Days 28 through 34
Solicited local AEs at injection site are defined as: pain, erythema, induration, and swelling that occurred within 7 days after each vaccination.
Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 1
Time frame: Days 1 through 7
Solicited systemic AEs are defined as: headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea that occurred within 7 days after each vaccination.
Percentage of Participants With Solicited Systemic Adverse Events (AEs) After Dose 2
Time frame: Days 28 through 34
Solicited systemic AEs are defined as: headache, fatigue, myalgia, arthralgia, vomiting, and diarrhea that occurred within 7 days after each vaccination.
Oral Body Temperature Within 7 Days After Dose 1
Time frame: Days 1 through 7
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.
Oral Body Temperature Within 7 Days After Dose 2
Time frame: Days 28 through 34
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.
Percentage of Participants With Unsolicited Adverse Events (AEs)
Time frame: Day 1 up to Day 56
Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study.
Percentage of Participants With Serious Adverse Events (SAEs)
Time frame: Day 1 up to Day 393
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.
31 secondary outcomes
Percentage of Participants With a Seroresponse on Day 28, Day 208 and Day 393 (Pan-Ig ELISA)
Time frame: Baseline and Days 28, 208 and 393
Percentage of Participants With a 4-Fold Rise or Greater in GI.1 VLP Antibody Titer (Pan-Ig ELISA)
Time frame: 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)
Time frame: Baseline and Days 28, 56, 208 and 393
Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)
Time frame: Day 1 (Baseline) and Days 28, 56, 208 and 393
Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)
Time frame: Day 1 (Baseline) and Days 28, 56, 208 and 393
Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (Pan-Ig ELISA)
Time frame: Days 28, 56, 208 and 393
Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline and Days 28, 56, 208 and 393
Geometric Mean Titer (GMT) of GI.1 VLP Antibody Titers (IgA ELISA)
Time frame: Day 1 (Baseline) and Days 28, 56, 208 and 393
Geometric Mean Titer (GMT) of GII.4 VLP Antibody Titers (IgA ELISA)
Time frame: Day 1 (Baseline) and Days 28, 56, 208 and 393
Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (IgA ELISA)
Time frame: Days 28, 56, 208 and 393
Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline and Days 28, 56, 208 and 393
Blocking Titers 50 (BT50) of Anti-Norovirus GI.1 VLP Antibody Titers (HBGA)
Time frame: Baseline (Day 1) and Days 28, 56, 208 and 393
Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA)
Time frame: Day 1 (Baseline) and Days 28, 56, 208 and 393
Geometric Mean Fold Rise (GMFR) of GI.1 VLP Antibody Titers (HBGA)
Time frame: Days 28, 56, 208 and 393
Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA)
Time frame: Days 28, 56, 208 and 393
GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)
Time frame: Days 28, 56, 208 and 393
GMFR of Antibody Titers of a Strain Not Represented in the Investigational Vaccine: GII.4 Sydney (HBGA)
Time frame: Days 28, 56, 208 and 393
GMFR of Antibody Titers of Strains Not Represented in the Investigational Vaccine: Cross-Protection Assays
Time frame: Day 56
Blocking Titers 50 (BT50) of a Strain Not Represented in the Investigational Vaccine: GII.4 Cincinnati (HBGA)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Day 1 (Baseline) and Day 56
Percentage of Participants With Significant New Medical Conditions
Time frame: Day 1 up to Day 56
Percentage of Participants With Any Adverse Event (AE) Leading to Withdrawal From the Study
Time frame: Day 1 up to Day 56
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29140444Leroux-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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director Clinical Science study director
Takeda
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hepatitis A Vaccine and Norovirus Bivalent VLP Vaccine in people with Healthy Volunteers and Norovirus, Prevention, run by Takeda at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With a Seroresponse (Pan-Ig ELISA) (time frame: Baseline and Day 56). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02038907, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2017.