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Trial record 1 of 1 for:    NCT02038907
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Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent VLP Vaccine (NOR-107)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02038907
First Posted: January 17, 2014
Last Update Posted: August 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Takeda
  Purpose
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.

Condition Intervention Phase
Healthy Volunteers Norovirus, Prevention Biological: Hepatitis A Vaccine Biological: Norovirus Bivalent VLP Vaccine Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

    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


  • 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 ]

    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


  • 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 ]

    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


  • 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 anti-norovirus GI.1 VLP antibody titers as measured by pan-Ig ELISA.

    D=Day


  • 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 titer (GMT) of anti-norovirus GII.4 VLP antibody titers as measured by pan-Ig ELISA.

    D=Day


  • 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 anti-norovirus GI.1 VLP antibody titers as measured by pan-Ig ELISA.

    D=Day


  • Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (Pan-Ig ELISA) [ Time Frame: Days 28, 56, 208 and 393 ]

    Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by pan-Ig ELISA.

    D=Day


  • 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 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


  • 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 ]

    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


  • 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 ]

    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


  • 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 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


  • 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 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


  • 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 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


  • Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (IgA ELISA) [ Time Frame: Days 28, 56, 208 and 393 ]

    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


  • 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 anti-norovirus antibody titers for both GI.1 VLP and GII.4 VLP as measured by histoblood group antigen (HBGA) binding assay.

    D=Day


  • 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 ]

    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


  • 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 ]

    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


  • 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 anti-norovirus GI.1 VLP antibody titers as measured by HBGA binding assay.

    D=Day


  • Blocking Titers 50 (BT50) of GII.4 VLP Antibody Titers (HBGA) [ Time Frame: Day 1 (Baseline) and Days 28, 56, 208 and 393 ]

    Blocking titers 50 (BT50) of anti-norovirus GII.4 VLP antibody titers as measured by HBGA binding assay.

    D=Day


  • 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 anti-norovirus GI.1 VLP antibody titers as measured by HBGA binding assay.

    D=Day


  • Geometric Mean Fold Rise (GMFR) of GII.4 VLP Antibody Titers (HBGA) [ Time Frame: Days 28, 56, 208 and 393 ]

    Geometric mean fold rise (GMFR) of anti-norovirus GII.4 VLP antibody titers as measured by the HBGA binding assay.

    D=Day


  • 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 anti-norovirus GII.4 Cincinnati antibody titers as measured by HBGA binding assay.

    D=Day


  • 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 anti-norovirus GII.4 Sydney antibody titers as measured by HBGA binding assay.

    D=Day


  • GMFR of Antibody Titers of Strains Not Represented in the Investigational Vaccine: Cross-Protection Assays [ Time Frame: Day 56 ]

    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


  • 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 anti-norovirus GII.4 Cincinnati antibody titers as measured by HBGA binding assay.

    D=Day


  • 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 anti-norovirus GII.4 Sydney antibody titers as measured by HBGA binding assay.

    D=Day


  • 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 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


  • 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 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


  • 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 ]

    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


  • Percentage of Participants With Significant New Medical Conditions [ Time Frame: Day 1 up to Day 56 ]

    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.


  • Percentage of Participants With Any Adverse Event (AE) Leading to Withdrawal From the Study [ Time Frame: Day 1 up to Day 56 ]
    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.


Enrollment: 420
Actual Study Start Date: March 28, 2014
Study Completion Date: June 19, 2015
Primary Completion Date: June 19, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Biological: Hepatitis A Vaccine
Hepatitis A Vaccine IM injection
Other Name: Havrix
Biological: Norovirus Bivalent VLP Vaccine
Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection
Experimental: 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.
Biological: Hepatitis A Vaccine
Hepatitis A Vaccine IM injection
Other Name: Havrix
Biological: Norovirus Bivalent VLP Vaccine
Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection
Experimental: 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.
Biological: Hepatitis A Vaccine
Hepatitis A Vaccine IM injection
Other Name: Havrix
Biological: Norovirus Bivalent VLP Vaccine
Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection
Experimental: 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.
Biological: Hepatitis A Vaccine
Hepatitis A Vaccine IM injection
Other Name: Havrix
Biological: Norovirus Bivalent VLP Vaccine
Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection
Experimental: 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.
Biological: Hepatitis A Vaccine
Hepatitis A Vaccine IM injection
Other Name: Havrix
Biological: Norovirus Bivalent VLP Vaccine
Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection
Experimental: 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.
Biological: Hepatitis A Vaccine
Hepatitis A Vaccine IM injection
Other Name: Havrix
Biological: Norovirus Bivalent VLP Vaccine
Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection
Experimental: 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.
Biological: Hepatitis A Vaccine
Hepatitis A Vaccine IM injection
Other Name: Havrix
Biological: Norovirus Bivalent VLP Vaccine
Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection
Experimental: 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.
Biological: Hepatitis A Vaccine
Hepatitis A Vaccine IM injection
Other Name: Havrix
Biological: Norovirus Bivalent VLP Vaccine
Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection
Experimental: 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.
Biological: Hepatitis A Vaccine
Hepatitis A Vaccine IM injection
Other Name: Havrix
Biological: Norovirus Bivalent VLP Vaccine
Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection
Experimental: 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.
Biological: Hepatitis A Vaccine
Hepatitis A Vaccine IM injection
Other Name: Havrix
Biological: Norovirus Bivalent VLP Vaccine
Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection
Experimental: 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.
Biological: Hepatitis A Vaccine
Hepatitis A Vaccine IM injection
Other Name: Havrix
Biological: Norovirus Bivalent VLP Vaccine
Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection
Experimental: 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.
Biological: Norovirus Bivalent VLP Vaccine
Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection
Experimental: 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.
Biological: Norovirus Bivalent VLP Vaccine
Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection
Experimental: 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.
Biological: Norovirus Bivalent VLP Vaccine
Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male and female participants between 18 and 64 years of age at the time of enrollment.
  2. 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.
  3. 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.
  4. Can comply with trial procedures and are available for the duration of the trial.

Exclusion Criteria:

  1. Has received any vaccines containing Hepatitis A vaccine within the past 5 years.
  2. Has contraindications, warnings, and/or precautions to vaccination with Havrix as specified within the Summary of Product Characteristics.
  3. 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.
  4. Has received antipyretic/analgesic medications within 24 hours prior to the intended vaccine administration.
  5. Known hypersensitivity or allergy to investigational vaccine (including excipients of the investigational vaccine).
  6. Has behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the participant's ability to participate in the trial.
  7. Has a history of any progressive or severe neurologic disorder, seizure disorder, or Guillain-Barré syndrome.
  8. 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.
  9. Known or inspected impairment/alteration of immune function, including the following:

    1. 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).
    2. 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.
    3. Receipt of immunostimulants within 60 days prior to Day 1.
    4. 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.
    5. Receipt of immunosuppressive therapy within 6 months prior to Day 1.
    6. Human immunodeficiency virus (HIV) infection or HIV-related disease.
    7. Heritable immunodeficiency.
  10. Abnormalities of splenic or thymic function.
  11. Has a known bleeding diathesis or any condition that may be associated with a prolonged bleeding time.
  12. Has any serious chronic or progressive disease according to judgment of the investigator (eg, neoplasm, insulin dependent diabetes, cardiac, renal, or hepatic disease).
  13. Has a body mass index (BMI) greater than or equal to 35 kg/m^2 (=weight in kg/[height in meters * height in meters]).
  14. 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.
  15. 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.
  16. Is first degree relatives of individuals involved in trial conduct.
  17. Has history of substance or alcohol abuse within the past 2 years.
  18. 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.
  19. 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.
  20. Female participants who plan to donate ova from Day 1 through 6 months after the last dose of investigational vaccine.
  21. Female participants with any positive pregnancy test.
  22. Female participants who are pregnant or breastfeeding.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02038907


Locations
Belgium
Universiteit Antwerpen
Edegem, Belgium, 2650
Universitair Ziekenhuis Gent
Gent, Belgium, 9000
Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Director Clinical Science Takeda
  More Information

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02038907     History of Changes
Other Study ID Numbers: NOR-107
2013-001419-64 ( EudraCT Number )
U1111-1147-3239 ( Other Identifier: WHO )
First Submitted: January 15, 2014
First Posted: January 17, 2014
Results First Submitted: June 18, 2016
Results First Posted: August 1, 2016
Last Update Posted: August 8, 2017
Last Verified: August 2017

Keywords provided by Takeda:
Norovirus, vaccination

Additional relevant MeSH terms:
Vaccines
Aluminum Hydroxide
Monophosphoryl lipid A
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents