Efficacy and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-like Particle Vaccine in Adults
Condition: Healthy Volunteers
Intervention: NoV Placebo-matching Saline; NoV GI.1/GII.4 Bivalent VLP Vaccine
Intervention description: NoV placebo-matching saline (0.9% sodium chloride).; NoV bivalent VLP vaccine, adjuvanted with 500 µg aluminum as Al(OH)3.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 4748.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug therapy

Summary:

      The purpose of this study is to evaluate the efficacy of the Norovirus (NoV) GI.1/GII.4
      bivalent virus-like particle vaccine against moderate or severe acute gastroenteritis (AGE)
      due to genotype-specific (GI.1 and GII.4) NoV strains.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participant 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.

          2. Male or female participants, 18 to 49 years of age.

          3. Is in good health at the time of entry into the trial as determined by medical history
             and the clinical judgment of the investigator.

          4. Can comply with trial procedures and are available for the duration of follow-up.

        Exclusion Criteria:

          1. Pregnancy.

          2. Has known hypersensitivity to any of the Norovirus (NoV) GI.1/GII.4 bivalent
             virus-like particle (VLP) vaccine components (including excipients).

          3. Has known hypersensitivity or allergy to any of the licensed required concomitant
             vaccine components to be administered (including excipients of these vaccines).

          4. Has any condition or circumstance that the investigator determines would interfere
             with trial evaluation or interpretation.

          5. Has known or suspected impairment or alteration of immune function.

          6. Has a history of acute gastroenteritis (AGE) within 14 days of enrollment.

          7. Has a history of body temperature of 38.0°C (100.4°F) or higher within 3 days of
             intended trial vaccination.

          8. Has received blood, blood products, and/or plasma derivatives or any parenteral
             immunoglobulin antibody preparation in the past 3 months.

          9. Immunosuppressive therapy within 3 months or systemic (e.g., oral or parenteral)
             corticosteroid treatment within 60 days prior to investigational trial dose
             administration.

         10. Is participating in any clinical trial with another investigational product 30 days
             prior to the first trial visit or intending to participate in another clinical trial
             at any time during the conduct of this trial.

         11. Participants who are first-degree relatives of individuals involved in the conduct of
             the trial.

         12. Has any history of progressive or severe neurologic disorder, seizure disorder or
             neuro-inflammatory disease (e.g. Guillain-Barré syndrome).

         13. Has history or any illness that, in the opinion of the investigator, might interfere
             with the results of the trial or pose additional risk to the participants due to
             participation in the trial.

         14. Has received any other vaccines within 14 days (for inactivated vaccines) or 28 days
             (for live vaccines) prior to enrollment in this trial with the exception of routine
             immunizations as per Military Procedures.

         15. 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:

               1. Of childbearing potential is defined as status post onset of menarche and not
                  meeting any of the following conditions: menopausal for at least 2 years, status
                  after bilateral tubal ligation for at least 1 year, status after bilateral
                  oophorectomy, or status after hysterectomy.

               2. Acceptable birth control methods are defined as one or more of the following:

                    -  Hormonal contraceptive (such as oral, injection, transdermal patch, implant,
                       cervical ring).

                    -  Barrier (condom with spermicide or diaphragm with spermicide) each and every
                       time during intercourse.

                    -  Intrauterine device (IUD).

                    -  Monogamous relationship with vasectomized partner. Partner must have been
                       vasectomized for at least six months prior to the participants' trial entry.

         16. If female of childbearing potential and sexually active, refusal to use an "acceptable
             contraceptive method" from Day 1 through 6 months after the last dose of trial
             vaccine. In addition, they must be advised not to donate ova during this period.

         17. Has any positive or indeterminate pregnancy test.