Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent VLP Vaccine
Condition: Healthy Volunteers; Norovirus, Prevention
Intervention: Hepatitis A Vaccine; Norovirus Bivalent VLP Vaccine
Intervention description: Hepatitis A Vaccine IM injection; Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 420.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Norovirus, vaccination

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.
    

Eligibility 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.