Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle (VLP) Vaccine in Children
Condition: Norovirus
Intervention: GI.1/GII.4 (15/15); GI.1/GII.4 (15/50); GI.1/GII.4 (50/50); GI.1/GII.4 (50/150); Placebo
Intervention description: Norovirus GI.1/GII.4 (15 μg/15 μg) bivalent VLP vaccine combined with 500 μg aluminum hydroxide for IM injection; Norovirus GI.1/GII.4 (15 μg/50 μg) bivalent VLP vaccine combined with 500 μg aluminum hydroxide for IM injection; Norovirus GI.1/GII.4 (50 μg/50 μg) bivalent VLP vaccine combined with 500 μg aluminum hydroxide for IM injection; Norovirus GI.1/GII.4 (50 μg/150 μg) bivalent VLP vaccine combined with 500 μg aluminum hydroxide for IM injection; Placebo saline solution
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 840.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 8 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug therapy

Summary:

      The purpose of this study is to select the optimal formulation of the norovirus vaccine from
      different concentrations of virus-like particles (VLP) combined with aluminum hydroxide for
      further development in children.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female participants aged between 6 weeks and less than 9 years at the time of
             enrollment.

          2. Are 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. Participants legally authorized representative (LAR) signs and dates a written,
             informed consent form (ICF) 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. An assent will also be obtained according
             to age-appropriate country-specific regulations.

          4. Participants who can comply with trial procedures and are available for the duration
             of the trial.

        Exclusion Criteria:

          1. Participants with a clinically significant active infection (as assessed by the
             investigator) or body temperature 38.0°C (100.4°F) or higher within 3 days of the
             intended date of vaccination.

          2. Have received antipyretic/analgesic medications within 24 hours prior to the intended
             vaccine administration.

          3. Known hypersensitivity or allergy to investigational vaccine (including excipients of
             the investigational vaccines).

          4. Participants with behavioral or cognitive impairment or psychiatric disease that, in
             the opinion of the investigator, may interfere with the ability to participate in the
             trial.

          5. Has a history of any progressive or severe neurologic disorder, seizure disorder, or
             neuroinflammatory disease (eg, Guillain-Barré syndrome).

          6. Known or suspected impairment/alteration of immune function, including the following:

               1. Children <18 months of age with history of repeated episodes of acute otitis
                  media (AOM) in the first 6 months of life (AOM defined as a bulging tympanic
                  membrane) and not to be confused with otitis media with effusion (OME).

               2. 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).

               3. 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.

               4. Receipt of immunostimulants within 60 days prior to Day 1.

               5. 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.

               6. Receipt of immunosuppressive therapy within 6 months prior to Day 1.

               7. Human immunodeficiency virus (HIV) infection or HIV-related disease.

               8. Chronic Hepatitis B or C infection.

               9. Heritable immunodeficiency.

          7. Abnormalities of splenic or thymic function.

          8. Has a known bleeding diathesis or any condition that may be associated with a
             prolonged bleeding time.

          9. Has any serious chronic or progressive disease according to judgment of the
             investigator (e.g., neoplasm, insulin dependent diabetes, cardiac, renal, or hepatic
             disease).

         10. 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.

         11. Has received any other vaccines within 14 days (for inactivated vaccines) or 28 days
             (for live vaccines) prior to enrollment in this trial.

         12. Are first degree relatives of individuals involved in trial conduct.

         13. Has a history of autoimmune disease.