Safety and Immunogenicity of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle (VLP) Vaccine in Children
Condition: Norovirus
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      The vaccine being tested in this study is called norovirus GI.1/GII.4 bivalent virus-like
      particle (VLP) vaccine with aluminum hydroxide. 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 children, toddlers and infants
      who are administered different formulations of the norovirus vaccine.

      The study enrolled 840 patients. Participants will be randomly assigned (by chance) to one of
      ten treatment groups-which will remain undisclosed to the participant and study doctor during
      the study (unless there is an urgent medical need).

      All participants in Cohort 1 will be vaccinated on Day 1 and Day 29 of the study, and all
      participants in Cohort 2 will be vaccinated on Day 1, Day 56, and Day 112. All treatment
      groups in Cohort 1 will receive either one dose of the norovirus vaccine, or two doses. One
      treatment group in Cohort 2 will receive 2 doses of the norovirus vaccine, and the other
      group will receive 3. In order to keep the treatment undisclosed to the participant and the
      doctor in Cohort 1, those randomized to the one-dose groups will receive the norovirus
      vaccine on Day 1, followed by a dose of placebo vaccine on Day 29. In order to keep the
      treatment arms undisclosed to the participant and the doctor in Cohort 2, those randomized to
      the two-dose groups will receive the norovirus vaccine on Day 1 and Day 56, followed by a
      dose of placebo vaccine on Day 112. Placebo vaccine is saline solution. 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-center trial will be conducted in Finland, Panama, and Colombia. The overall time
      to participate in this study is up to 210 days for participants in Cohort 1 and up to 293
      Days for participants in Cohort 2. Participants in Cohort 1 will make 6 visits to the clinic,
      and participants in Cohort 2 will make 10 visits to the clinic.
    

Intervention name(s): 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 type(s): Biological; Biological; Biological; Biological; Drug
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Drug therapy