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Safety and Immunogenicity Study of Recombinant Trivalent Rotavirus Subunit Vaccine in Healthy Infants and Toddlers

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study completion date: Apr 2024 to Dec 2024v4
  2. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Apr 2023 to Apr 29, 2023
    • Site details revised at 2 of 2 sites
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 2022 to Jan 8, 2023
    • Site details revised at 2 of 2 sites
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to assess the immunogenicity, safety and immune persistence of recombinant trivalent rotavirus subunit vaccine in healthy infants aged 6-12 weeks and healthy toddlers aged 7-71 months.
Trial Details
NCT Number NCT05621655
Lead Sponsor MAXVAX Biotechnology Limited Liability Company
Collaborators: Henan Center for Disease Control and Prevention
Conditions
(from sponsor)		 Rotavirus Infections, Rotavirus Gastroenteritis
Related terms Gastroenteritis, Rotavirus Infections
Enrollment 1,512 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov