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Efficacy, Safety, and Immunogenicity of the Bivalent Inactivated Enterovirus Vaccine (Vero Cell)

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 1, 2025 (before its estimated November 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 4
    • Start date changed from estimate of Dec 30, 2024 to Dec 13, 2024
    v2
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This multicenter, randomized, double-blind, controlled Phase III clinical trial aims to evaluate the efficacy, safety, and immunogenicity of the bivalent enterovirus-inactivated vaccine (Vero cell) in healthy children aged 6 to 71 months. The main questions it aims to answer are: * The primary vaccine efficacy of the investigational vaccine against Hand, Foot, and Mouth Disease（HFMD) caused by CA16 infection compared to the control vaccine. * The neutralizing antibody levels against EV71 in the trial group are non-inferior to those in the control group after two doses of vaccination. Researchers will compare the bivalent enterovirus-inactivated vaccine (Vero cell) to the EV71-inactivated vaccine (Vero cell) to prevent HFMD and Herpangina(HA). Participants will be randomly assigned to the trial group and the control group in a 1:1 ratio to receive two doses of the investigational vaccine or the control EV71 vaccine, with a one-month interval between doses.
Trial Details
NCT Number NCT06734832
Lead Sponsor Sinovac Biotech Co., Ltd
Conditions
(from sponsor)		 Hand, Foot, and Mouth Disease（HFMD)
Related terms Hand, Foot and Mouth Disease
Enrollment 8,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov