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Phase I Clinical Trial of Quadrivalent Influenza Virus Split Vaccine

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Dec 31, 2024 to Jan 9, 2025
    • Site contact updated
    • Collaborator revised
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is a randomized, blinded, active-controlled phase I clinical trial to evaluate the safety and preliminary immunogenicity of the Quadrivalent Influenza Virus Split Vaccine (QIV) in subjects (aged 3 years and above). Primary endpoints are the occurrence of safety events after vaccination including the incidence of adverse events/adverse reactions within 30 minutes/7 days/30 days after immunization, as well as the incidence of serious adverse events/adverse relations within 6 months which will be defined as the secondary safety endpoint. Besides, the secondary immunogenicity endpoints are the geometric mean titers, geometric mean fold increases, seropositive rates, and seroconversion rates of anti-influenza virus HI antibodies for all types 30 days after immunization.
Trial Details
NCT Number NCT06622590
Lead Sponsor Institute of Medical Biology, Chinese Academy of Medical Sciences
Collaborators: Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control
Conditions
(from sponsor)		 Influenza, Human, Influenza a, Influenza Type B, Influenza Viral Infections
Related terms Influenza, Human
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov