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Phase III Clinical Trial of Quadrivalent Influenza Virus Split Vaccine

StatusNot Yet Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 30, 2025 (before its estimated July 15, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Study First Submitted
This is a randomized, blinded, active-controlled phase III clinical trial to evaluate the immunogenicity and safety of the Quadrivalent Influenza Virus Split Vaccine (QIV) in subjects (aged 3 years and above). Primary 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, and primary safety 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 endpoints are to evaluate the same index above in different administration programs in children aged 3-8 years.
Trial Details
NCT Number NCT06800950
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, Human Prevention, Influenza a, Influenza B, Influenza Viral Infections
Related terms Influenza, Human
Enrollment 4,400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov