Phase I Clinical Trial of Quadrivalent Influenza Virus Split Vaccine

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.

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	Influenza, Human, Influenza a, Influenza Type B, Influenza Viral Infections
Enrollment	180 participants
Start Date	2024-10-13
Primary Completion	2025-01-09 (estimated)
Study Completion	2025-07-31 (estimated)
Updated on ClinicalTrials.gov	2025-01-28