Phase III Clinical Trial of Quadrivalent Influenza Virus Split Vaccine

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.

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	Influenza, Human, Influenza, Human Prevention, Influenza a, Influenza B, Influenza Viral Infections
Enrollment	4,400 participants
Start Date	2025-02-08
Primary Completion	2025-07-15 (estimated)
Study Completion	2025-10-15 (estimated)
Updated on ClinicalTrials.gov	2025-01-30