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NOT YET RECRUITING
NCT06800950
PHASE3

Phase III Clinical Trial of Quadrivalent Influenza Virus Split Vaccine

Sponsor: Institute of Medical Biology, Chinese Academy of Medical Sciences

View on ClinicalTrials.gov

Summary

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.

Official title: A Randomized, Blinded, Positive-controlled Phase III Clinical Trial of Quadrivalent Influenza Vaccine (split Virion) in People Aged 3 Years and Above

Key Details

Gender

All

Age Range

3 Years - Any

Study Type

INTERVENTIONAL

Enrollment

4400

Start Date

2025-02-08

Completion Date

2025-10-15

Last Updated

2025-01-30

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

QIV

Quadrivalent Influenza Virus Split Vaccine containing H1N1, H3N2, Bv, By antigens of 0.5ml for each dose

BIOLOGICAL

QIV Control

Quadrivalent Influenza Virus Split Vaccine containing each type of antigens of 0.5ml for each dose

Locations (3)

Xing'an Center for Disease Control and Prevention

Guilin, Guangxi, China

Yangshuo Center for Disease Control and Prevention

Guilin, Guangxi, China

Binyang Center for Disease Control and Prevention

Nanning, Guangxi, China