Phase III Clinical Trial of Quadrivalent Influenza Virus Split Vaccine
Condition(s) studied
Investigational drug(s) / intervention(s)
QIV: Quadrivalent Influenza Virus Split Vaccine containing H1N1, H3N2, Bv, By antigens of 0.5ml for each dose
QIV Control: Quadrivalent Influenza Virus Split Vaccine containing each type of antigens of 0.5ml for each dose
Study 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.
Eligibility
Primary outcome measure(s)
- Immunogenicity index - seroconversion rates of HI antibody against all types — Between baseline and Day 30 after full vaccination
Antibody assay will be performed using the hemagglutination inhibition test. Seroconversion will be defined as a change from seronegative (Antibody titers\<1:40) to seropositive (Antibody titers≥1:40), or a ≥4-fold increase from baseline. - Immunogenicity index - Seropositive rates of HI antibody against all types — Day 30 after full vaccination
Antibody assay will be performed using the hemagglutination inhibition test. Seropositive is defined as antibody titers≥1:40 - Immunogenicity index - geometric mean titer (GMT) of HI antibody against all types — Day 30 after full vaccination
Antibody assay will be performed using the hemagglutination inhibition test. - Safety index - incidence of adverse events/adverse reactions — Day 0 to 7 after the first dose vaccination
Incidence of adverse events/adverse reactions after the first dose vaccination - Safety index - incidence of adverse events/adverse reactions — Day 0 to 7 after the second dose vaccination
Incidence of adverse events/adverse reactions after the second dose vaccination (applicable for the two-dose children cohort) - Safety index - incidence of adverse events/adverse reactions — From Day 0 to Day 30 after full vaccination
Incidence of adverse events/adverse reactions after full vaccination
Trial sites (3)
| Facility | City | Region | Status |
|---|---|---|---|
| Xing'an Center for Disease Control and Prevention | Guilin | Guangxi | |
| Yangshuo Center for Disease Control and Prevention | Guilin | Guangxi | |
| Binyang Center for Disease Control and Prevention | Nanning | Guangxi |
More Institute of Medical Biology, Chinese Academy of Medical Sciences trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06800950 on ClinicalTrials.gov ↗ ← All trials in China