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.
Age Requirement: volunteers aged 3 years and above at the time of enrollment.
Provision of Legal Identification: Volunteers and their legal guardians or appointed representatives must provide valid legal identification documents.
Informed Consent: Volutters, legal guardians, or appointed representatives of volunteers must have the capacity to understand the informed consent document and the research process, voluntarily participate, sign the informed consent form, and be able to comply with the requirements in the study as well as complete relevant visits on time.
Requirements for contraception: agree to take contraception actions in 6 months.
Subjects with a history of severe allergy to egg or egg protein, such as those who have had symptoms such as angioedema, dyspnea, chest distress, or repeated vomiting due to eating eggs, and even those who have used epinephrine or other emergency medical treatment, especially those who have symptoms immediately or within a short period (minutes to hours).
Subjects with influenza illness (clinically, serologically, or microbiologically confirmed) within 6 months before screening and enrollment.
Have received an influenza vaccine within 1 year before enrollment or scheduled to receive another influenza vaccine during the study period.
Allergic to any component contained in the investigational vaccine, or previous history of severe allergic to any vaccine or drug, such as anaphylactic shock, laryngeal edema, anaphylactic purpura, thrombocytopenic purpura, local allergic necrosis reaction, dyspnea, angioedema, systemic rash and/or urticaria, etc.
Parallel
QIV
Biological/VaccineQuadrivalent Influenza Virus Split Vaccine containing H1N1, H3N2, Bv, By antigens of 0.5ml for each dose
QIV Control
Biological/VaccineQuadrivalent Influenza Virus Split Vaccine containing each type of antigens of 0.5ml for each dose
7
Treatment groupsSee each treatment group below.
Immunogenicity index - seroconversion rates of HI antibody against all types
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
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
Antibody assay will be performed using the hemagglutination inhibition test.
Safety index - incidence of adverse events/adverse reactions
Incidence of adverse events/adverse reactions after the first dose vaccination
Safety index - incidence of serious adverse events/adverse reactions
Incidence of serious adverse events/adverse reactions after vaccination
Immunogenicity index - seroconversion rates of HI antibody against all types
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. (Applicable for susceptible cohort)
Immunogenicity index - Seropositive rates of HI antibody against all types
Antibody assay will be performed using the hemagglutination inhibition test. Seropositive is defined as antibody titers≥1:40 (Applicable for susceptible cohort)
Immunogenicity index - geometric mean titer (GMT) of HI antibody against all types
Antibody assay will be performed using the hemagglutination inhibition test. (Applicable for susceptible cohort)
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Institute of Medical Biology, Chinese Academy of Medical Sciences
Lead sponsor
Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
