Influenza, Human, Influenza, Human Prevention, Influenza a, Influenza B, Influenza Viral Infections
Conditions
Brief 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.
Detailed description
This is a randomized, blinded, active-controlled phase III clinical trial to evaluate the immunogenicity and safety in 4400 subjects (aged 3 years and above). Then 1760 children (aged 3-8 years), 1320 adults/adolescents (aged 9-59 years), and 1320 elders (aged 60 years and above) are eligible for enrollment after assessing the medical history and physical examination. 1760 children's strata contains 1320 children with no history of influenza vaccine and 440 children with a history of influenza vaccine. Those 1320 children to the 2-dose vaccine, 1-dose vaccine, and control group in a ratio of 1:1:1, that is 440 subjects in the 2-dose vaccine cohort will receive 2 doses of experimental vaccines in a 0,28 program, and 440 subjects in the 1-dose vaccine or control cohort will receive 1 dose of experimental or active-controlled vaccine. The rest of the 440 children with a history of influenza vaccine will be randomly assigned to a 1-dose vaccine and control group in a ratio of 1:1, that is 220 subjects in the 1-dose vaccine or control cohort will receive 1 dose of experimental or active-controlled vaccine. 1320 adults/adolescents will be randomly assigned to a 1-dose vaccine and control group in a ratio of 1:1, that is 660 subjects in the 1-dose vaccine or control cohort will receive 1 dose of experimental or active-controlled vaccine. 1320 elders will be randomly assigned to a 1-dose vaccine and control group in a ratio of 1:1, that is 660 subjects in the 1-dose vaccine or control cohort will receive 1 dose of experimental or active-controlled vaccine. The duration of intervention is no more than 1 month. With the 6-month safety monitoring after administration, the duration of the study is no more than 7 months. For immunogenicity assessment, antibodies against all vaccine-related types of Influenza virus will be assessed in all subjects before vaccination and 30 days after full vaccination. For safety assessment, the observation and evaluation of adverse events from Day 0 to Day 30 after each dose will be conducted by diary/contact cards and investigators' phone calls. Besides, the observation and evaluation of serious adverse events up to 6 months after vaccination will be conducted by active reports by subjects' legal guardians, or investigators' phone calls as well as face-to-face visits. Meanwhile, subjects will be observed at the site for at least 30 minutes after each dose. For laboratory examination, urine routine tests or urine pregnancy tests (if applicable) will be performed on Day 0 before vaccination.
Interventions
BIOLOGICALQIV
Quadrivalent Influenza Virus Split Vaccine containing H1N1, H3N2, Bv, By antigens of 0.5ml for each dose
BIOLOGICALQIV Control
Quadrivalent Influenza Virus Split Vaccine containing each type of antigens of 0.5ml for each dose
Sponsors
Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control
Institute of Medical Biology, Chinese Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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. * Temperature Requirement: Axillary body temperature is less than 37.3°C. * Previous Vaccination Requirements: (a) Received at least 1 dose of influenza vaccine within 1 year before screening in children aged 3-8 years; (b) Never received any influenza vaccine 1 year before screening in children aged over 3 years.
Exclusion criteria
Subjects meeting any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety index - incidence of serious adverse events/adverse reactions | From the beginning of the vaccination up to 6 months after the last vaccination completed | Incidence of serious adverse events/adverse reactions after vaccination |
| 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. (Applicable for susceptible cohort) |
| 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 (Applicable for susceptible cohort) |
| 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. (Applicable for susceptible cohort) |
Countries
China
Contacts
Primary ContactGuoyang Liao
Outcome results
None listed