A Randomized, Blinded Phase I./II Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
This clinical trial adopts a seamless design of phase I/II, conducted in two stages: phase I and phase II. Phase I is the age/dose ramp up stage, and phase II is the dose expansion stage.The purpose of this clinical trial is to evaluate the safety and tolerability of different doses of Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant，explore the immunogenicity of the vaccine, and determine the appropriate dose for later clinical trials of this product.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:
• When signing the informed consent form, be at least 18 years old and provide valid identification;
• The subject is able to understand the procedures and methods of this clinical trial, has given sufficient informed consent, voluntarily participated, and signed an informed consent form by the subject themselves;
• On the day of enrollment, axillary temperature was ≤ 37.0 ℃;
• Female and male participants of childbearing age: agree to take effective contraceptive measures within 6 months after vaccination.
Locations
Other Locations
China
Hebei Province Centers for Disease Control and Prevention
RECRUITING
Shijiazhuang
Contact Information
Primary
Fei Jin
ycjf3000@126.com
13722795742
Time Frame
Start Date:2025-05-08
Estimated Completion Date:2026-09
Participants
Target number of participants:620
Treatments
Experimental: Phase I cohort 1 low-dose group
20 subjects aged 18-49 were enrolled and randomly assigned to the low-dose experimental group, and received one dose of the low-dose experimental vaccine.
Placebo_comparator: Phase I cohort 1 low-dose placebo group
10 subjects aged 18-49 were enrolled and randomly assigned to the low-dose placebo group, and received one dose of the low-dose placebo.
Experimental: Phase I cohort 2 high-dose group
20 subjects aged 18-49 were enrolled and randomly assigned to the high-dose experimental group, and received one dose of the high-dose experimental vaccine.
Placebo_comparator: Phase I cohort 2 high-dose placebo group
10 subjects aged 18-49 were enrolled and randomly assigned to the high-dose placebo group, and received one dose of the high-dose placebo.
Experimental: Phase I cohort 3 low-dose group
20 subjects aged 50 and above were enrolled and randomly assigned to the low-dose experimental group, and received one dose of the low-dose experimental vaccine.
Placebo_comparator: Phase I cohort 3 low-dose placebo group
10 subjects aged 50 and above were enrolled and randomly assigned to the low-dose placebo group, and received one dose of the low-dose placebo.
Experimental: Phase I cohort 4 high-dose group
20 subjects aged 50 and above were enrolled and randomly assigned to the high-dose experimental group, and received one dose of the high-dose experimental vaccine.
Placebo_comparator: Phase I cohort 4 high-dose placebo group
10 subjects aged 50 and above were enrolled and randomly assigned to the high-dose placebo group, and received one dose of the high-dose placebo.
Experimental: Phase II low-dose group (18-49 years old)
100 subjects aged 18-49 were enrolled and randomly assigned to the low-dose experimental group, and received one dose of the low-dose experimental vaccine.
Experimental: Phase II high-dose group (18-49 years old)
100 subjects aged 18-49 were enrolled and randomly assigned to the high-dose experimental group, and received one dose of the high-dose experimental vaccine.
Active_comparator: Phase II positive control group (18-49 years old)
50 subjects aged 18-49 were enrolled and randomly assigned to the positive control group, and received one dose of the positive control vaccine.
Experimental: Phase II low-dose group (50 years old and above)
100 subjects aged 50 and above were enrolled and randomly assigned to the low-dose experimental group, and received one dose of the low-dose experimental vaccine.
Experimental: Phase II high-dose group (50 years old and above)
100 subjects aged 50 and above were enrolled and randomly assigned to the high-dose experimental group, and received one dose of the high-dose experimental vaccine.
Active_comparator: Phase II positive control group (50 years old and above)
50 subjects aged 50 and above were enrolled and randomly assigned to the positive control group, and received one dose of the positive control vaccine.