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.
Overall design: Adopting a randomized, blinded research design. This experiment adopts a seamless connection design of Phase I/II, conducted in two stages: Phase I and Phase II. Phase I is the age/dose escalation stage, and Phase II is the dose extension stage. Age/dose escalation stage: A randomized, blinded, placebo-controlled study design was used. 120 subjects were enrolled in the study, in order of age from 18 to 49 years old to 50 years old and above, from low dose to high dose. They were divided into four cohorts, with 30 subjects in each cohort (including 20 who received high-dose or low-dose experimental vaccines and 10 who received placebo). The first 6 subjects in each cohort were assigned to be sentinel group, and the researchers reviewed the safety data of the sentinel group within 7 days after vaccination. After confirming safety (not meeting the criteria for suspending/terminating the trial), the remaining 24 subjects in the cohort were enrolled. Dose expansion stage: A randomized, blinded, positive controlled study design was used. 500 subjects were enrolled, divided into two age groups: 18-49 years old and 50 years old and above. 250 subjects were enrolled in each age group and randomly divided into low-dose group, high-dose group, and positive control group according to a 2:2:1 ratio. The proportion of people aged 60 and above in the population aged 50 and above shall not be less than 80%, and the proportion of people aged 70 and above shall not be less than 30%.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Inject 1 dose of low-dose vaccine
Inject 1 dose of low-dose placebo
Inject 1 dose of high-dose vaccine
Hebei Province Centers for Disease Control and Prevention
Shijiazhuang, Hebei, China
RECRUITINGAE occurren
Number and incidence of all adverse events
Time frame: within 30 days after vaccination
AESI occurrences
Number and incidence of all adverse events of special interest
Time frame: within 30 days after vaccination
SAE occurrences
Number and incidence of all serious adverse events
Time frame: within 12 months after vaccination
Serum alanine aminotransferase level
All participants in Phase I were tested for alanine aminotransferase levels before and on the 4th day after vaccination
Time frame: on the 4th day after vaccination
Serum aspartate transaminase level
All participants in Phase I were tested for aspartate transaminase levels before and on the 4th day after vaccination
Time frame: on the 4th day after vaccination
Serum total bilirubin level
All participants in Phase I were tested for total bilirubin levels before and on the 4th day after vaccination
Time frame: on the 4th day after vaccination
Serum white blood cell level
All participants in Phase I were tested for white blood cell levels before and on the 4th day after vaccination
Time frame: on the 4th day after vaccination
Serum platelet level
All participants in Phase I were tested for platelet levels before and on the 4th day after vaccination
Time frame: on the 4th day after vaccination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Enrollment
620
Inject 1 dose of high-dose placebo
Inject 1 dose of positive control vaccine
Serum hemoglobin level
All participants in Phase I were tested for hemoglobin levels before and on the 4th day after vaccination
Time frame: on the 4th day after vaccination
Urinary protein level in urine
All participants in Phase I were tested for urinary protein levels in urine before and on the 4th day after vaccination
Time frame: on the 4th day after vaccination
Urinary red blood cell level in urine
All participants in Phase I were tested for urinary red blood cell levels in urine before and on the 4th day after vaccination
Time frame: on the 4th day after vaccination
Serum antibody level
Detect the levels of hemagglutination inhibition (HI) antibodies against influenza viruses H1N1, H3N2, and type B (B/Victoria and B/Yamagata).
Time frame: 30 days after vaccination