Clinical Trials of Quadrivalent Influenza Vaccine
ConditionInfluenza, Human
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
The laboratory test indicators specified in the protocol are abnormal and clinically significant before vaccination (only for Phase I);
Have contracted influenza within the past 6 months prior to enrollment (confirmed by any clinical or microbiological method);
Previously or currently suffering from autoimmune or immunodeficiency diseases;
Previous history of severe allergies to any vaccine/drug or any component of the experimental vaccine, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, respiratory distress, angioneurotic edema, or individuals with an allergic constitution (such as allergies to two or more drugs, food, or pollen); History of severe allergy to eggs or egg protein;
Trial design
Design model
Parallel
Treatments tested in this trial
Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant (low dose)
Biological/VaccineInject 1 dose of low-dose vaccine
Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant placebo (low dose)
Biological/VaccineInject 1 dose of low-dose placebo
Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant (high dose)
Biological/VaccineInject 1 dose of high-dose vaccine
Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant placebo (high dose)
Biological/VaccineInject 1 dose of high-dose placebo
Influenza Vaccine (Split Virion), Inactivated, Quadrivalent
Biological/VaccineInject 1 dose of positive control vaccine
Treatment groups
620 Participants
are divided into 14 treatment groups14
Treatment groupsSee each treatment group below.
Group A: Phase I cohort 1 low-dose groupExperimental treatment 1 intervention
Group B: Phase I cohort 1 low-dose placebo groupPlacebo comparator 1 intervention
Group C: Phase I cohort 2 high-dose groupExperimental treatment 1 intervention
Group D: Phase I cohort 2 high-dose placebo groupPlacebo comparator 1 intervention
Group E: Phase I cohort 3 low-dose groupExperimental treatment 1 intervention
Group F: Phase I cohort 3 low-dose placebo groupPlacebo comparator 1 intervention
Group G: Phase I cohort 4 high-dose groupExperimental treatment 1 intervention
Group H: Phase I cohort 4 high-dose placebo groupPlacebo comparator 1 intervention
Group I: Phase II low-dose group (18-49 years old)Experimental treatment 1 intervention
Group J: Phase II high-dose group (18-49 years old)Experimental treatment 1 intervention
Group K: Phase II positive control group (18-49 years old)Active comparator 1 intervention
Group L: Phase II low-dose group (50 years old and above)Experimental treatment 1 intervention
Group M: Phase II high-dose group (50 years old and above)Experimental treatment 1 intervention
Group N: Phase II positive control group (50 years old and above)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
AE occurren
Number and incidence of all adverse events
Time frame
within 30 days after vaccination2
AESI occurrences
Number and incidence of all adverse events of special interest
Time frame
within 30 days after vaccination3
SAE occurrences
Number and incidence of all serious adverse events
Time frame
within 12 months after vaccination4
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 vaccinationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov