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
Qualifiers
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
Treatments tested in this trial
- Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant (low dose)
- Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant placebo (low dose)
- Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant (high dose)
- Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant placebo (high dose)
- Influenza Vaccine (Split Virion), Inactivated, Quadrivalent
Treatment groups
620 Participants
are divided into 14 treatment groups14
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov