Testing a new quadrivalent influenza vaccine for safety and effectiveness

A Randomized, Blinded Phase I./II Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of Influenza Vaccine (Split Virion), Inactivated, Quadrivalent, ZFA02 Adjuvant

This study is testing a new flu vaccine to see if it's safe and effective for adults aged 18 and older.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 620 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. (industry)
• Locations: 1 site (Shijiazhuang, Hebei)
• Trial ID: NCT06824519 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and tolerability of a quadrivalent influenza vaccine through a seamless Phase I/II design. Phase I involves age and dose escalation with 120 participants aged 18 and older, while Phase II expands to 500 participants divided into two age groups. The study employs a randomized, blinded, placebo-controlled approach to assess immunogenicity and determine the optimal vaccine dose for future trials.

Who should consider this trial

Good fit: Ideal candidates include healthy adults aged 18 and older who are willing to participate in the trial and meet the inclusion criteria.

Not a fit: Patients with a history of severe allergies to vaccines or those with autoimmune or immunodeficiency diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this vaccine could provide enhanced protection against influenza for various age groups.

How similar studies have performed: Other studies have shown success with similar quadrivalent influenza vaccines, indicating a promising approach.

Eligibility criteria

Inclusion Criteria:

1. When signing the informed consent form, be at least 18 years old and provide valid identification;
2. 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;
3. On the day of enrollment, axillary temperature was ≤ 37.0 ℃;
4. Female and male participants of childbearing age: agree to take effective contraceptive measures within 6 months after vaccination.

Exclusion Criteria:

1. The laboratory test indicators specified in the protocol are abnormal and clinically significant before vaccination (only for Phase I);
2. Have contracted influenza within the past 6 months prior to enrollment (confirmed by any clinical or microbiological method);
3. Previously or currently suffering from autoimmune or immunodeficiency diseases;
4. 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;
5. Have received any influenza vaccine within the 6 months prior to enrollment, or plan to receive influenza vaccine other than the vaccine used in this trial during the trial period (before completing the immunization and collecting blood samples);
6. Within 30 days prior to enrollment, any investigational or unregistered products (drugs, vaccines, or devices) have been used, or are planned to be used during the trial period (except for the vaccine used in this trial) (before completing the immunization and collecting blood samples);
7. The interval between receiving attenuated live vaccines before enrollment is less than 30 days, and the interval between receiving other non live vaccines is less than 14 days;
8. Within the first 3 days of enrollment, have experienced acute illness or are in the acute phase of chronic illness;
9. Used antipyretic, analgesic, or anti allergic drugs within 3 days prior to enrollment;
10. Use immunoglobulin and/or any blood products within 3 months prior to enrollment, or plan to use them during the trial period (before completing immunization and collecting blood samples);
11. Long term use of immunosuppressants or other immunomodulatory drugs (defined as continuous use for more than 14 days) within the first 3 months of enrollment, such as a glucocorticoid dose of ≥ 0.5 mg/kg/day (inhalation and local steroid hormones are not restricted);
12. Absence of spleen, functional absence of spleen, and splenectomy caused by any condition;
13. Any obvious coagulation dysfunction or history of anticoagulant therapy;
14. History of epilepsy, encephalopathy, and malignant tumors;
15. Suffering from serious cardiovascular system diseases, serious hypertension with unstable drugs (systolic pressure ≥ 160mmHg and/or diastolic pressure ≥ 100mmHg), diabetes with serious complications and other serious chronic diseases;
16. Currently suffering from respiratory system diseases (including pneumonia, tuberculosis, severe asthma, chronic bronchitis, etc.), acute liver and kidney diseases (severe impairment of liver and kidney function), mental disorders (such as schizophrenia, depression, affective disorders, etc.), etc;
17. Women of childbearing age who are breastfeeding, pregnant, or have a positive urine pregnancy test before enrollment;
18. Plan to move out of the local area before the end of the study or plan to leave the local area for a long time during the study visit;
19. According to the researchers' judgment, the subjects have any other factors that are not suitable for participating in the clinical trial.

Where this trial is running

Shijiazhuang, Hebei

• Hebei Province Centers for Disease Control and Prevention — Shijiazhuang, Hebei, China (RECRUITING)

Study contacts

• Principal investigator: Fei Jin — Hebei Province Centers for Disease Control and Prevention
• Study coordinator: Fei Jin

Conditions: Influenza, Human