Phase Ⅱ Clinical Trial of Influenza Virus Split Vaccine for Individuals Aged 60 Years and Above

Официальное название

A Randomized, Double-blind, Active-controlled Phase Ⅱ Clinical Trial to Evaluate the Immunogenicity and Safety of the Influenza Virus Split Vaccine for Individuals Aged 60 Years and Above

Обзор

To evaluate the immunogenicity of administering one dose of influenza virus split vaccine (0.7mL/dose) to individuals aged 60 and above.

Подробное описание

This is a randomized, blinded, parallel controlled trial design, a total of 1200 participants aged ≥ 60 years were enrolled in the study. Study participants were randomly vaccinated with either the experimental vaccine: influenza virus split vaccine (0.7mL/dose) or the control vaccine: influenza virus split vaccine, at a 1:1 ratio. One dose of the vaccine was administered on day 0 for immunogenicity and safety evaluation.

Вмешательства

• Биопрепарат Influenza virus split vaccine (0.7mL/vial)
  Influenza virus split vaccine, with a specification of 0.7mL/bottle, containing 60 μ g of hemagglutinin from H1N1, H3N2, and B influenza virus strains each Control: Influenza virus split vaccine.
• Биопрепарат Influenza virus split vaccine
  Influenza virus split vaccine, with a specification of 0.5mL/bottle, containing 15 μ g of hemagglutinin from H1N1, H3N2, and B influenza virus strains each.

Первичные конечные точки

• Seroconversion rate [Срок оценки: 30 days after vaccination]
• Ratio of ≥1:40 [Срок оценки: 30 days after vaccination]
• Geometric mean titer (GMT) [Срок оценки: 30 days after vaccination]
• Geometric mean increase (GMI) [Срок оценки: 30 days after vaccination]

Вторичные конечные точки (3)

• Solicited Adverse Events (AEs) [Срок оценки: 7 days after vaccination]
• Unsolicited Adverse Events [Срок оценки: 30 days after vaccination]
• Serious Adverse Events (SAEs) [Срок оценки: 6 months after vaccination]

Критерии участия

Критерии включения

• Age over 60 years old, gender not limited, and able to provide legal identification;
• Volunteers voluntarily participate in the study and sign an informed consent form;
• Volunteers have the ability to understand research procedures, use thermometers, scales, and fill out diary cards as required, and can participate in all planned follow-up visits.

Критерии исключения

• On the day of enrollment, the axillary temperature was ≥ 37.3 ℃;
• Those who have had influenza in the past 6 months or meet the definition of influenza like cases;
• Have received any influenza vaccine within the past 12 months or have planned to receive any influenza vaccine during the study period;
• Allergies to any components of the research vaccine, history of allergic reactions to the use of gentamicin sulfate, history of severe allergies to any vaccine/drug, or history of asthma;
• Suffering from a serious illness that prevents the completion of the entire study; Within 3 days prior to vaccination, there is an acute illness or an acute exacerbation of a chronic disease;
• Have used antipyretic or analgesic drugs or anti allergic drugs within 3 days before vaccination;
• Have received any vaccine within 2 weeks prior to vaccination;
• Have received immunosuppressive therapy or other immunomodulatory drugs within 6 months prior to receiving the experimental vaccine, For example, immunosuppressive doses of glucocorticoids, monoclonal antibodies, thymosin, interferon, etc., or planned to receive such treatment within one month after the first dose of vaccination to full immunization, but local medication is allowed;
• Suffering from congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, or other autoimmune diseases;
• Suffering from serious chronic diseases, serious cardiovascular diseases, such as hypertension that cannot be controlled by drugs, diabetes that cannot be controlled by drugs or has serious complications, liver and kidney diseases, pulmonary edema, malignant tumors, etc;
• Have received blood or blood related products within the past 6 months;
• Individuals with progressive neurological disorders, including a history of seizures, epilepsy, encephalopathy, Guillain Barr é syndrome, psychiatric or family history;
• Have a history of abnormal coagulation function and have been using anticoagulants within 3 weeks before vaccination;
• Patients with splenectomy, functional splenectomy, splenectomy, or other important organ resection or partial resection;
• Plan to move before the end of the study or leave the local area for a long time during the scheduled study visit;
• Currently or recently planning to participate in other clinical trials;
• Researchers determine any situation that is not suitable for clinical trials.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

Китай · 2 центра

• Danjiangkou City Center for Disease Control and Prevention — Ухань
• Yunxi County Center for Disease Control and Prevention — Ухань

Идентификаторы

NCT: NCT07327398 · SIBP-V05-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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