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Само по покана Фаза 4 NCT07545564

A Study on Mucosal Specific IgA Immunokinetics After Administration of Nasal Spray Live Attenuated Influenza Vaccine

Фаза 4 – наблюдение след одобрението на пазара
Заболявания: Influenza

Спонсор: Changchun BCHT Biotechnology Co.

Налично на: БГ
Обобщение
Mucosal-specific sIgA antibody GMT;Evaluate the achievement of 2-fold and 4-fold increases in the geometric mean titer (GMT) of specific nasal mucosal sIgA antibodies after vaccination
Кой може да участва
Inclusion Criteria: * People aged 3 to 17 years old who voluntarily receive the live attenuated influenza nasal spray vaccine; * The participant themselves can comply with the protocol requirements and complete sample collection; * Obtain the consent of the participants' guardians and sign the informed consent form; Exclusion Criteria: * Axillary temperature \> 37.0°C on the day of enrollment; * Received any influenza vaccine within the past 2 years and plans to receive other influenza vaccines during the trial period; * Clinically diagnosed with influenza in a medical institution within the past year (with confirmed etiological diagnosis); * Individuals with known hypersensitivity to any ingredient contained in this product, including eggs, excipients, and gentamicin sulfate; * Individuals suffering from acute diseases, severe chronic diseases, acute exacerbations of chronic diseases, and fever; * Pregnant women; * Patients with Leigh syndrome who are being treated with aspirin or aspirin-containing medications; * Individuals with immunodeficiency or those undergoing immunosuppressive therapy; * Individuals with uncontrolled epilepsy and other progressive neurological diseases, or those with a history of Guillain-Barré syndrome; * Nasal abnormalities that, in the judgment of a clinician, may affect vaccination, individuals in the medication period for allergic rhinitis, or those currently receiving nasal spray administration; * Having received a live attenuated vaccine within 14 days prior to enrollment, or a subunit or inactivated vaccine within 7 days prior to enrollment; * Presence of other factors deemed unsuitable for participation in this study by the investigator.
Интервенции
LAIV
BIOLOGICAL
Placebo
BIOLOGICAL
Места на провеждане 1
Китай (1)
Neimenggu CDC
Hohhot , Inner Mongolia
Технически детайли
Статус
Само по покана
Фаза
Фаза 4
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
3 Years
Максимална възраст
17 Years
Здрави доброволци
Не
Начална дата
09.04.2026
Крайна дата
09.05.2026
Регистрационен номер
NCT07545564
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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