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Набира участници Фаза 3 NCT07054099

A Study to Evaluate Immunogenicity and Safety After the First and Second Doses of MG1111 (BARYCELA Inj.) in Healthy Children Aged 12 Months to 12 Years

Фаза 3 – широко изпитване преди одобрение
Заболявания: Varicella (Chickenpox) Chickenpox Vaccine

Спонсор: GC Biopharma Corp

Налично на: БГ
Обобщение
This clinical study aims to evaluate the safety and immune response of MG1111, in healthy children compared to VARIVAX. The study will follow participants for 42 days after receiving two doses, with additional follow-ups for up to 10 years to monitor varicella infection.
Кой може да участва
Inclusion Criteria: * Participant must be 12 months to 12 years of age, inclusive, at the time of signing the informed consent or assent. * Participant is overtly healthy as determined by the investigator Exclusion Criteria: * Participants with a history of exposure to varicella through contact with a varicella patient at home, school, or childcare facility within 4 weeks before Screening * Participants with a history of varicella infection and varicella vaccine, either licensed or investigational, and either standalone or any combination, such as MMRV * Participants with acute moderate or severe infection with or without fever at the time of dosing * Participants who have had any suspected allergy symptoms, such as systemic rash, during the 72 hours before each administration of investigational product
Интервенции
MG1111 (Barycela inj.)
BIOLOGICAL
VARIVAX™
BIOLOGICAL
Места на провеждане 1
Тайланд (1)
Srinagarind Hospital
Khon Kaen , Changwat Khon Kaen
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
12 Months
Максимална възраст
12 Years
Здрави доброволци
Не
Начална дата
17.03.2026
Крайна дата
01.07.2036
Регистрационен номер
NCT07054099
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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