Меню
Идёт набор NCT07621653

Post Marketing Surveillance Study for MenQuadfi® [Meningococcal (Groups A, C, Y, W) Polysaccharide Tetanus Toxoid Conjugate Vaccine] Administered in Participants Aged 6 Weeks to 55 Years in Republic of Korea

— Наблюдательное Meningococcal Immunization Healthy Volunteers

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Meningococcal (Groups A, C, Y, W) Polysaccharide Tetanus Toxoid Conjugate Vaccine.
Кому может быть актуально
Состояния в реестре: Meningococcal Immunization, Healthy Volunteers. Базовые параметры: 6 Weeks — 55 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
South Korea
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

This surveillance is to investigate the safety profile of MenQuadfi®, when administered to participants aged 6 weeks to 55 years under the real-world clinical practice settings as per approved indications, including the Adverse Drug Reactions (ADRs)\*. \*It includes ADRs that were not fully recognized in clinical practice, or unexpected ADRs which refer to those not listed in the approved drug labeling.

Вмешательства

  • Биопрепарат Meningococcal (Groups A, C, Y, W) Polysaccharide Tetanus Toxoid Conjugate Vaccine
    This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practice.

Первичные конечные точки

  • Number of participants with solicited injection site and systemic reactions [Срок оценки: Up to 7 days after vaccination]
  • Number of participants with unsolicited non-serious Adverse Events (AEs) and Adverse Drug Reactions (ADRs), including unexpected AEs and ADRs [Срок оценки: Up to 30 days after vaccination]
  • Number of participants with Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI), and Serious Adverse Drug Reactions (SADRs) [Срок оценки: From Day 01 up to the end of the study (approximately 44 days after inclusion in individuals aged 2-55 years; approximately 4 months in infants aged 6 months to <24 months; approximately 13 months in infants aged 6 weeks to <6 months)]

Критерии участия

Критерии включения

  • Aged 6 weeks to 55 years on the day of MenQuadfi® vaccination
  • Evidence of a personally signed and dated informed consent document indicating that the participant or their parent(s)/other legally acceptable representative(s), if applicable, have been informed of all pertinent aspects of the study
  • Participants who have been vaccinated with MenQuadfi® for the first time as per ordinary healthcare setting at the day of inclusion in the study according to the approved local product label

Критерии исключения

  • Participating or planning participation in any other clinical studies investigating a vaccine, drug, medical device, or medical procedure at the time of the study enrolment (or in 4 weeks preceding the enrolment)
  • Having a previous history of enrollment in this study (participants who have already been enrolled once in this study are not eligible for re-enrollment)
  • Being applicable to contraindications in the approved local product label of MenQuadfi®; anyone with a known systemic hypersensitivity reaction to any component of this vaccine or after previous administration of the vaccine or a vaccine containing the same components

Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

South Korea · 9 центров
  • Investigational Site Number: 410009 — Busan
  • Investigational Site Number: 410011 — Daegu
  • Investigational Site Number: 410003 — Goyang
  • Investigational Site Number: 410008 — Gwangju
  • Investigational Site Number: 410010 — Hanam
  • Investigational Site Number: 410006 — Iksan
  • Investigational Site Number: 410005 — Seongnam
  • Investigational Site Number: 410004 — Seoul
  • … и ещё 1 центр

Идентификаторы

NCT: NCT07621653 · MEQ00085 · U1111-1317-8004

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗