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Набор по приглашению NCT07144202

Study on the Persistence of Immunity Following EV71 Vaccination

— Наблюдательное Hand, Foot, and Mouth Disease Hand, Foot, and Mouth Disease (HFMD)

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Hand, Foot, and Mouth Disease, Hand, Foot, and Mouth Disease (HFMD). Базовые параметры: Без ограничений · 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
Китай
Следующий шаг
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Официальное название

Study on the Immunity Persistence Following Immunization With Enterovirus Type 71 Vaccine, Inactivated (Human Diploid Cell)

Обзор

This is a thirteen-year follow-up study conducted as an extension of a Phase III clinical trial. In this study, a sub-cohort of volunteers who was eligible for enrollment and randomly administrated either 2 dose EV71 vaccine or placebo in the phase III clinical trial was selected to evaluate the EV71 immune levels 13 years after the primary vaccination.

Подробное описание

The initial study was a randomized, double-blind, placebo-controlled phase III clinical trial conducted in children aged 6-71 months from Guilin region of Guangxi Province in 2012. A total of 12000 participants (with 1100 in the immunogenicity group) were randomized in a 1:1 ratio to receive two doses EV71 vaccine or placebo on a 0-, 28-day schedule. Besides, an extended one-year and two year follow-up of this study was completed in 2013.

In this study, immunogenicity group participants from the phase III clinical trial was chosen as the studied subjects. A retrospective survey for the enrolled subjects involved with the history of HFMD and the extra vaccination of EV71 vaccine was conducted before blood collection. 3 ml venous blood were collected from each available subject for EV71 neutralizing antibody (NAb) testing. Since the unblinding was performed after the initial study completed, this study was an open-labelled detection for the persistence of the vaccine-induced EV71 NAb.

Первичные конечные точки

  • Immunogenicity index-seropositive rates of neutralizing antibody [Срок оценки: Year 13 after the second vaccination]
  • Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody [Срок оценки: Year 13 after the second vaccination]

Критерии участия

Критерии включения

  • Included in the immunogenicity group of initial studyand randomly into either vaccine (fulfilled the two doses vaccination following the protocol) or placebo group.
  • Volunteers and their legal guardians or appointed representatives must provide valid legal identification documents.
  • Legal guardians or appointed representatives of volunteers must have the capacity to understand the informed consent document and the research process, voluntarily participate, sign the informed consent form, and be able to comply with the study's requirements.

Критерии исключения

  • Had history of extra EV71 vaccination.
  • Previous history of hand-foot-mouth disease.
  • Participating in other research.
  • Subjects with a hereditary bleeding tendency or coagulopathy, or a history of bleeding disorders.
  • Investigators' Discretion: The final exclusion criterion is the discretion of investigators to determine whether a subject is suitable for participation in the study.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 4 центра
  • Lingchuan Center for Disease Control and Prevention — Guilin
  • Lipu Center for Disease Control and Prevention — Guilin
  • Xing'an Center for Disease Control and Prevention — Guilin
  • Yongfu Center for Disease Control and Prevention — Guilin

Идентификаторы

NCT: NCT07144202 · EV71-402

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗