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Идёт набор NCT05758532

Non-specific Effects of a Modified Measles Vaccination Schedule to Prevent Allergy and Unrelated Infection in Children

Фаза IV С лечением Respiratory Tract Infections Infections Allergy Eczema

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: Measles-Mumps-Rubella vaccine (MMR).
Кому может быть актуально
Состояния в реестре: Respiratory Tract Infections, Infections, Allergy, Eczema. Базовые параметры: 6 мес. — 6 мес. · 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
Швейцария
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Harnessing the Beneficial Non-specific Effects of Measles-mumps-rubella Vaccine in Children on Infection With Unrelated Pathogens and Allergic Diseases - a Single-centre Phase IV RCT With a Factorial Design

Обзор

The goal of this clinical trial is to evaluate the off-target/non-specific effects of the measles-mumps-rubella (MMR) vaccine in children.

Подробное описание

The overall objective of this project is to assess, in a randomised control trial (RCT), the effects of a "modified" MMR schedule in children, by an in-depth characterisation of both the clinical effects and the underlying immunomodulatory changes.

The current Swiss administration schedule of giving MMR at 9 and 12 months of age ("current schedule") will be compared with a "modified schedule". This is expected to maximise the beneficial non-specific effects of MMR by giving it at 6 and 13 months of age, separately from other vaccines ("modified schedule"). Factorial analysis will enable assessment of the benefit of the intervention on each of the two doses of MMR separately or in combination.

The clinical aims are to determine whether a modified schedule of MMR administration reduces both the risk and severity of: (i) infections with unrelated pathogens and (ii) atopic and allergic diseases.

The laboratory aims are to: (i) quantify and characterise the immunological non-specific effects of MMR, and (ii) identify the biological pathways and molecular mechanisms that are altered by MMR vaccination.

Вмешательства

  • Биопрепарат Measles-Mumps-Rubella vaccine (MMR)
    0.5 ml of MMR vaccine injected intramuscularly in the deltoid region or in the anterolateral area of the thigh

Первичные конечные точки

  • Incidence of respiratory infection within the 3 months following randomisation [Срок оценки: Measured over the 3 months following randomisation]
Вторичные конечные точки (12)
  • Infection: Time to first infection within the 3 months following randomisation [Срок оценки: Measured over the 3 months following randomisation]
  • Infection: Time to first infection within the 18 months following randomisation [Срок оценки: Measured over the 18 months following randomisation]
  • Infection: Prevalence of infection within the 3 months following randomisation [Срок оценки: Measured over the 3 months following randomisation]
  • Infection: Prevalence of infection within the 18 months following randomisation [Срок оценки: Measured over the 18 months following randomisation]
  • Infection: Incidence of infection within the 3 months following randomisation [Срок оценки: Measured over the 3 months following randomisation]
  • Infection: Incidence of infection within the 18 months following randomisation [Срок оценки: Measured over the 18 months following randomisation]
  • Infection: Number of days free of infection within the 3 months following randomisation [Срок оценки: Measured over the 3 months following randomisation]
  • Infection: Number of days free of infection within the 18 months following randomisation [Срок оценки: Measured over the 18 months following randomisation]
  • Infection severity: Duration of infection within the 3 months following randomisation [Срок оценки: Measured over the 3 months following randomisation]
  • Infection severity: Duration of infection within the 18 months following randomisation [Срок оценки: Measured over the 18 months following randomisation]
  • Infection severity: Antibiotic use for infection within the 3 months following randomisation [Срок оценки: Measured over the 3 months following randomisation]
  • Infection severity: Antibiotic use for infection within the 18 months following randomisation [Срок оценки: Measured over the 18 months following randomisation]

Критерии участия

Критерии включения

  • Informed Consent as documented by signature
  • 6-month-old children
  • In overall good health, without any clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.) and no clinically significant abnormal finding on history and/or physical examination
  • Fully immunised for age according to the Swiss vaccination schedule
  • with at least 2 doses of DTP-containing vaccine
  • the last dose of vaccine received at least 2 weeks prior to enrolment

Критерии исключения

  • Contra-indications to MMR, including
  • immunosuppression (i.e. proven, suspected, or planned)
  • allergy to a component of the vaccine
  • receipt of a live-attenuated vaccine in the four weeks prior to inclusion
  • Vaccine refusal
  • Indication for an early MMR vaccination, including
  • Measles outbreak
  • Planned immunosuppression (indication to an accelerated schedule to be completed before starting an immunosuppressive treatment)
  • Travel to a region with a high risk of measles outbreak
  • Indication for vaccination with MMR-varicella (MMRV) instead of MMR, including
  • severe eczema
  • parental will
  • Parental inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, known/suspected non-compliance, substance abuse, etc.
  • Plan to move out of the country or have prolong absence during the trial
  • Other sibling included in the trial (in the case of multiple pregnancy, only one child can be randomised)
  • Any temporary contra-indication to MMR, including child being sick (active significant illness, inclusion can be delayed a few days until the illness resolves)

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Факторный дизайн
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Швейцария · 1 центр
  • University Hospitals of Geneva — Geneva

Идентификаторы

NCT: NCT05758532 · 2022-00616 · Ambizione n° PZ00P3_209050 · STARTER-MD n° RS08-08 · PRD n° 4-2022-I

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗