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Идёт набор NCT07543380

A Study to Learn Safety and Immune Response to Study Vaccine -RSVpreF in Adults at High Risk of Severe RSV Disease.

Фаза III С лечением Respiratory Syncytial Virus (RSV)

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: RSVpreF.
Кому может быть актуально
Состояния в реестре: Respiratory Syncytial Virus (RSV). Базовые параметры: 18 лет — 59 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
Япония
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

A PHASE 3, MULTICENTER, SINGLE-ARM, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN ADULTS CONSIDERED AT HIGH RISK OF SEVERE RSV DISEASE IN JAPAN

Обзор

The purpose of the study is to learn about the immune response after a RSVpreF vaccination. This study is being conducted in Japan. RSV is a common virus that can cause infections of the lungs and airways. The study is seeking participants who are: * 18 to 59 years of age * adults with health condition(s) that can put them at an increased risk of severe RSV disease It will also learn about the safety of RSVpreF vaccination. The study lasts about 2 months. Adults need to visit the research site at least 2 times. The participant will receive a phone call 2 months after vaccination for health checks.

Подробное описание

This is a Phase 3, multicenter, single-arm, open-label study that will assess the safety, tolerability, and immunogenicity of Pfizer's RSVpreF in adults 18 to 59 years of age considered to be at high risk of RSV disease due to certain chronic medical conditions in Japan.

Approximately 130 participants 18 to 59 years of age considered at high risk of RSV disease due to certain chronic medical conditions will be enrolled to receive RSVpreF.

The total duration of trial participation for each participant will be 2 months.

After screening and confirmation of eligibility, a prevaccination blood sample will be collected for immunogenicity assessments and a single dose of study intervention (RSVpreF) will be administered.

Participants will report daily reactogenicity data using an electronic device for 7-days or until resolution.

Participants will return approximately 1 month later for a follow-up blood draw for immunogenicity assessments and collection of safety information.

A telephone follow-up visit will be conducted approximately 2 months after vaccination to collect safety information.

Вмешательства

  • Биопрепарат RSVpreF
    RSV Vaccine

Первичные конечные точки

  • Percentage of participants reporting prompted local reactions within 7 days following investigational product administration [Срок оценки: Day 7]
  • Percentage of participants reporting prompted systemic events within 7 days following investigational product administration [Срок оценки: Day 7]
  • Percentage of participants reporting adverse events (AEs) through 1 month following investigational product administration [Срок оценки: 1 month after vaccination]
  • Percentage of participants reporting serious adverse events (SAEs) throughout the study [Срок оценки: 2 months after vaccination]
  • Geometric Mean Titer (GMT) ratio (GMR) , estimated by the ratio of the GMTs for RSV subgroup A (RSV A) and RSV subgroup B (RSV B) neutralizing titers (NTs) with RSVpreF in this study's participants to that in Study C3671013 Japanese older adults [Срок оценки: 1 month after vaccination]
Вторичные конечные точки (3)
  • GMT of NTs for RSV A and RSV B [Срок оценки: 1 month after vaccination]
  • Geometric mean fold rise (GMFR) of NTs for RSV A and RSV B [Срок оценки: 1 month after vaccination]
  • Seroresponse rate of NTs for RSV A and RSV B [Срок оценки: 1 month after vaccination]

Критерии участия

Критерии включения

  • Underlying health condition(s) that can put the participant at an increased risk of severe RSV/complications including chronic lung , heart, kidney, liver, nervous system, blood, or metabolic diseases

Критерии исключения

  • Received any kind of RSV vaccine before participating in this study
  • Determined as not eligible by the investigator based on the participant's past and present health condition(s), medication(s) and treatment(s)

Please refer to the study contact for further eligibility details.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

Япония · 5 центров
  • Tsuchiura Beryl Clinic — Tsuchiura
  • Nihonbashi Sakura Clinic — Chuo-ku
  • Tokyo-Eki Center-building Clinic — Chuo-ku
  • Fukuwa Clinic — Chuo-ku
  • Tenjin Sogo Clinic — Fukuoka

Идентификаторы

NCT: NCT07543380 · C3671060

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗