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Набор скоро начнётся NCT07224477

A Clinical Study of V540A in Healthy Female Participants (V540A-005)

Фаза II С лечением Healthy

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: V540A-2, V540A-3, GARDASIL®9.
Кому может быть актуально
Состояния в реестре: Healthy. Базовые параметры: 16 лет — 26 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
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 2, Randomized, Double-Blind, Comparator-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V540A in Healthy Females 16 to 26 Years of Age

Обзор

Researchers are looking for new ways to prevent cancers related to human papillomavirus (HPV). HPV is a common virus that can cause an infection. There are many different types of HPV. A standard vaccine to prevent HPV-related cancers is V503. V503 protects against 9 types of HPV. V540A is a study vaccine designed to protect against the same (shared) 9 HPV types plus other (unique) HPV types. Researchers want to learn if V540A: * Is safe and if people tolerate it * Works as well as V503 to cause an immune response (the body's response to protect against infections and illnesses) to the shared HPV types.

Вмешательства

  • Биопрепарат V540A-2
    Suspension administered via intramuscular (IM) injection.
  • Биопрепарат V540A-3
    Suspension administered via intramuscular (IM) injection.
  • Биопрепарат GARDASIL®9
    Suspension administered via IM injection.

Первичные конечные точки

  • Number of Participants Who Experience ≥1 Solicited Injection-site Adverse Event (AE) [Срок оценки: Up to approximately 7 months]
  • Number of Participants Who Experience ≥1 Solicited Pyrexia AE [Срок оценки: Up to approximately 7 months]
  • Number of Participants Who Experience ≥1 Vaccine-related Serious AE (SAE) [Срок оценки: Up to approximately 7 months]
  • Geometric Mean Titers (GMTs) to Each of the Shared Human Papillomavirus (HPV) Vaccine Types at Day 29 Postdose 3 [Срок оценки: Up to approximately 7 months]
Вторичные конечные точки (6)
  • GMTs of Each of the Shared and Unique HPV Vaccine Types at Day 29 Postdose 1 [Срок оценки: Up to 29 days]
  • GMTs of Each of the Shared and Unique HPV Vaccine Types at Day 29 Postdose 2 [Срок оценки: Up to approximately 3 months]
  • GMTs to Each of the Shared and Unique HPV Vaccine Types at Day 29 Postdose 3 [Срок оценки: Up to approximately 7 months]
  • Percentage of Participants with Seroconversion to Each of the Shared and Unique HPV Vaccine Types at Day 29 Postdose 1 [Срок оценки: Up to approximately 2 months]
  • Percentage of Participants with Seroconversion to Each of the Shared and Unique HPV Vaccine Types at Day 29 Postdose 2 [Срок оценки: Up to approximately 3 months]
  • Percentage of Participants with Seroconversion to Each of the Shared and Unique HPV Vaccine Types at Day 29 Postdose 3 [Срок оценки: Up to approximately 7 months]

Критерии участия

Критерии включения

The main inclusion criteria include but are not limited to the following:

  • Is in good health
  • Has a lifetime history of 0 to 4 sexual partners of any sex/gender
  • A participant assigned female sex at birth is eligible to participate if not breastfeeding during the study intervention period and for at least 30 days after the last dose of study intervention

Критерии исключения

The main exclusion criteria include but are not limited to the following:

  • Has a history of severe allergic reaction (e.g., swelling of the mouth and throat, difficulty breathing, hypotension, or shock) that required medical intervention
  • Has known or history of functional or anatomic asplenia
  • Is currently immunocompromised or has been diagnosed as having congenital or acquired immunodeficiency, human immunodeficiency virus infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition
  • Has thrombocytopenia or other coagulation disorder
  • Has had a positive test for human papillomavirus (HPV)
  • Has a history of recurrent respiratory papillomatosis or HPV-related head and neck cancer, or HPV-related anal lesions or anal cancer
  • Has a history of an abnormal cervical biopsy result
  • Has a history of HPV-related external genital lesions or external genital cancer, HPV-related vaginal lesions or vaginal cancer
  • Has received a dose of any HPV vaccine before study entry
  • Has received within 12 months before the Day 1 vaccination, is receiving, or plans to receive during the study, immunosuppressive therapies or other therapy known to interfere with the immune response
  • Is currently receiving systemic steroid therapy or has received 2 or more courses of high-dose corticosteroids lasting at least 1 week in duration in the year prior to Day 1 vaccination
  • Has received within the 3 months before the Day 1 vaccination, is receiving, or plans to receive during the study any immune globulin product

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07224477 · V540A-005 · U1111-1314-2250 · 2024-518805-16-00

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗