Идёт набор NCT07013487
A Study to Evaluate V181 Dengue Vaccine in Healthy Participants 2 to 17 Years of Age (V181-005/MOBILIZE-1)
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: V181, Placebo.
- Кому может быть актуально
- Состояния в реестре: Healthy. Базовые параметры: 2 лет — 17 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
- Индонезия, Малайзия, Филиппины, Пуэрто-Рико, Сингапур +2
- 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, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Immunogenicity, and Efficacy of V181 Dengue Vaccine in Healthy Participants 2 to 17 Years of Age
Обзор
The purpose of this study is to demonstrate that V181 is safe and well tolerated, elicits an immune response, and reduces the frequency of virologically confirmed dengue (VCD) of any severity, due to any of the 4 dengue serotypes, regardless of dengue serostatus at baseline in children 2 to 17 years of age.
Подробное описание
The Reactogenicity and Immunogenicity Subset consists of approximately 3600 participants who will be followed for immunogenicity and safety through 28 days postvaccination. The Long-term Immunogenicity Subset consists of approximately 620 participants randomly selected from the Reactogenicity and Immunogenicity Subset and will evaluate virus reduction neutralization test (VRNT) at designated timepoints up to 5 years postvaccination.
Вмешательства
- Биопрепарат V181
Participants will receive a single 0.5 mL SC dose of V181 on Day 1. - Биопрепарат Placebo
Participants will receive a single 0.5 mL SC dose of placebo on Day 1.
Первичные конечные точки
- Percentage of Participants Experiencing a Medically Attended Adverse Event (MAAE) [Срок оценки: Up to approximately 6 months postvaccination]
- Percentage of Participants Experiencing a Serious Adverse Event (SAE) [Срок оценки: Up to approximately 5 years postvaccination]
- Reactogenicity and Immunogenicity Subset: Percentage of Participants Experiencing Solicited Injection-site AEs [Срок оценки: Up to approximately 5 days postvaccination]
- Reactogenicity and Immunogenicity Subset: Percentage of Participants Experiencing Solicited Systemic AEs [Срок оценки: Up to approximately 28 days postvaccination]
- Percentage of Participants Experiencing Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD of Any Severity, Due to Any of the 4 Dengue Serotypes, Regardless of Dengue Serostatus at Baseline [Срок оценки: Up to approximately 3 years postvaccination]
Вторичные конечные точки (12)
- Percentage of Participants Experiencing Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD of Any Severity, Due to Each of the 4 Dengue Serotypes, Regardless of Dengue Serostatus at Baseline [Срок оценки: Up to approximately 3 years postvaccination]
- Percentage of Participants Experiencing Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD of Any Severity, by Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination [Срок оценки: Up to approximately 3 years postvaccination]
- Percentage of Participants Experiencing Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD of Any Severity, by Dengue Serostatus at Baseline, Up to Approximately 5 Years Postvaccination [Срок оценки: Up to approximately 5 years postvaccination]
- Percentage of Participants Experiencing Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD of Any Severity, Regardless of Dengue Serostatus at Baseline [Срок оценки: Up to approximately 5 years postvaccination]
- Percentage of Participants Experiencing Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD Meeting Criteria for Warning Signs or Severe Dengue, Regardless of Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination [Срок оценки: Up to approximately 3 years postvaccination]
- Percentage of Participants Experiencing Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD Meeting Criteria for Warning Signs or Severe Dengue, by Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination [Срок оценки: Up to approximately 3 years postvaccination]
- Percentage of Participants Experiencing Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD Meeting Criteria for Warning Signs or Severe Dengue, Regardless of Dengue Serostatus at Baseline, Up to Approximately 5 Years Postvaccination [Срок оценки: Up to approximately 5 years postvaccination]
- Percentage of Participants Experiencing Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD Meeting Criteria for Warning Signs or Severe Dengue, by Dengue Serostatus at Baseline, Up to Approximately 5 Years Postvaccination [Срок оценки: Up to approximately 5 years postvaccination]
- Percentage of Participants Experiencing Hospitalization Resulting from Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD of Any Severity, Regardless of Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination [Срок оценки: Up to approximately 3 years postvaccination]
- Percentage of Participants Experiencing Hospitalization Resulting from Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD of Any Severity, by Dengue Serostatus at Baseline, Up to Approximately 3 Years Postvaccination [Срок оценки: Up to approximately 3 years postvaccination]
- Percentage of Participants Experiencing Hospitalization Resulting from Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD of Any Severity, Regardless of Dengue Serostatus at Baseline, Up to Approximately 5 Years Postvaccination [Срок оценки: Up to approximately 5 years postvaccination]
- Percentage of Participants Experiencing Hospitalization Resulting from Symptomatic (Requiring Fever on at Least 2 of 3 Consecutive Days) VCD of Any Severity, by Dengue Serostatus at Baseline, Up to Approximately 5 Years Postvaccination [Срок оценки: Up to approximately 5 years postvaccination]
Критерии участия
The key Inclusion Criteria include but are not limited to:
- Is generally healthy based on medical history and physical examination.
The key Exclusion Criteria include but are not limited to:
- Has a known or suspected impairment of immunological function.
- Has a history of congenital or acquired immunodeficiency.
- Has a documented human immunodeficiency virus (HIV) infection or is breastfeeding from a mother with documented HIV infection.
- Has a documented history of hepatitis B or C infection.
- Has a bleeding disorder contraindicating subcutaneous vaccination or repeated venipuncture.
- Has a serious or progressive disease, including but not limited to cancer, uncontrolled diabetes, severe cardiac, renal or hepatic insufficiency, or systemic autoimmune or neurologic disorders.
- Has a known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders.
- Previous receipt of a dengue vaccine or plans to receive any dengue vaccine (investigational or approved) for the duration of the study (other than the study vaccine).
- Received systemic corticosteroids <30 days before receipt of study intervention or is expected to require systemic corticosteroids ≤28 days after receipt of study intervention.
- Has received a blood transfusion or blood products, including immunoglobulins, ≤6 months before receipt of study intervention or plans to receive a blood transfusion or blood products (including immunoglobulins) ≤28 days after receipt of study intervention.
- Has received immunosuppressive therapies, including chemotherapeutic agents used to treat cancer or other conditions, treatments associated with organ or bone marrow transplantation, or autoimmune disease, ≤6 months before receipt of study intervention or plans to receive immunosuppressive therapies ≤28 days after receipt of study intervention.
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
- Двойное слепое
- Основная цель
- Профилактика
Центры проведения
Таиланд · 10 центров
- Chulalongkorn University-Pediatrics ( Site 0063) — Bangkok
- Faculty of Tropical Medicine, Mahidol University ( Site 0062) — Bangkok
- Queen Sirikit National Institute of Child Health-Pediatric Infectious Disease ( Site 0071) — Bangkok
- Faculty of Medicine Siriraj Hospital-Pediatric Infectious Diseases ( Site 0065) — Bangkok
- Faculty of Tropical Medicine, Mahidol University - Vaccine Trial Centre ( Site 0067) — Ratchathewi
- Kamphaeng Phet-AFRIMS Virology Research Unit KAVRU ( Site 0070) — Muang
- Faculty of Medicine - Khon Kaen University-Pediatrics ( Site 0064) — Amphoe Mueang
- Thammasat University Hospital-Department of Pediatrics ( Site 0068) — Khong Luang
- … и ещё 2 центра
Малайзия · 7 центров
- Hospital Pakar Kanak - Kanak UKM (HPKK) ( Site 0024) — Cheras
- University Malaya Medical Centre-Department of Paediatrics ( Site 0025) — Lembah Pantai
- Hospital Sibu ( Site 0021) — Sibu
- Hospital Ampang ( Site 0028) — Ampang
- Hospital Al-Sultan Abdullah - Universiti Teknologi MARA ( Site 0029) — Bandar Puncak Alam
- Sunway Medical Centre ( Site 0027) — Petaling Jaya
- Hospital Tunku Azizah-Paediatric ( Site 0022) — Kuala Lumpur
Филиппины · 6 центров
- Health Index Multispecialty And Lying-In Clinic ( Site 0042) — Bacoor
- Chong Hua Hospital ( Site 0051) — Cebu City
- Norzel Medical and Diagnostic Clinic Foundation Corp ( Site 0044) — Cebu City
- West Visayas State University Medical Center ( Site 0045) — Iloilo City
- Philippine General Hospital ( Site 0041) — Manila
- University of the Philippines Manila ( Site 0047) — Metro Manila
Индонезия · 5 центров
- Jatinegara Primary Health Center ( Site 0102) — East Jakarta
- Cipayung Primary Health Center ( Site 0105) — East Jakarta
- Dr Cipto Mangunkusumo Hospital-Pediatrics ( Site 0101) — Jakarta
- Kelapa Gading Primary Health Center ( Site 0104) — North Jakarta
- Pasar Minggu Primary Health Center ( Site 0103) — South Jakarta
Пуэрто-Рико · 5 центров
- Clinical Research Investigator Group ( Site 0110) — Bayamón
- San Juan Bautista School of Medicine - Clinical Research Unit ( Site 0114) — Caguas
- Ponce Medical School Foundation Inc./CAIMED Center ( Site 0112) — Ponce
- Latin Clinical Trial Center ( Site 0113) — San Juan
- Wellness clinical Research Vega Baja ( Site 0116) — Vega Baja
Вьетнам · 5 центров
- Kien Giang Women's and Children hospital ( Site 0091) — Rach Gia
- Cai Lay Regional General Hospital ( Site 0093) — Cai Lậy
- Quang Nam Hospital for Women and Children ( Site 0094) — Da Nang
- Dong Thap General Hospital ( Site 0092) — Dong Thập
- Pasteur Institute in Ho Chi Minh city ( Site 0089) — Ho Chi Minh City
Сингапур · 3 центра
- National University Hospital-Paediatrics ( Site 0001) — Singapore
- KK Women's and Children's Hospital ( Site 0002) — Singapore
- Tan Tock Seng Hospital ( Site 0003) — Singapore
Идентификаторы
NCT: NCT07013487 · V181-005 · MOBILIZE-1 · 2022-003483-25