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Набира участници Фаза 3 NCT07013487

A Study to Evaluate V181 Dengue Vaccine in Healthy Participants 2 to 17 Years of Age (V181-005/MOBILIZE-1)

Фаза 3 – широко изпитване преди одобрение
Заболявания: Healthy

Спонсор: Merck Sharp & Dohme LLC

Налично на: БГ
Обобщение
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.
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.
Кой може да участва
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.
Интервенции
V181
BIOLOGICAL
Placebo
BIOLOGICAL
Места на провеждане 39
Indonesia (5)
Jatinegara Primary Health Center ( Site 0102)
East Jakarta , Jakarta Special Capital Region
Study Coordinator
Cipayung Primary Health Center ( Site 0105)
East Jakarta , Jakarta Special Capital Region
Study Coordinator
Dr Cipto Mangunkusumo Hospital-Pediatrics ( Site 0101)
Jakarta , Jakarta Special Capital Region
Study Coordinator
Kelapa Gading Primary Health Center ( Site 0104)
North Jakarta , Jakarta Special Capital Region
Study Coordinator
Pasar Minggu Primary Health Center ( Site 0103)
South Jakarta , Jakarta Special Capital Region
Study Coordinator
Malaysia (6)
Hospital Ampang ( Site 0028)
Ampang , Selangor
Study Coordinator
Hospital Al-Sultan Abdullah - Universiti Teknologi MARA ( Site 0029)
Bandar Puncak Alam , Selangor
COMPLETED
Hospital Tunku Azizah-Paediatric ( Site 0022)
Kuala Lumpur
Study Coordinator
University Malaya Medical Centre-Department of Paediatrics ( Site 0025)
Lembah Pantai , Kuala Lumpur
Study Coordinator
Sunway Medical Centre ( Site 0027)
Petaling Jaya , Selangor
Study Coordinator
Hospital Sibu ( Site 0021)
Sibu , Sarawak
Study Coordinator
Philippines (6)
Health Index Multispecialty And Lying-In Clinic ( Site 0042)
Bacoor , Cavite
Study Coordinator
Chong Hua Hospital ( Site 0051)
Cebu City , Cebu
Study Coordinator
Norzel Medical and Diagnostic Clinic Foundation Corp ( Site 0044)
Cebu City , Central Visayas (Region VII)
Study Coordinator
West Visayas State University Medical Center ( Site 0045)
Iloilo City , Iloilo
ACTIVE_NOT_RECRUITING
Philippine General Hospital ( Site 0041)
Manila , National Capital Region
Study Coordinator
University of the Philippines Manila ( Site 0047)
Metro Manila , National Capital Region
Study Coordinator
Puerto Rico (5)
Clinical Research Investigator Group ( Site 0110)
Bayamón
Study Coordinator
San Juan Bautista School of Medicine - Clinical Research Unit ( Site 0114)
Caguas
Study Coordinator
Ponce Medical School Foundation Inc./CAIMED Center ( Site 0112)
Ponce
Study Coordinator
Latin Clinical Trial Center ( Site 0113)
San Juan
Study Coordinator
Wellness clinical Research Vega Baja ( Site 0116)
Vega Baja
Study Coordinator
Сингапур (3)
National University Hospital-Paediatrics ( Site 0001)
Singapore , Central Singapore
Study Coordinator
KK Women's and Children's Hospital ( Site 0002)
Singapore , Central Singapore
Study Coordinator
Tan Tock Seng Hospital ( Site 0003)
Singapore , Central Singapore
Study Coordinator
Тайланд (9)
Faculty of Medicine - Khon Kaen University-Pediatrics ( Site 0064)
Amphoe Mueang , Changwat Khon Kaen
Study Coordinator
Chulalongkorn University-Pediatrics ( Site 0063)
Bangkok , Bangkok
Study Coordinator
Faculty of Tropical Medicine, Mahidol University ( Site 0062)
Bangkok , Bangkok
Study Coordinator
Queen Sirikit National Institute of Child Health-Pediatric Infectious Disease ( Site 0071)
Bangkok , Bangkok
Study Coordinator
Faculty of Medicine Siriraj Hospital-Pediatric Infectious Diseases ( Site 0065)
Bangkok , Bangkok
ACTIVE_NOT_RECRUITING
Maharaj Nakorn Chiang Mai Hospital ( Site 0066)
Chiang Mai
Study Coordinator
Songklanagarind hospital-Department of Pediatrics ( Site 0061)
Hat Yai , Changwat Songkhla
Study Coordinator
Thammasat University Hospital-Department of Pediatrics ( Site 0068)
Khong Luang , Changwat Pathum Thani
Study Coordinator
Faculty of Tropical Medicine, Mahidol University - Vaccine Trial Centre ( Site 0067)
Ratchathewi , Bangkok
Study Coordinator
Vietnam (5)
Cai Lay Regional General Hospital ( Site 0093)
Cai Lậy , Tien Giang
Study Coordinator
Quang Nam Hospital for Women and Children ( Site 0094)
Da Nang
Study Coordinator
Dong Thap General Hospital ( Site 0092)
Dong Thập
Study Coordinator
Pasteur Institute in Ho Chi Minh city ( Site 0089)
Ho Chi Minh City
Study Coordinator
Kien Giang Women's and Children hospital ( Site 0091)
Rach Gia , An Giang
Study Coordinator
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
2 Years
Максимална възраст
17 Years
Здрави доброволци
Не
Начална дата
11.06.2025
Крайна дата
24.10.2031
Регистрационен номер
NCT07013487
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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