A Phase 3 Study in India to Describe the Safety and Immunogenicity of RSVpreF

Официальное название

A PHASE 3 STUDY IN INDIA TO DESCRIBE THE SAFETY AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN ADULTS

Обзор

The purpose of this phase 3 multicenter, double-blinded, placebo-controlled study in India is to learn about the safety and immunogenicity of RSVpreF in adults.

Вмешательства

• Биопрепарат RSVpreF
  RSVpreF Vaccine
• Биопрепарат Placebo
  Placebo

Первичные конечные точки

• Proportion of participants reporting local reactions within 7 days following investigational product administration [Срок оценки: Within 7 days]
• Percentage of participants reporting systemic events within 7 days following investigational product administration [Срок оценки: Within 7 days]
• 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: 3 months after vaccination]
• Neutralizing Titers (NTs) for RSV A and RSV B expressed as Geometric Mean Titers (GMT) [Срок оценки: Before vaccination, 1 month after vaccination]
• NTs for RSV A and RSV B expressed as Geometric Mean Fold Rise (GMFR) [Срок оценки: Before vaccination, 1 month after vaccination]
• NTs for RSV A and RSV B expressed as seroresponse rate [Срок оценки: 1 month after vaccination]

Критерии участия

Критерии включения

• Participants ≥18 years of age at Visit 1.
• Participants who are ambulatory and live independently in the community.
• Participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
• Applicable to participants 18 through 59 years of age: Participants who are healthy or have stable preexisting diseases. These participants are considered at high risk of RSV disease by having at least 1 reportable stable chronic medical condition(s) that belongs to 1 or more of the following:
• Chronic heart disease (ie, coronary artery disease, heart failure, or congenital heart disease)
• Chronic lung disease (ie, COPD, emphysema, asthma, interstitial lung disease, or cystic fibrosis)
• Nongestational diabetes mellitus type 1 or type 2
• Severe obesity (body mass index \[BMI\] ≥40 kg/m2)
• Chronic liver disease (ie, cirrhosis)
• Chronic kidney disease (not including end-stage renal disease with or without dialysis)
• Chronic neurological disease that causes impaired airway clearance or respiratory muscle weakness (ie, poststroke dysphagia, amyotrophic lateral sclerosis, or muscular dystrophy)
• Chronic hematologic disease (ie, sickle cell disease or thalassemia)

Note: A chronic medical condition for this study is defined as:

• Duration ≥6 months.
• Requires regular medical follow-up or ongoing prescribed medication or hospitalization in the previous year.
• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in the protocol.

Критерии исключения

• Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s) or any related vaccine.
• Prior history of any subtype of Guillain-Barré syndrome of any etiology.
• Serious chronic disorder, including metastatic malignancy, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study.
• Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
• Individuals who receive chronic systemic treatment with immunosuppressive therapy, including cytotoxic agents, immunosuppressive monoclonal antibodies, systemic corticosteroids, or radiotherapy, eg, for cancer or an autoimmune disease, from 60 days before study intervention administration or planned receipt throughout the study.

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

Индия · 13 центров

• King George Hospital — Visakhapatnam
• BGS Global Institute of Medical Sciences (BGSGIMS) — Bangalore
• Radhakrishna Multispeciality Hospital and IVF Center — Bangalore
• Belagavi Institute of Medical Sciences - Belagavi — Belagavi
• Suyog Hospital — Nashik
• Aakash Healthcare Private Limited — Dwarka
• All India Institute Of Medical Sciences — New Delhi
• Sir Ganga Ram Hospital — New Delhi
• … и ещё 5 центров

Идентификаторы

NCT: NCT07653100 · C3671040

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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