A Study of mRNA-1018-H5 Pandemic Influenza Vaccine in Healthy Adults

Официальное название

A Phase 3, Randomized, Observer-blind, Placebo-controlled Study to Evaluate the Immunogenicity, Safety, and Reactogenicity of mRNA-1018-H5 Pandemic Influenza Vaccine in Adults ≥18 Years of Age

Обзор

The purpose of this study is to evaluate humoral immunogenicity after 2 doses of mRNA-1018-H5, and to evaluate the safety and reactogenicity of mRNA-1018-H5 in adults ≥18 years of age.

Вмешательства

• Биопрепарат mRNA-1018-H5
  Sterile liquid for injection.
• Биопрепарат Placebo
  Sterile liquid for injection.

Первичные конечные точки

• Percentage of Participants With Hemagglutination Inhibition (HAI) Titer ≥ 1:40 at Day 43 [Срок оценки: Day 43]
• Percentage of Participants With Seroconversion at Day 43, as Measured by HAI Assay [Срок оценки: Day 43]
• Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) [Срок оценки: Up to Day 29 (7 days after each injection)]
• Number of Participants with Unsolicited Adverse Events (AEs) [Срок оценки: Up to Day 50 (28 days after each injection)]
• Number of Participants with AEs Leading to Discontinuation, Medically-attended AEs (MAAEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) [Срок оценки: Day 1 to Day 205]

Вторичные конечные точки (4)

• Geometric Mean Titer (GMT) of Anti-H5N1 Antibodies at Day 43, as Measured by Microneutralization (MN) Assay [Срок оценки: Day 43]
• GMT of HAI Antibodies at Days 22 and 205, as Measured by HAI Assay [Срок оценки: Days 22 and 205]
• GMT of HAI Antibodies at Days 22 and 205, as Measured by MN Assay [Срок оценки: Days 22 and 205]
• Percentage of Participants with HAI Titers at Different Cut-Offs [Срок оценки: Up to Day 205]

Критерии участия

Критерии включения

• Healthy as determined by medical evaluation including medical history; and physical examination. Participants with clinically stable chronic medical conditions are permitted.
• Participants who are assigned female at birth or could become pregnant are eligible to participate if the participant is not pregnant or breast/chest feeding, and one of the following conditions applies:

• Is a person of nonchildbearing potential (PONCBP) OR
• Is a person of childbearing potential (POCBP)
• A POCBP must have a negative highly sensitive pregnancy test at Screening and on the day of the first dose of study intervention.

Критерии исключения

• Participant is acutely ill or febrile (body temperature ≥ 38.0 degrees Celsius \[°C\]/100.4 degrees Fahrenheit \[°F\]) within 72 hours prior to or at the Screening Visit or Day 1.
• History of myocarditis, pericarditis, or myopericarditis.
• History of Guillain-Barre syndrome.
• Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infections disease.
• Treated with antiviral therapies for influenza (eg, Tamiflu, Xofluza) within 28 days prior to Day 1.
• Prior receipt of a pandemic influenza vaccine or participation in any pandemic influenza vaccine clinical study, including the mRNA-1018-P101 study.
• Any medical, psychiatric, or occupational condition, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with adherence to study procedures or the interpretation of study results.
• Participant has received systemic immunosuppressants including long-acting biological therapies that affect immune responses (eg, infliximab, methotrexate, omalizumab, etc.), within 180 days prior to Screening or plans to do so at any time during participation in the study.
• Participant has received corticosteroids at ≥10 mg/day of prednisone or equivalent for >14 days in total within 90 days prior to Day 1 (Baseline) or is anticipating the need for corticosteroids at any time during the study.
• Participants has received any licensed vaccine authorized or approved by local health agency including mRNA vaccine ≤28 days prior to study intervention (Day 1) or plans to receive a vaccine authorized or approved by local health agency within 21 days after the study intervention.
• Participant has participated in an interventional clinical study within 90 days prior to the Screening visit based on the medical history interview or plans to do so while participating in this study.

Note: Other inclusion/exclusion criteria may apply.

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

Великобритания · 26 центров

• Velocity Clinical Research-Bristol — Bristol
• Velocity Clinical Research - High Wycombe — High Wycombe
• Wansford Research Ltd — Peterborough
• Futuremeds Teesside Middlefield Centre University Hospital of North Tees — Stockton-on-Tees
• NIHR Wessex CRDC - Bournemouth Research Hub (Under University Hospital Southampton NHS Fou — Bournemouth
• NIHR Wessex CRDC - Weymouth Research Hub (Under University Hospital Southampton NHS Founda — Weymouth
• Panthera Glasgow — Glasgow
• Panthera Enfield — Enfield
• … и ещё 18 центров

США · 10 центров

• Velocity Clinical Research, San Bernardino — San Bernardino
• Velocity Clinical Research, Savannah — Savannah
• Velocity Clinical Research, Boise — Meridian
• Velocity Clinical Research, Rockville — Rockville
• Velocity Clinical Research, Omaha — Omaha
• Velocity Clinical Research, Cleveland — Beachwood
• Velocity Clinical Research, Providence — East Greenwich
• Velocity Clinical Research, Anderson — Anderson
• … и ещё 2 центра

Идентификаторы

NCT: NCT07496450 · mRNA-1018-P301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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