A Study on the Safety and Immune Response of Investigational mRNA Seasonal Flu/COVID-19 Combination Vaccine in Adults

Официальное название

A Phase 1, Observer-Blind, Randomized, Controlled Study to Evaluate the Safety and Immunogenicity of an Investigational mRNA Seasonal Flu/COVID-19 Combination Vaccine in Adults

Обзор

This early-stage study will look at a new mRNA vaccine that combines defenses against both seasonal flu and COVID-19 in terms of its safety and how it builds protection. Healthy adults aged 65 to 85 will receive different doses of this new vaccine, a standard flu vaccine, or COVID-19 vaccine. The study will assess any side effects or health issues, and additional blood samples will be collected at specific times to evaluate how well participants bodies build protection against the flu and COVID-19.

Вмешательства

• Биопрепарат Investigational mRNA Seasonal Flu/COVID-19 Combination (Flu/COVm) Vaccine
  Flu/COVm Vaccine with multiple dose levels (Dose Level 1, Dose Level 2, and Dose Level 3), will be administered via single intramuscular injection.
• Биопрепарат Licensed Seasonal Influenza Vaccine
  License Seasonal Influenza Vaccine will be administered as a single intramuscular dose.
• Биопрепарат Licensed COVID-19 Vaccine
  Licensed COVID-19 Vaccine will be administered as a single intramuscular dose.

Первичные конечные точки

• Number of Participants with an Increase in Toxicity Grade of Laboratory Value Abnormalities Following Administration of the Study Intervention [Срок оценки: Day 1 to Day 3]
• Number of Participants with an Increase in Toxicity Grade of Laboratory Value Abnormalities following Administration of Study Intervention [Срок оценки: Day 1 to Day 8]
• Number of Participants with an Increase in Toxicity Grade of Laboratory Value Abnormalities following Administration of Study Intervention [Срок оценки: Day 1 to Day 29]
• Number of Participants with Solicited Administration Site Adverse Events (AEs) [Срок оценки: Day 1 to Day 7]
• Number of Participants with Solicited Systemic AEs [Срок оценки: Day 1 to Day 7]
• Number of Participants with Unsolicited AEs [Срок оценки: Day 1 to Day 28]
• Number of Participants with Serious Adverse Events (SAEs) [Срок оценки: Day 1 to Day 181]
• Number of Participants with Adverse Events of Special Interest (AESIs) [Срок оценки: Day 1 to Day 181]
• Number of Participants with Medically Attended Adverse Events (MAAEs) [Срок оценки: Day 1 to Day 181]

Вторичные конечные точки (10)

• Geometric Mean Titer (GMT) Of Antigen 1 Titer [Срок оценки: At Day 29]
• Percentage of Participants with Antigen 1 Seroconversion Rate (SCR) [Срок оценки: Day 1 to Day 29]
• Percentage of Participants with Antigen 1 Seroprotection Rate (SPR) [Срок оценки: At Day 1 and Day 29]
• Geometric Mean Increase (GMI) of Antigen 1 Titer [Срок оценки: Day 1 to Day 29]
• GMT Of Antigen 2 Titer [Срок оценки: At Day 29]
• Percentage of Participants with Antigen 2 SCR [Срок оценки: Day 1 to Day 29]
• GMI of Antigen 2 Titer [Срок оценки: Day 1 to Day 29]
• GMT ratio of serum neutralization titers against pseudovirus bearing spike from SARS-CoV-2 vaccine matched variant(s) [Срок оценки: At Day 29]
• Percentage of participants with seroresponse of neutralization titers against pseudovirus bearing spike from SARS-CoV-2 vaccine matched variant(s) [Срок оценки: Day 1 to Day 29]
• GMI of neutralization titers against pseudovirus bearing spike from SARS-CoV-2 vaccine matched variant(s) [Срок оценки: Day 1 to Day 29]

Критерии участия

Критерии включения

• Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol independently or with the assistance of the caregiver.
• Informed consent obtained from the participant prior to performance of any study-specific procedure.
• A male or female 65 to 85 years of age (YoA) (inclusive) at the time of screening.
• Healthy participants or medically stable patients as established by medical history and clinical examination.
• Other protocol-defined inclusion criteria may apply.

Критерии исключения

• Any clinically significant laboratory abnormality.
• History of symptomatic influenza/ SARS-CoV-2 infection confirmed by local health authority-approved testing methods within 180 days (for influenza) or 90 days (SARS-CoV-2 infection) prior to study intervention administration.
• History of Guillain-Barré syndrome (GBS) within 6 weeks of receiving any vaccine.
• Current or past malignancy, unless completely resolved without clinically significant sequelae (e.g., no evidence of disease following successful treatment of basal cell carcinoma cases are allowed) for >5 years.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
• History of or current suspicion of myocarditis or pericarditis (including following administration of an mRNA vaccine); or idiopathic cardiomyopathy, or presence of any medical condition that increases the risk of myocarditis or pericarditis, including cocaine abuse, cardiomyopathy, endomyocardial fibrosis, hypereosinophilic syndrome, hypersensitivity myocarditis, eosinophilic granulomatosis with polyangiitis and persistent myocardial infection.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).
• Acute or unstable chronic conditions, clinically significant pulmonary, cardiovascular, or renal functional abnormality, as determined by physical examination and/or laboratory screening tests.
• History of hypersensitivity or allergic reaction to any previous influenza or COVID-19 vaccine.
• History of hypersensitivity or allergic reaction to any previous mRNA vaccine.
• Administration of any influenza vaccine within 181 days before the study intervention administration (Day -180 to Day 1) or planned administration within 28 days (Day 29) after the study intervention administration.
• Administration of a SARS-CoV-2 antigen-containing vaccine in the period starting 91 days before the study intervention administration (Day -90 to Day 1) or planned administration within 28 days (Day 29) after the study intervention administration.
• Administration of any mRNA-based vaccine in the period starting 29 days before the study intervention administration (Day -28 to Day 1) or planned administration within 28 days (Day 29) after the study intervention administration.
• Administration of any other vaccine not foreseen by the study protocol in the period starting 29 days (Day -28 to Day 1) before the study intervention administration or planned administration within 28 days (Day 29) after the study intervention administration.
• Other protocol-defined exclusion criteria may apply.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

США · 12 центров

• GSK Investigational Site — Anniston
• GSK Investigational Site — Little Rock
• GSK Investigational Site — Fair Oaks
• GSK Investigational Site — San Diego
• GSK Investigational Site — Miami
• GSK Investigational Site — Miami Lakes
• GSK Investigational Site — West Palm Beach
• GSK Investigational Site — Stockbridge
• … и ещё 4 центра

Идентификаторы

NCT: NCT07464314 · 300768

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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