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

Official title

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

Overview

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.

Interventions

• Biological 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.
• Biological Licensed Seasonal Influenza Vaccine
  License Seasonal Influenza Vaccine will be administered as a single intramuscular dose.
• Biological Licensed COVID-19 Vaccine
  Licensed COVID-19 Vaccine will be administered as a single intramuscular dose.

Primary outcome measures

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

Secondary outcome measures (10)

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

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Sequential

Masking

Triple blind

Primary purpose

Prevention

Study locations

United States · 12 centers

• 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
• … and 4 more centers

Identifiers

NCT: NCT07464314 · 300768

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗