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
Brief Summary

This early-stage study will look at a new mRNA vaccine that combines defenses againstboth 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 standardflu vaccine, or COVID-19 vaccine. The study will assess any side effects or healthissues, and additional blood samples will be collected at specific times to evaluate howwell participants bodies build protection against the flu and COVID-19.

Detailed Description

Not Provided

Recruiting
Influenza, Human+COVID-19

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.

Eligibility Criteria

Inclusion Criteria:

1. 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.

2. Informed consent obtained from the participant prior to performance of any
study-specific procedure.

3. A male or female 65 to 85 years of age (YoA) (inclusive) at the time of screening.

4. Healthy participants or medically stable patients as established by medical history
and clinical examination.

5. Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

1. Any clinically significant laboratory abnormality.

2. 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.

3. History of Guillain-Barré syndrome (GBS) within 6 weeks of receiving any vaccine.

4. 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.

5. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
medical history and physical examination (no laboratory testing required).

6. 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.

7. History of any reaction or hypersensitivity likely to be exacerbated by any
component of the study intervention(s).

8. Acute or unstable chronic conditions, clinically significant pulmonary,
cardiovascular, or renal functional abnormality, as determined by physical
examination and/or laboratory screening tests.

9. History of hypersensitivity or allergic reaction to any previous influenza or
COVID-19 vaccine.

10. History of hypersensitivity or allergic reaction to any previous mRNA vaccine.

11. 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.

12. 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.

13. 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.

14. 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.

15. Other protocol-defined exclusion criteria may apply.

Eligibility Gender
All
Eligibility Age
Minimum: 65 Years ~ Maximum: 85 Years
Countries
United States
Locations

GSK Investigational Site
San Diego, California, United States

GSK Investigational Site
Miami, Florida, United States

Contacts

US GSK Clinical Trials Call Center
877-379-3718
GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center
+44 (0) 20 89904466
GSKClinicalSupportHD@gsk.com

Not Provided

GlaxoSmithKline
NCT Number
Keywords
Influenza
Covid-19
SARS-CoV-2
mRNA Vaccine
Combination vaccine
Immunogenicity
older adults
MeSH Terms
Influenza, Human
COVID-19
Vaccines