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
GlaxoSmithKline
Summary
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.
Eligibility
- Age range
- 65–85 years
- Sex
- All
- Healthy volunteers
- No
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 significa…
Interventions
- BiologicalInvestigational 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.
- BiologicalLicensed Seasonal Influenza Vaccine
License Seasonal Influenza Vaccine will be administered as a single intramuscular dose.
- BiologicalLicensed COVID-19 Vaccine
Licensed COVID-19 Vaccine will be administered as a single intramuscular dose.
Locations (2)
- GSK Investigational SiteSan Diego, California
- GSK Investigational SiteMiami, Florida