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
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 65
Maximum Age: 85
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
GSK Investigational Site
RECRUITING
San Diego
Florida
GSK Investigational Site
RECRUITING
Miami
Contact Information
Primary
US GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
877-379-3718
Backup
EU GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
+44 (0) 20 89904466
Time Frame
Start Date:2026-03-09
Estimated Completion Date:2027-06-03
Participants
Target number of participants:225
Treatments
Experimental: FLU/COVm_Dose Level 1
Participants receive a single intramuscular administration of the investigational mRNA Seasonal Flu/COVID-19 combination vaccine at dose level 1 (Lowest dose).
Experimental: FLU/COVm_Dose Level 2
Participants receive a single intramuscular administration of the investigational mRNA Seasonal Flu/COVID-19 combination vaccine at dose level 2 (Medium dose).
Experimental: FLU/COVm_Dose Level 3
Participants receive a single intramuscular administration of the investigational mRNA Seasonal Flu/COVID-19 combination vaccine at dose level 3 (Highest dose).
Active_comparator: Licensed Seasonal Influenza Vaccine Group
Participants receive a single intramuscular administration of a licensed seasonal Flu vaccine.
Active_comparator: Licensed COVID-19 Vaccine Group
Participants receive a single intramuscular administration of a licensed COVID-19 vaccine.