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A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Sponsor: Vaxcyte, Inc.
Summary
This is a Phase 3, randomized, double-blind study to evaluate the safety and immunogenicity of VAX-31 and seasonal influenza vaccine in pneumococcal-naïve adults ≥ 50 years when the two vaccines are administered at the same visit or separately.
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 Concomitantly Administered With Seasonal Influenza Vaccine in Healthy Subjects 50 Years of Age and Older
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1390
Start Date
2026-01-12
Completion Date
2027-03
Last Updated
2026-03-31
Healthy Volunteers
Yes
Conditions
Interventions
31-valent pneumococcal conjugate vaccine
0.5 mL of VAX-31 will be administered into the deltoid muscle
Seasonal Influenza Vaccine (SIV) (Flublok)
0.5 mL of SIV into the deltoid muscle
Placebo
0.5mL of placebo (normal saline) into the deltoid muscle
Locations (25)
Hope Research Institute
Phoenix, Arizona, United States
Tekton Research at Fort Collins
Fort Collins, Colorado, United States
University Clinical Research - Deland
DeLand, Florida, United States
CenExel Research Centers of America
Hollywood, Florida, United States
Health Awareness
Jupiter, Florida, United States
Accel Research Sites - Lakeland
Lakeland, Florida, United States
Accel Research Sites - Largo
Largo, Florida, United States
Precision Clinical Research
Sunrise, Florida, United States
Velocity Valparaiso
Valparaiso, Indiana, United States
Johnson County ClinTrials
Lenexa, Kansas, United States
AMR Lexington
Lexington, Kentucky, United States
DM Clinical Research - Detroit
Detroit, Michigan, United States
Velocity Omaha
Omaha, Nebraska, United States
Rochester Clinical Research
Rochester, New York, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
Coastal Carolina Research Center
North Charleston, South Carolina, United States
DelRicht Research - Hendersonville
Hendersonville, Tennessee, United States
AMR Knxoville
Knoxville, Tennessee, United States
Tekton Research at Austin
Austin, Texas, United States
REX Clinical Trials
Beaumont, Texas, United States
Epic Medical Research
DeSoto, Texas, United States
CenExel JBR Clinical Research
Salt Lake City, Utah, United States
Charlottesville Medical Research Center
Charlottesville, Virginia, United States
Health Research of Hampton Roads, Inc.
Newport News, Virginia, United States
Clinical Research Partners, LLC.
Richmond, Virginia, United States