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Safety, Tolerability, and Immunogenicity of VAX-31 in Adults ≥50 Years With Immunobridging to Adults 18-49
Sponsor: Vaxcyte, Inc.
Summary
The primary objectives of this study are to evaluate the safety, tolerability, immunologic noninferiority (for shared serotypes) and immunologic superiority (for novel serotypes) of VAX-31 compared to PCV21 and PCV20 in adults ≥50 years of age, and to bridge the immune responses induced by VAX-31 in adults 50-64 years of age to adults 18-49 years of age.
Official title: A Phase 3, Randomized, Double-Blind, Active-Controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 in Healthy Subjects 50 Years of Age and Older With Immunobridging to Subjects 18-49 Years of Age
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
4049
Start Date
2025-12-01
Completion Date
2027-01
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
PCV20
0.5 mL of the 20 valent pneumococcal conjugate vaccine will be administered into the deltoid muscle
PCV21
0.5 mL of the 21 valent pneumococcal conjugate vaccine will be administered into the deltoid muscle
Locations (30)
Accel Research Site - Achieve - Birmingham - ERN
Birmingham, Alabama, United States
Center for Indigenous Health - Chinle - Johns Hopkins Project
Chinle, Arizona, United States
Center for Indigineous Health - Whiteriver - John Hopkins Project
Whiteriver, Arizona, United States
Clinical Innovations Trials - Riverside - CenExel
Riverside, California, United States
Research Centers of America - Hollywood - CenExel
Hollywood, Florida, United States
Health Awareness - Jupiter - ERN
Jupiter, Florida, United States
Suncoast Research Group LLC
Miami, Florida, United States
Precision Clinical Research - Sunrise
Sunrise, Florida, United States
Clinical Research Atlanta - Headlands
Stockbridge, Georgia, United States
Velocity Clinical Research - Valparaiso (Buynak Clinical Research)
Valparaiso, Indiana, United States
Johnson County Clin-Trials - JCCT
Lenexa, Kansas, United States
Alliance for Multispecialty Research, LLC - West Wichita
Wichita, Kansas, United States
DelRicht Clinical Research, LLC - New Orleans
New Orleans, Louisiana, United States
Headlands Research - Detroit - Headlands
Southfield, Michigan, United States
DelRicht Research, LLC - Gulfport
Gulfport, Mississippi, United States
Sky Integrative Medical Center - SKYCRNG
Ridgeland, Mississippi, United States
Alliance for Multispecialty Research, LLC - Kansas City
Kansas City, Missouri, United States
Velocity Clinical Research
Omaha, Nebraska, United States
Advanced Memory Research Institute - CenExe
Toms River, New Jersey, United States
Center for Indigineous Health - Gallup - John Hopkins Project
Gallup, New Mexico, United States
Center for Indigineous Health - Shiprock - John Hopkins Project
Shiprock, New Mexico, United States
Rochester Clinical Research - ATLAS - Rochester
Rochester, New York, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
Lynn Institute of Norman
Norman, Oklahoma, United States
DM Clinical Research - Philadelphia
Philadelphia, Pennsylvania, United States
Coastal Carolina Research Center - Alcanza - HyperCore
North Charleston, South Carolina, United States
Flourish Research - San Antonio
San Antonio, Texas, United States
DM Clinical Research - Sugarland
Sugar Land, Texas, United States
JBR Clinical Research - CenExel JBR
Salt Lake City, Utah, United States
Charlottesville Medical Research Center - Alcanza - HyperCore
Charlottesville, Virginia, United States