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ACTIVE NOT RECRUITING
NCT07284654
PHASE3

Safety, Tolerability, and Immunogenicity of VAX-31 in Adults ≥50 Years With Immunobridging to Adults 18-49

Sponsor: Vaxcyte, Inc.

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

31 valent pneumococcal conjugate vaccine

0.5 mL of VAX-31 will be administered into the deltoid muscle

BIOLOGICAL

PCV20

0.5 mL of the 20 valent pneumococcal conjugate vaccine will be administered into the deltoid muscle

BIOLOGICAL

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