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ACTIVE NOT RECRUITING
NCT07365826
PHASE3

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.

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

31-valent pneumococcal conjugate vaccine

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

BIOLOGICAL

Seasonal Influenza Vaccine (SIV) (Flublok)

0.5 mL of SIV into the deltoid muscle

BIOLOGICAL

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