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

NCT07284654 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4049

Last updated 2026-05-15

No results posted yet for this study

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.

Conditions

  • Pneumococcal Vaccines

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

Sponsors & Collaborators

  • Vaxcyte, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2027-01-31
Completion
2027-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07284654 on ClinicalTrials.gov