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Safety, Tolerability, and Immunogenicity Study of a 31-Valent Pneumococcal Conjugate Vaccine (VAX-31) in Adults

NCT06151288 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 1015

Last updated 2025-07-28

Study results available
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Summary

The objective of the study is to evaluate the safety, tolerability and immunogenicity of a single injection of VAX-31 at 3 dose levels compared to Prevnar 20™ (PCV20) in adults 50 to 64 years of age in Stage 1. Stage 2 will evaluate the safety, tolerability, and immunogenicity of a single injection of VAX-31 at 3 dose levels compared to PCV20 in adults aged 50 years and older.

Conditions

  • Pneumococcal Vaccines

Interventions

BIOLOGICAL

31 valent pneumococcal conjugate vaccine

0.5 ml dose of VAX-31 was administered into the deltoid muscle at Day 1

BIOLOGICAL

20 valent pneumococcal conjugate vaccine

0.5 ml dose of PCV20 was administered into the deltoid muscle at Day 1

Sponsors & Collaborators

  • Vaxcyte, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Development · Vaxcyte, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-08
Primary Completion
2024-07-17
Completion
2024-07-17
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 NCT06151288 on ClinicalTrials.gov