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Safety, Tolerability, and Immunogenicity Study of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Adults

NCT05266456 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 835

Last updated 2024-04-18

Study results available
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Summary

The objective of the study is to evaluate the safety and tolerability of a single injection of VAX-24 at 3 dose levels compared to Prevnar 20™ (PCV20) in adults 18 to 49 years of age in Phase 1. The Phase 2 will evaluate the safety, tolerability, and immunogenicity of a single injection of VAX-24 at 3 dose levels compared to PCV20 in adults aged 50 to 64 years of age in Phase 2.

Conditions

  • Pneumococcal Vaccines

Interventions

BIOLOGICAL

24 valent pneumococcal conjugate vaccine

0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1

BIOLOGICAL

20 valent pneumococcal conjugate vaccine

0.5 ml dose of PCV20 will be 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
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-22
Primary Completion
2023-01-10
Completion
2023-01-10
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 NCT05266456 on ClinicalTrials.gov