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

NCT05844423 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 802

Last updated 2025-09-11

No results posted yet for this study

Summary

The objective of the study is to evaluate the safety and tolerability of 4 injections of VAX-24 (at 3 dose levels) compared to PCV15 in infants at 2, 4, 6, and 12-15 months of age, in addition to receiving routine US concomitant vaccines. Stage 1 of the study will comprise 3 dose ascending cohorts. Stage 2 of the study will enroll the remainder of the sample size.

Conditions

  • Pneumococcal Vaccines

Interventions

BIOLOGICAL

0.5 ml dose of 1.1 mcg VAX-24

24 valent pneumococcal conjugate vaccine

BIOLOGICAL

0.5 ml dose of PCV20

20 valent pneumococcal conjugate vaccine

BIOLOGICAL

0.5 ml dose of 2.2 mcg VAX-24

24 valent pneumococcal conjugate vaccine

BIOLOGICAL

0.5 ml dose of 2.2/4.4 mcg VAX-24

24 valent pneumococcal conjugate vaccine

Sponsors & Collaborators

  • Vaxcyte, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
42 Days
Max Age
89 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-29
Primary Completion
2025-08-25
Completion
2025-08-25
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 NCT05844423 on ClinicalTrials.gov