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A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 in Healthy Infants

NCT06720038 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2026-05-15

No results posted yet for this study

Summary

The objective of the study is to evaluate the safety, tolerability, and immunogenicity of 4 injections of VAX-31 (at 4 dose levels) compared to PCV20 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 approximately 352 subjects. Stage 3 of the study will enroll approximately 500 subjects.

Conditions

  • Pneumococcal Vaccines

Interventions

BIOLOGICAL

0.5 mL of the low dose VAX-31

31 valent pneumococcal conjugate vaccine

BIOLOGICAL

0.5 mL of the mid dose VAX-31

31 valent pneumococcal conjugate vaccine

BIOLOGICAL

0.5 mL of the high dose VAX-31

31 valent pneumococcal conjugate vaccine

BIOLOGICAL

0.5 mL dose of PCV20

20 valent pneumococcal conjugate vaccine

BIOLOGICAL

0.5 mL of the High-PFS dose VAX-31

31 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
2024-11-25
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

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 NCT06720038 on ClinicalTrials.gov