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

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 / Drugs

0.5 mL of the low dose VAX-31 0.5 mL of the mid dose VAX-31 0.5 mL of the high dose VAX-31 0.5 mL dose of PCV20 0.5 mL of the High-PFS dose VAX-31

View on ClinicalTrials.gov ↗

Sponsor

Study Details

Enrollment905 participants

Primary Completion—

Lead SponsorVaxcyte, Inc.

Data Retrieved2026-04-11 04:24:14.205309+00:00

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