NCT06720038

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

A Phase 2, Randomized, Double-Blind, Active-Controlled, Dose-Finding Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 in Healthy Infants Given 4 Doses at 2, 4, 6, and 12-15 Months of Age Concomitantly With Routine Pediatric Vaccines

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 905 (actual)
• Sponsor: Vaxcyte, Inc. · Industry
• Sex: All
• Age: 42 Days – 89 Days
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2024-11-25
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2024-12-06
• Last updated: 2026-01-26

Locations

48 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study