NCT05844423

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

Randomized, Observer-Blind, Active-Controlled, Dose-Finding Study to Evaluate the Safety, Tolerability, and Immunogenicity of 24-Valent PCV (VAX-24) in Infants Given 4 Doses at 2, 4, 6, and 12-15 Months of Age With Pediatric Vaccines

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 802 (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 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

Type	Name	Description
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

Timeline

• Start date: 2023-03-29
• Primary completion: 2025-08-25
• Completion: 2025-08-25
• First posted: 2023-05-06
• Last updated: 2025-09-11

Locations

32 sites across 1 country: United States

Regulatory

• FDA-regulated drug study