NCT06151288

Safety, Tolerability, and Immunogenicity Study of a 31-Valent Pneumococcal Conjugate Vaccine (VAX-31) in Adults

A Phase 1/2, Randomized, Observer-Blind, Dose-Finding, Active-Controlled, Parallel-Group, Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 31-Valent Pneumococcal Conjugate Vaccine (VAX-31) in Healthy Adults Aged 50 Years and Older

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 1,015 (actual)
• Sponsor: Vaxcyte, Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

The objective of the study is to evaluate the safety, tolerability and immunogenicity of a single injection of VAX-31 at 3 dose levels compared to Prevnar 20™ (PCV20) in adults 50 to 64 years of age in Stage 1. Stage 2 will evaluate the safety, tolerability, and immunogenicity of a single injection of VAX-31 at 3 dose levels compared to PCV20 in adults aged 50 years and older.

Conditions

• Pneumococcal Vaccines

Interventions

Type	Name	Description
BIOLOGICAL	31 valent pneumococcal conjugate vaccine	0.5 ml dose of VAX-31 was administered into the deltoid muscle at Day 1
BIOLOGICAL	20 valent pneumococcal conjugate vaccine	0.5 ml dose of PCV20 was administered into the deltoid muscle at Day 1

Timeline

• Start date: 2023-11-08
• Primary completion: 2024-07-17
• Completion: 2024-07-17
• First posted: 2023-11-30
• Last updated: 2025-07-28
• Results posted: 2025-07-28

Locations

25 sites across 1 country: United States

Regulatory

• FDA-regulated drug study