NCT05297578

Safety, Tolerability, and Immunogenicity Study of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Older Adults

A Phase 2, Randomized, Observer-Blind, Dose-Finding, Controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Healthy Adults 65 Years and Older

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 207 (actual)
• Sponsor: Vaxcyte, Inc. · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

The objective of the study is to evaluate the safety and tolerability of a single injection of VAX-24 at 3 dose levels compared to Prevnar 20™ (PCV20) in adults 65 years of age and older.

Detailed description

The objective of the study is to evaluate the safety and tolerability of a single injection of VAX-24 at 3 dose levels (Low: 1.1 mcg; Mid: 2.2 mcg; or Mixed: 2.2/4.4 mcg) compared to Prevnar 20™ (PCV20) in adults 65 years of age and older.

Conditions

• Pneumococcal Vaccines

Interventions

Type	Name	Description
BIOLOGICAL	24-Valent Pneumococcal Conjugate Vaccine	0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
BIOLOGICAL	Pneumococcal 20-valent Conjugate Vaccine	0.5 ml dose of Prevnar 20 will be administered into the deltoid muscle at Day 1

Timeline

• Start date: 2022-06-15
• Primary completion: 2023-02-15
• Completion: 2023-02-15
• First posted: 2022-03-28
• Last updated: 2024-10-09
• Results posted: 2024-04-16

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated drug study