Trials / Completed

CompletedNCT05266456

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

A Phase 1/2, Randomized, Observer-Blind, Dose-Finding, Controlled, Parallel-Group, Two-Stage Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Healthy Adults Aged 18 to 64 Years

Status: Completed
Phase: Phase 1 / Phase 2
Study type: Interventional
Enrollment: 835 (actual)

Sponsor: Vaxcyte, Inc. · Industry
Sex: All
Age: 18 Years – 64 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 18 to 49 years of age in Phase 1. The Phase 2 will evaluate the safety, tolerability, and immunogenicity of a single injection of VAX-24 at 3 dose levels compared to PCV20 in adults aged 50 to 64 years of age in Phase 2.

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 18 to 49 years of age in Phase 1. The Phase 2 will evaluate the safety, tolerability, and immunogenicity 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 PCV20 in adults aged 50 to 64 years of age.

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	20 valent pneumococcal conjugate vaccine	0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1

Timeline

Start date: 2022-02-22
Primary completion: 2023-01-10
Completion: 2023-01-10
First posted: 2022-03-04
Last updated: 2024-04-18
Results posted: 2024-04-18

Locations

13 sites across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT05266456. Inclusion in this directory is not an endorsement.