At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating 31 valent pneumococcal conjugate vaccine and 20 valent pneumococcal conjugate vaccine for Pneumococcal Vaccines. Completed, enrolled 1,015 participants across 25 sites.
Detailed 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.
Study Details
Timeline
Interventions
0.5 ml dose of VAX-31 was administered into the deltoid muscle at Day 1
0.5 ml dose of PCV20 was administered into the deltoid muscle at Day 1