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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
835
0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
0.5 ml dose of PCV20 will be administered into the deltoid muscle at Day 1
CenExel RCA
Hollywood, Florida, United States
Precision Clinical Research
Sunrise, Florida, United States
Meridian Clinical Research
Savannah, Georgia, United States
Percentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination in Each Age Group
Solicited local reactions include redness/erythema, swelling/induration, and pain at injection site within 7 days after vaccination in each age group
Time frame: 7 days after vaccination
Percentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination in Each Age Group
Solicited systemic reactions include fever, headache, fatigue, muscle pain, and joint pain
Time frame: 7 days after vaccination
Percentage of Participants Reporting Unsolicited Adverse Events (AE) in Each Age Group
Percentage of participants in each age group with adverse events (AEs) whose date of onset occurs after the study vaccine and within the 28 days after vaccination.
Time frame: 1 month after vaccination
Percentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCI)
Percentage of participants with SAEs and NOCIs
Time frame: 6 months after vaccination
Percentage of Participants With Laboratory Value Abnormalities and/or Potentially Clinically Significant Laboratory Values
Shifts from Normal at Baseline to Abnormal on Day 29 in Clinical Chemistry Parameters Occurring in \>5% of Subjects Aged 50 to 64 Years
Time frame: 1 month after vaccination
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
Antibody geometric mean titers as measured by OPA for the 24 pneumococcal serotypes in VAX-24
Time frame: 1 month after vaccination
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Velocity Clinical Research
Valparaiso, Indiana, United States
Johnson County Clin-Trials
Lenexa, Kansas, United States
Benchmark Research
Metairie, Louisiana, United States
Alliance for Multispecialty Research
Kansas City, Missouri, United States
Rochester Clinical Research
Rochester, New York, United States
Acellacare of Wilmington
Wilmington, North Carolina, United States
Velocity Clinical Research
Warwick, Rhode Island, United States
...and 3 more locations
VAX-24 Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMCs)
Antibody geometric mean concentrations as measured by IgG for the 24 pneumococcal serotypes in VAX-24
Time frame: 1 month after vaccination