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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
207
0.5 ml dose of VAX-24 will be administered into the deltoid muscle at Day 1
0.5 ml dose of Prevnar 20 will be administered into the deltoid muscle at Day 1
Accel Research Sites-Birmingham Clinical Research Unit
Birmingham, Alabama, United States
Percentage of Participants Reporting Solicited Local Reactions Within 7 Days After Vaccination
Solicited local reactions included redness/erythema, swelling/induration, and pain at injection site
Time frame: 7 days after vaccination
Percentage of Participants Reporting Solicited Systemic Events Within 7 Days After Vaccination
Solicited systemic reactions include fever, headache, fatigue, muscle pain, and joint pain within 7 days of vaccination
Time frame: 7 days after vaccination
Percentage of Subjects Reporting Unsolicited Adverse Events Within 1 Month After Vaccination
Percentage of participants with at least one Treatment Emergent Adverse Event (unsolicited AEs and SAEs)
Time frame: 1 month after vaccination
Percentage of Participants Reporting SAEs and New Onset of Chronic Illnesses (NOCIs)
Percentage of participants with serious adverse events (SAEs) and new onset of chronic illness (NOCIs)
Time frame: 6 months after vaccination
VAX-24 Pneumococcal Serotype-specific Opsonophagocytic Assay (OPA) Geometric Mean Titer (GMTs)
The change from baseline to 1 month post-vaccination in the immune response directed against each of the 24 serotypes was evaluated by measuring serotype-specific functional antibody responses with an opsonophagocytic (OPA) assay that assesses the functional capacity of pneumococcal antibodies.
Time frame: 1 month after vaccination
24 VAX-24 Pneumococcal Serotype-specific IgG Geometric Mean Concentration (GMCs)
The change from baseline to 1 month post-vaccination in the immune response directed against each of the 24 serotypes was evaluated by measuring IgG levels using an IgG multiplexed electrochemoluminescent assay (ECLA). Values below the lower limit of quantitation (LLOQ) were analyzed as 0.5\*LLOQ. Values above the upper limit of quantitation (ULOQ) were analyzed as 1\*ULOQ.
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Accel Research Sites - DeLand Clinical Research Unit
DeLand, Florida, United States
CenExel RCA
Hollywood, Florida, United States
Precision Clinical Research
Sunrise, Florida, United States
Meridian Clinical Research
Savannah, Georgia, United States
Pivotal Research Solutions
Stonecrest, Georgia, United States
Healthcare Research Network II, LLC
Flossmoor, Illinois, United States
AMR Newton, formerly Heartland Research Associates
Newton, Kansas, United States
AMR Wichita West
Wichita, Kansas, United States
AMR New Orleans
New Orleans, Louisiana, United States
...and 10 more locations
Time frame: 1 month after vaccination