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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,015
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
AMR Mobile
Mobile, Alabama, United States
Percentage of Subjects Reporting Solicited Local Reactions Within 7 Days After Vaccination (Redness, Swelling, and Pain at Injection Site) 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 Subjects Reporting Solicited Systemic Events Within 7 Days After Vaccination (Fever, Headache, Fatigue, Muscle Pain, and Joint Pain) in Each Age Group 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 Subjects Reporting Unsolicited Adverse Event 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 1 month after vaccination.
Time frame: 1 month after vaccination
Percentage of Subjects Reporting Serious Adverse Event
Percentage of participants with SAEs.
Time frame: 6 months after vaccination
Percentage of Subjects Reporting New Onset of Chronic Illness
Percentage of participants with NOCIs
Time frame: 6 months after vaccination
Percentage of Subjects Reporting Medically Attended Adverse Event
Percentage of participants with MAAEs.
Time frame: 6 months after vaccination
Percentage of Subjects With Adverse Events Due to Clinically Significant Laboratory Values
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AMR Phoenix
Phoenix, Arizona, United States
Research Centers of America
Hollywood, Florida, United States
Health Awareness
Jupiter, Florida, United States
Optimal Research
Melbourne, Florida, United States
Precision Clinical Research
Sunrise, Florida, United States
Velocity Clinical Research, Savannah
Savannah, Georgia, United States
Healthcare Research Network II, LLC
Flossmoor, Illinois, United States
Johnson County Clin-Trials
Lenexa, Kansas, United States
DM Clinical Research - Detroit
Detroit, Michigan, United States
...and 15 more locations
Laboratory values that resulted in treatment and reporting as adverse events 1 month following vaccination.
Time frame: 1 month after vaccination
Percentage of Participants With a Shift From Normal at Baseline to Abnormal at Post-vaccination in Safety Laboratory Parameters (Hematology, Clinical Chemistry, Urinalysis)
Shifts from Normal at Baseline to Abnormal on Month 1 (30 days after vaccination) in Hematology, Clinical Chemistry and Urinalysis Parameters Occurring in Subjects Aged 50+ Years.
Time frame: 1 month after vaccination
31 VAX-31 Pneumococcal Serotype-specific OPA Geometric Mean Titer
Antibody geometric mean titers as measured by OPA for the 31 pneumococcal serotypes in VAX-31.
Time frame: 1 month after vaccination
31 VAX-31 Pneumococcal Serotype-specific IgG Geometric Mean Concentration
Antibody geometric mean concentrations as measured by IgG for the 31 pneumococcal serotypes in VAX-31.
Time frame: 1 month after vaccination