The objective of the study is to evaluate the safety, tolerability, and immunogenicity of 4 injections of VAX-31 (at 4 dose levels) compared to PCV20 in infants at 2, 4, 6, and 12-15 months of age, in addition to receiving routine US concomitant vaccines. Stage 1 of the study will comprise 3 dose ascending cohorts. Stage 2 of the study will enroll approximately 352 subjects. Stage 3 of the study will enroll approximately 500 subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
900
31 valent pneumococcal conjugate vaccine
31 valent pneumococcal conjugate vaccine
31 valent pneumococcal conjugate vaccine
Percentage of subjects with any solicited local injection site adverse events (AE) within 7 days after each vaccination
Solicited local reactions include erythema, edema, and tenderness at the injection site
Time frame: 7 days after each vaccination
Percentage of subjects with any solicited systemic AE within 7 days after each vaccination
Solicited systemic reactions include fever, irritability, decreased appetite, decreased sleep, and increased sleep
Time frame: 7 days after each vaccination
Percentage of subjects with any unsolicited AE within 1 month after each vaccination
Percentage of subjects with unsolicited AE
Time frame: 1 months after each vaccination
Percentage of subjects with any medically attended adverse events (MAAE) within 6 months after last vaccination
Percentage of subjects with MAAE
Time frame: 6 months after last vaccination
Percentage of subjects with any Serious Adverse Events (SAE) within 6 months after last vaccination
Percentage of subjects with SAE
Time frame: 6 months after last vaccination
Percentage of subjects with any new onset of chronic illness (NOCI) within 6 months after last vaccination
Percentage of subjects with NOCI
Time frame: 6 months after last vaccination
Percentage of subjects achieving a serotype-specific anti-pneumococcal IgG antibody concentration ≥0.35 mcg/mL 1 month after Dose 3
Percentage of subjects achieving a serotype-specific anti-pneumococcal IgG antibody concentration ≥0.35 mcg/mL
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20 valent pneumococcal conjugate vaccine
31 valent pneumococcal conjugate vaccine
The Children's Clinic of Jonesboro, P.A
Jonesboro, Arkansas, United States
Matrix Clinical Research
Gardena, California, United States
Matrix Clinical Research
Los Angeles, California, United States
Orange County Research Institute
Ontario, California, United States
Center for Clinical Trials of San Gabriel
West Covina, California, United States
Children's Hospital of Colorado - Dept. of Infectious Disease
Aurora, Colorado, United States
SEC Clinical Research
Pensacola, Florida, United States
PAS Research
Tampa, Florida, United States
Clinical Research Prime, LLP
Idaho Falls, Idaho, United States
Clinical Research Prime - Rexburg
Rexburg, Idaho, United States
...and 38 more locations
Time frame: 1 month after Dose 3
Serotype-specific IgG antibody geometric mean concentration (GMC) 1 month after Dose 3
Antibody geometric mean concentrations as measured by IgG for the 31 pneumococcal serotypes in VAX-31
Time frame: 1 month after Dose 3
Serotype-specific IgG antibody GMC 1 month after Dose 4
Antibody geometric mean concentrations as measured by IgG for the 31 pneumococcal serotypes in VAX-31
Time frame: 1 month after Dose 4