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A Phase 3, Multicenter, Randomized, Double-blind, Active-Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 4-dose Regimen of V114 in Healthy Infants (PNEU-PED)
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V114 in healthy infants. The primary hypotheses are that: 1) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes between V114 and Prevnar 13™ based on response rates at 30 days following Dose 3; 2) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on the response rate of the 2 unique V114 serotypes compared with the lowest response rate of any of the shared serotypes in Prevnar 13™, excluding serotype 3, at 30 days following Dose 3; 3) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes based on anti-pneumococcal polysaccharide (PnPs) serotype-specific immunoglobulin g (IgG) geometric mean concentrations (GMCs) at 30 days following Dose 3; 4) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on the anti-PnPs serotype-specific IgG GMCs of the 2 unique V114 serotypes compared with the lowest IgG GMC of any of the shared serotypes in Prevnar 13™, excluding serotype 3, at 30 days following Dose 3; 5) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes between V114 and Prevnar 13™ based on anti-PnPs serotype-specific IgG GMCs at 30 days following Dose 4; and 6) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on anti-PnPs serotype-specific IgG GMCs of the 2 unique V114 serotypes compared with the lowest IgG GMC of any of the shared serotypes in Prevnar 13, excluding serotype 3, at 30 days following Dose 4.
Age
0 - 0 years
Sex
ALL
Healthy Volunteers
Yes
Alabama Clinical Therapeutics ( Site 0159)
Birmingham, Alabama, United States
Southeastern Pediatric Associates, P.A. ( Site 0107)
Dothan, Alabama, United States
South Alabama Pediatrics ( Site 0263)
Opp, Alabama, United States
Northwest Arkansas Pediatric Clinic ( Site 0172)
Fayetteville, Arkansas, United States
Children's Clinic of Jonesboro, PA ( Site 0184)
Jonesboro, Arkansas, United States
Advanced Clinical Research - Rancho Paseo ( Site 0163)
Banning, California, United States
Altissima Clinical Research LLC ( Site 0213)
Bellflower, California, United States
Southland Clinical Research Center ( Site 0187)
Bellflower, California, United States
Premier Health Research Center, LLC ( Site 0121)
Downey, California, United States
Kaiser Permanente Vaccine Study Center - Oakland ( Site 0282)
Oakland, California, United States
Start Date
June 19, 2019
Primary Completion Date
May 24, 2021
Completion Date
May 24, 2021
Last Updated
July 28, 2023
1,720
ACTUAL participants
V114
BIOLOGICAL
Prevnar 13™
BIOLOGICAL
RotaTeq™
BIOLOGICAL
Pentacel™
BIOLOGICAL
RECOMBIVAX HB™
BIOLOGICAL
VAQTA™
BIOLOGICAL
MMR II™
BIOLOGICAL
VARIVAX™
BIOLOGICAL
HIBERIX™
BIOLOGICAL
Lead Sponsor
Merck Sharp & Dohme LLC
NCT06998251
NCT06000397
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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