Last updated on December 2019

Safety Tolerability and Immunogenicity of V114 in Healthy Infants (V114-029)


Brief description of study

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 superior to Prevnar 13 for the 2 serotypes unique to V114 based on response rates at 30 days following Dose 3; 3) V114 is non-inferior to Prevnar 13 based on anti-pneumococcal polysaccharide (PnPs) serotype-specific immunoglobulin g (IgG) geometric mean concentrations (GMCs) at 30 days following Dose 3; 4) V114 is superior to Prevnar 13 for the 2 serotypes unique to V114 based on anti-PnPs serotype-specific IgG GMCs 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 superior to Prevnar 13 for the 2 serotypes unique to V114 based on anti-PnPs serotype-specific IgG GMCs at 30 days following Dose 4.

Clinical Study Identifier: NCT03893448

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