Last updated on December 2019

Safety Tolerability and Immunogenicity of V114 in Healthy Infants (V114-025)


Brief description of study

This study will evaluate the safety and tolerability and immunogenicity of V114 when administered to 2-month old infants. The primary hypotheses are: 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 post toddler dose (PTD);2) V114 is superior to Prevnar 13 for the 2 serotypes unique to V114 based on the response rates at 30 days PTD; 3) V114 is non-inferior to Prevnar 13 for the 13 shared serotypes between V114 and Prevnar 13 based on anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobin G (IgG) geometric mean concentrations (GMCs) at 30 days PTD; and 4) V114 is superior to Prevenar 13 for the 2 serotypes unique to V114 based on anti-PnPs serotype-specific IgG GMCs at 30 days PTD.

Clinical Study Identifier: NCT04031846

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Kinderarztpraxis ( Site 0068)

Moenchengladbach, Germany
0.98miles
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