Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-025)
Status:
Completed
Trial end date:
2021-08-05
Target enrollment:
Participant gender:
Summary
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
Prevenar 13™ for the 13 shared serotypes between V114 and Prevenar 13™ based on response
rates at 30 days post toddler dose (PTD); 2) V114 is superior to Prevenar 13™ for the 2
serotypes unique to V114 based on the response rates at 30 days PTD; 3) V114 is non-inferior
to Prevenar 13™ for the 13 shared serotypes between V114 and Prevenar 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.