Safety, Tolerability, and Immunogenicity of a 3-dose Regimen of V114 in Healthy Infants (PNEU-PED-EU-2/V114-026)
Completed
Merck Sharp & Dohme Corp.
Phase 3
2019-08-28
The purpose of this clinical study is to evaluate the safety and immunogenicity of a 3-dose
schedule (2-dose primary series followed by a toddler dose) of pneumococcal conjugate vaccine
(PCV) as one of the currently recommended by the World Health Organization (WHO) Strategic
Advisory Group of Experts (SAGE) on Immunizations and practiced in many countries.
The primary hypotheses are that V114 is non-inferior to Prevnar 13® for the 13 shared
serotypes based on response rates and on anti-pneumococcal polysaccharide (PnPs)
serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) at 30 days
following Dose 3; that V114 is superior to Prevnar 13® for the 2 serotypes unique to V114
based on the response rates and on anti-PnPs serotype-specific IgG GMCs at 30 days following
Dose 3; and that Vaxelis™ administered concomitantly with V114 is non-inferior to Vaxelis™
administered concomitantly with Prevnar 13® at 30 days following Dose 3 for each antigen
included in Vaxelis™.
A Hepatitis B Vaccine Challenge Study After Previous Vaxelis® Vaccination. (V419-013)
Not yet recruiting
Merck Sharp & Dohme Corp.
Phase 3
2020-09-07
The purpose of this study is to demonstrate the durability of protection against hepatitis B
virus (HBV) infection approximately 9 years after vaccination with Vaxelis®. This is an
estimation study, and no formal hypothesis testing will be performed.
Immunogenicity of H. Influenzae Type b PRP-OMP Vaccines in American Indian and Alaska Native Children (the HibVax Study)
Not yet recruiting
Merck Sharp & Dohme Corp.
Phase 4
2021-11-15
The main goal of this study is to compare the Haemophilus influenzae type b antibody response
in American Indian / Alaska Native (AI/AN) infants to two licensed vaccines: Vaxelis and
PedvaxHIB.
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