CLINICAL TRIALS PROFILE FOR VAXELIS
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All Clinical Trials for VAXELIS
Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
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NCT04016714 ↗ | 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™. |
NCT04490499 ↗ | 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. |
NCT04978818 ↗ | 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. |
NCT04978818 ↗ | Immunogenicity of H. Influenzae Type b PRP-OMP Vaccines in American Indian and Alaska Native Children (the HibVax Study) | Not yet recruiting | Johns Hopkins Bloomberg School of Public Health | 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. |
>Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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