Structured Benefit-Risk Assessment of a New Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) in Individuals Ages 12 Months and Older.

ABSTRACT:

Introduction

A favorable benefit-risk balance is required to support licensure of biologics, in keeping with regulatory agencies' evolving recommendations, including the United States Food and Drugs Administration. We present a structured semi-quantitative benefit-risk analysis of MenACYW-TT, a quadrivalent meningococcal conjugate vaccine against Neisseria meningitidis serogroups, A, C, W and Y versus licensed comparators in individuals aged ≥ 12 months.

Methods

We used data from six MenACYW-TT clinical trials, stratified by age group, versus licensed vaccines: toddlers (12-23 months; Nimenrix^® [MCV4-TT]), children (2-9 years; Menveo^® [MCV4-CRM]), adolescents (10-17 years; MCV4-CRM or Menactra^® [MCV4-DT]), adults (18-55 years; MCV4-DT) and ol

SUBMITTER: Neveu D 

PROVIDER: S-EPMC10600069 | biostudies-literature | 2023 Oct

REPOSITORIES: biostudies-literature