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

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 older adults (≥ 56 years; Menomune-A/C/Y/W-135 [MPSV4]).

A cross-sectional survey to evaluate prescribers' knowledge and understanding of safety messages following Dengvaxia® product information update.

Purpose: We evaluated the effectiveness of additional risk minimisation measures (aRMMs; i.e., educational materials) distributed to prescribers to ensure that only individuals with evidence of prior dengue infection (PDI, i.

Quantitative benefit-risk assessment by MCDA of the quadrivalent HPV vaccine for preventing anal cancer in males.

Objectives: To quantify the benefit-risk (BR) balance of the quadrivalent human papillomavirus (qHPV) vaccine for use in males, including anal cancer prevention, by using the multicriteria decision analysis (MCDA).

Methods: Value tree and an effect table were compiled using relevant qHPV vaccine efficacy/safety data. An expert panel validated the final model inputs.

Estimation of background incidence rates of Guillain-Barré syndrome in Germany - a retrospective cohort study with electronic healthcare data.

Background: The Guillain-Barré syndrome (GBS) occurs after infections and as an adverse reaction to vaccines. No detailed information on incidence rates (IRs) in Germany is available.

Methods: This retrospective cohort study estimated age- and sex-specific IRs of GBS in Germany in the years 2007-2009 based on electronic healthcare data from the German Pharmacoepidemiological Research Database (GePaRD).

Epidemiology and burden of rotavirus diarrhea in day care centers in Lyon, France.

This study gives, for the first time, an estimate of the incidence and the cost of rotavirus infection in day care centers in Lyon, France.