Influvac Tetra: clinical experience on safety, efficacy, and immunogenicity.

Introduction: This paper summarizes the safety and immunogenicity data of Influvac Tetra across all age groups starting from 6 months of age, obtained during its clinical development program.

Areas Covered: The article covers the clinical development program of Influvac Tetra based on five registration studies that included different age groups, different comparators, and participants from Europe and Asia. Safety and immunogenicity were assessed in all studies and in one study, the efficacy of Influvac Tetra was assessed.

Enhanced passive safety surveillance of Influvac® and Influvac® Tetra: Results from seven consecutive seasons.

Background And Objectives: In 2014, the European Medicines Agency (EMA) set out requirements for an enhanced safety surveillance for seasonal influenza vaccines. This paper presents data from the yearly Enhanced Passive Safety Surveillance (EPSS) implemented for Influvac® since season 2014/15 and continued for Influvac® Tetra from season 2018/19 onwards.

Methods: In seven consecutive seasons, an EPSS, aiming for at least 1,000 vaccinees (additional target of 100 vaccinees per five predefined age groups), was conducted in Germany, where market characteristics were expected to allow for a quick generation of representative data.

Development of the COVID-19-Anxiety Questionnaire and first psychometric testing.

The coronavirus disease 2019 (COVID-19) pandemic may cause psychological distress in the general population and has the potential to cause anxiety regarding COVID-19. No validated questionnaires exist for the measurement of specific COVID-19 anxiety. We modified the DSM 5 - Severity Measure for Specific Phobia-Adult scale specifically for anxiety regarding COVID-19, and report the psychometric properties from an online study with 6262 participants from the general population in Germany.

Associations between COVID-19 related media consumption and symptoms of anxiety, depression and COVID-19 related fear in the general population in Germany.

In context of the current COVID-19 pandemic the consumption of pandemic-related media coverage may be an important factor that is associated with anxiety and psychological distress. Aim of the study was to examine those associations in the general population in Germany. 6233 participants took part in an online-survey (March 27th-April 6th, 2020), which included demographic information and media exploitation in terms of duration, frequency and types of media.

Risk, resilience, psychological distress, and anxiety at the beginning of the COVID-19 pandemic in Germany.

Background: The current COVID-19 pandemic comes with multiple psychological stressors due to health-related, social, economic, and individual consequences and may cause psychological distress. The aim of this study was to screen the population in Germany for negative impact on mental health in the current COVID-19 pandemic and to analyze possible risk and protective factors.

Methods: A total of 6,509 people took part in an online survey in Germany from 27 March to 6 April.

Physical activity in outpatients with mental disorders: status, measurement and social cognitive determinants of health behavior change.

Introduction: Physical activity (PA) can play an important role in improving the mental and physical health in patients with mental disorders but is not well studied in this population. The aim of this study was to assess the status of PA in outpatients with mental disorders, compare the convergence of self-rating and accelerometer measurement and examine the influence of social cognitive variables from the Motivation-Volition (MoVo) model and clinical measures on PA.

Methods: Eighty-four patients were recruited from three psychiatric outpatient clinics and local psychiatrists (Distribution of ICD-10-Diagnoses: F3.