Meningococcal disease is a rare but serious infection mainly caused by the bacterium Neisseria meningitides. It is a major cause of serious bloodstream infection (septicaemia) and meningitis (acute inflammation of the protective membranes covering the brain and spinal cord, known as the meninges) worldwide and is associated with significant mortality as well as serious long-term complications (sequelae) that will highly impact the survivors' quality of life such as amputations, hearing loss, and neurodevelopmental disabilities. This study aims to investigate the burden of meningococcal disease in the United Kingdom (UK) during the period 2008-2017 through analysis of data collected in the Clinical Practice Research Datalink (CPRD), linked to hospitalisation, outpatient visits, and death records. In addition, follow-up data will be collected to describe the occurrence of complications and long term sequelae in patients that experienced meningococcal disease. This will inform the burden of disease linked to meningococcal disease in the UK over this 10-year period. The findings of this study will be able to better inform vaccination policy and health economic evaluation.
Objectives: This study to describe the burden of meningococcal disease (MD) in the UK and the associated health care resources utilisation to better inform vaccination policy and health economic evaluation; from acute events to long term consequences of the disease.
Methods: We will use a cohort study design to retrospectively describe the incidence and the mortality rate due to MD in the UK between 2008 and 2017 using data from CPRD, HES, and mortality registry data.
To assess the occurrence of related-sequelae, a matched case-control study will be conducted. Patients with an event of MD will be identified during 2009-2017, and will be individually matched with up to four randomly selected controls, on age, gender, region, and index date for meningococcal and follow-up duration. Index date will be defined as the first meningococcal episode during this period. Baseline period will be defined by 12-month pre-index date and will be required to be eligible for inclusion for patients aged >/= 1 year. Follow-up period will be defined by all the reliable data available after index date.
Analysis: Incidence and mortality of MD will be described by age groups. The occurrence of sequelae will be analysed using Kaplan Meier curves; and multivariate analyses using Cox regression.
Objective 1: Epidemiology of meningococcal disease in the UK during the period 2008-2017
- Annual incidence rates of meningococcal disease (by year, age group and setting)
- Annual mortality rate due to meningococcal disease (by year and age group)
- Demographic characteristics of meningococcal disease at acute and follow up periods and deaths
Objective 2: Disease burden of meningococcal disease in the UK during the period 2008-2017
- Demographics characteristics at the index event
- High-risk conditions
- Occurrence of related complication and sequelae after the initial meningococcal infection
Caroline Amand - Chief Investigator - Sanofi Winthrop Industrie (France)
Sabine Tong - Corresponding Applicant - Sanofi Aventis Recherche & Développement (France)
Alexia Kieffer - Collaborator - SANOFI
Helene Bricout - Collaborator - Sanofi Pasteur MSD ( closed )
Moe Kyaw - Collaborator - SANOFI
HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data