Meningitis type B is a potentially life-threatening bacterial infection that causes inflammation of the lining around the brain and spinal cord. A new vaccine against meningitis B was introduced into the UK routine childhood vaccination programme in September 2015. As with many vaccines, the new meningitis B vaccine may cause fevers in infants in the days following vaccination. There is evidence however that the new vaccine may cause more and higher fevers than other vaccines. A high fever due to infection or a vaccine carries a risk of a fit/seizure in infants and small children. The purpose of this study is to investigate the possible risk of fits/seizures in infants following vaccination with the meningitis B vaccine by comparing trends of fits/seizures following vaccination both before and after the meningitis B vaccine was added to the routine vaccination programme. Additionally the study will evaluate whether inclusion of the new vaccine alongside the other well established vaccines is having any impact on uptake or delaying infants/parents returning to have their second and third doses of the meningitis vaccine or the other routine vaccines. The results of this study will provide valuable information on the safety of the new meningitis B vaccine.
The objectives of this study are firstly to investigate a potential risk of convulsions following vaccination with Men B vaccine in an ecological analysis by comparing incidence rates of convulsions following routine vaccination before and after the introduction of the Men B vaccine into the routine schedule. Age-specific incidence rates of convulsion following routine vaccination at 8 weeks, 16 weeks and 12 months of age in the 5 years prior to and 14 months after the introduction of Men B vaccine will be determined. Poisson regression analysis will assess temporal trends before and after the introduction of Men B vaccine. The second objective is to evaluate whether the introduction of the Men B vaccine is having an impact on infants/parents returning for subsequent doses on time. Timing of vaccination will be investigated for all 3 doses of Men B vaccine at 8, 16 weeks and 12 months, rotavirus vaccine at 8 and 12 weeks and pneumococcal vaccine at 8, 16 weeks and 12 months in time periods prior to and after the introduction of Men B vaccine. Kaplan-Meier curves presented for infants vaccinated either prior to or after the introduction of Men B vaccine.
Incidence of convulsions following routine vaccination at 8 weeks, 16 weeks, 12 months and 3 years 4 months; Timing of vaccination in relation to date of birth for infants vaccinated with routine childhood vaccinations.
Suzie Seabroke - Chief Investigator - MHRA
Suzie Seabroke - Corresponding Applicant - MHRA
Jenny Wong - Collaborator - MHRA