Assessment of the rate of vaccine co-administrations with Bexsero

Study type
Protocol
Date of Approval
Study reference ID
17_007
Lay Summary

The Meningitis B vaccine Bexsero has been introduced in the England National Health Service (NHS) Childhood Immunisation Program on September 1st, 2015. The aim of this analysis is to determine at what age the first, second, third, fourth or any dose of the Meningitis B vaccine Bexsero are administered to subjects and which other vaccines, and combinations thereof, are co-administered on the same day, if any. This knowledge will support future studies on the potential link between administration of Bexsero and any type of adverse events following immunisation.

Technical Summary

The aim of this analysis is to obtain the distribution of age at administration of first, second, third, fourth or any dose of Bexsero vaccine and the frequencies of single and multiple co-administrations with Bexsero by age group. This will be performed in the CPRD. The observation period will start from September 1st, 2015 up to the latest available date by the time of this analysis (currently June 2016 for the 2016 Q3 release). This corresponds to the period from which Bexsero was introduced in the NHS Childhood Immunisation Program in England, in which infants are offered the MenB vaccine together with other routine vaccinations at 2 months, 4 months and 12 to 13 months of age. This knowledge will support pharmacovigilance evaluations (including the design of pharmacoepidemiological studies) of safety signals occurring after administration of Bexsero.

Health Outcomes to be Measured

Age at Bexsero vaccination; Type of vaccinations occurring on the same day as Bexsero.

Collaborators

Olivia Mahaux - Chief Investigator - GlaxoSmithKline - UK
Emmanuel ARIS - Corresponding Applicant - GlaxoSmithKline Biologicals SA (Belgium)
Lingling Yue - Collaborator - GSK Vaccines
Vincent Bauchau - Collaborator - UCB Pharma SA - UK