Completion of Recommended Hepatitis Vaccination Schedules Among Adults in the United Kingdom

Study type
Protocol
Date of Approval
Study reference ID
17_226
Lay Summary

Vaccines work well at preventing harmful diseases in children and adults. Hepatitis A and B are two diseases that can be prevented with vaccination. The Hepatitis A vaccine requires two doses and the Hepatitis B vaccine requires three doses. It is important for an individual to receive all doses of each vaccine to be fully protected. It is unclear if people in the UK who get the first dose of each hepatitis vaccine come back to receive the remaining doses. We propose to determine the percentage of people in the UK who receive all doses of the hepatitis vaccines within the recommended schedules.

Technical Summary

The primary objective of the study is to estimate hepatitis A and B dose completion and adherence with the two- and three-dose schedules in an adult insured population in the UK. This is a retrospective database study using anonymised primary care electronic health record (EHR) data from January 1, 2009, through December 31, 2016. This study will use the Clinical Practice Research Datalink (CPRD). Health records from January 1, 2009, through December 31, 2016, will be used. The primary outcomes from this study are completion of 2 and 3 doses of hepatitis A and B vaccine over various time periods and adherence with the 2- and 3-dose recommended schedules. All analyses are exploratory. Median time to completion and the proportion of patients who completed 2 and 3 doses and complied with the recommended schedule within specific time periods of the first dose will be estimated using Kaplan-Meier survival curves.

Health Outcomes to be Measured

Compliance with the recommended timing of doses for hepatitis A, B and A/B vaccines; Completion of the recommended number of doses for hepatitis A, A/B, and B vaccines.

Collaborators

Kelly Johnson - Chief Investigator - Merck & Co., Inc.
Kelly Johnson - Corresponding Applicant - Merck & Co., Inc.
Dongmu Zhang - Collaborator - AbbVie Inc. USA (Headquarters)