A Phase IV Study to Evaluate the Immunogenicity and Safety in UK Laboratory Workers of Menitorix
Menitorix is a combined Hib conjugate and meningococcal C conjugate vaccine made by GlaxoSmithKline. It is currently licensed and recommended as a booster vaccination for UK children in the second year of life.
It is important that staff who have a potential occupational exposure to infectious disease are afforded protection where possible. The licensure and availability of Menitorix provides the opportunity to vaccinate such staff.
Immune responses that are indicative of protection have been established for both Hib and meningococcal C disease. It is therefore proposed that the immune responses of those laboratory staff taking part be measured as data currently available following Menitorix vaccination is in naïve children and adults. This study will also allow us to provide occupational healthcare to laboratory workers.
Participation in the study would be offered to all those staff considered to be at occupational health risk of Hib or meningococcal C disease at the Manchester HPA site. This will be a single group study in that everyone enrolled will receive a single dose of Menitorix and will have blood collected prior to and 4-6 weeks following vaccination.
Assessment of whether protective levels of antibody have been achieved will be made using the blood sample taken 4-6 weeks after vaccination. Extra dose(s) will be offered to any subjects whose levels are not considered to confer protection as described later in this protocol. Subjects receiving and extra vaccination will be offered and a further blood test 4-6 weeks later to allow antibody levels to be checked again.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Phase IV, Single Group Study to Evaluate the Immunogenicity and Safety in UK Laboratory Workers of a Licensed Hib and Meningococcal C Conjugate Combined Vaccine (Menitorix)|
- Determine serum bactericidal antibody levels against Neisseria meningitis serogroup C. [ Time Frame: 1 month after vaccination ]
- Determine anti-Hib IgG concentration (ELISA) [ Time Frame: 1 month after vaccination ]
|Study Start Date:||July 2007|
|Study Completion Date:||August 2007|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00503165
|Health Protection Agency, Manchester Laboratory.|
|Manchester, United Kingdom, M13 9WZ|
|Principal Investigator:||Ed Kaczmarski, MBBS||Public Health England|