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) - StaMe
Phase 1
- Conditions
- Investigating the immunogenicity and safety of a licensed Hib and meninigococcal C combined conjugate vaccine (Menitorix) in laboratory workers.MedDRA version: 14.0 Level: LLT Classification code 10027276 Term: Meningococcal meningitis System Organ Class: 10021881 - Infections and infestations
- Registration Number
- EUCTR2006-004302-74-GB
- Lead Sponsor
- Health Protection Agency
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Inclusion criteria will be verbally checked with potential study participants prior to enrolment. Inclusion criteria are; (1) Members of staff at manchester Health Protection Agency with occupational risk of Hib and meningococcal C disease. (2) No contradictions to vaccination as specified in the green book-Immunisation Against Infectious Disease, HMSO. (3) Written informed consent from the study participant.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
(1) Suspected or known pregnancy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: n/a;Main Objective: To determine the responses in health adults to vaccination with the meningococcal C/Hib vaccine, Menitorix, currently used for the vaccination of infants. This will provide data on the efficacy of the vaccine in this age group and hopefully provide protection to laboratory workers with an increased risk of meningococcal C and Hib disease.;Primary end point(s): The primary outcome measures are the proportions of subjects attaining meningococcal serogroup C serum bactericidal antibody (SBA) equal or greater to 8, and Hib IgG equal or greater to 0.15 ug/mL. These are the accepted correlates of protection, hence the study will measure the proportion of subjects achieving these protective levels.
- Secondary Outcome Measures
Name Time Method