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A Phase IV Study to Evaluate the Immunogenicity and Safety in UK Laboratory Workers of Menitorix

This study has been completed.
Information provided by:
Public Health England Identifier:
First received: July 17, 2007
Last updated: April 30, 2008
Last verified: February 2008

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.

Condition Intervention Phase
Vaccination Biological: Menitorix (MenC and Hib conjugate) Phase 4

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:

Further study details as provided by Public Health England:

Primary Outcome Measures:
  • Determine serum bactericidal antibody levels against Neisseria meningitis serogroup C. [ Time Frame: 1 month after vaccination ]

Secondary Outcome Measures:
  • Determine anti-Hib IgG concentration (ELISA) [ Time Frame: 1 month after vaccination ]

Estimated Enrollment: 30
Study Start Date: July 2007
Study Completion Date: August 2007
  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • No contraindications to vaccination as specified in the "Green Book" - Immunisation Against Infectious Disease, HMSO.
  • Written informed consent

Exclusion Criteria:

  • Known or suspected pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00503165

United Kingdom
Health Protection Agency, Manchester Laboratory.
Manchester, United Kingdom, M13 9WZ
Sponsors and Collaborators
Public Health England
Principal Investigator: Ed Kaczmarski, MBBS Public Health England
  More Information Identifier: NCT00503165     History of Changes
Other Study ID Numbers: StaMen
Study First Received: July 17, 2007
Last Updated: April 30, 2008

Keywords provided by Public Health England:
vaccine processed this record on August 16, 2017