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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.
Sponsor:
Information provided by:
Health Protection Agency, United Kingdom
ClinicalTrials.gov Identifier:
NCT00503165
First received: July 17, 2007
Last updated: April 30, 2008
Last verified: February 2008
  Purpose

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: 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)

Resource links provided by NLM:


Further study details as provided by Health Protection Agency, United Kingdom:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: NCT00503165

Locations
United Kingdom
Health Protection Agency, Manchester Laboratory.
Manchester, United Kingdom, M13 9WZ
Sponsors and Collaborators
Health Protection Agency, United Kingdom
Investigators
Principal Investigator: Ed Kaczmarski, MBBS Health Protection Agency, United Kingdom
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00503165     History of Changes
Other Study ID Numbers: StaMen
Study First Received: July 17, 2007
Last Updated: April 30, 2008
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Health Protection Agency, United Kingdom:
Menitorix
vaccine

ClinicalTrials.gov processed this record on November 23, 2014