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

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ClinicalTrials.gov Identifier: NCT00503165
Recruitment Status : Completed
First Posted : July 18, 2007
Last Update Posted : May 1, 2008
Sponsor:
Information provided by:
Public Health England

Brief Summary:

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 or disease Intervention/treatment Phase
Vaccination Biological: Menitorix (MenC and Hib conjugate) Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : July 2007
Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




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

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


Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00503165


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

ClinicalTrials.gov Identifier: NCT00503165     History of Changes
Other Study ID Numbers: StaMen
First Posted: July 18, 2007    Key Record Dates
Last Update Posted: May 1, 2008
Last Verified: February 2008

Keywords provided by Public Health England:
Menitorix
vaccine