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

NCT00503165 | Completed Phase 4

• 1 other identifier: StaMen
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaccination

Keywords

Menitorix; vaccine

Outcome Measures

Primary Outcomes (1)

• Determine serum bactericidal antibody levels against Neisseria meningitis serogroup C.

  1 month after vaccination

Secondary Outcomes (1)

• Determine anti-Hib IgG concentration (ELISA)

  1 month after vaccination

Interventions

Menitorix (MenC and Hib conjugate) BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Known or suspected pregnancy

Sponsors & Collaborators

• Public Health England: lead

Study Sites (1)

Health Protection Agency, Manchester Laboratory.

Manchester, M13 9WZ, United Kingdom

Location

Related Publications (1)

• Findlow J, Findlow H, Frankland S, Holland A, Holme D, Newton E, Southern J, Waight P, Kaczmarski E, Miller E, Borrow R. Evaluation of the safety and immunogenicity in United Kingdom laboratory workers of a combined Haemophilus influenzae type b and meningococcal capsular group C conjugate vaccine. J Occup Med Toxicol. 2014 Jul 16;9:26. doi: 10.1186/1745-6673-9-26. eCollection 2014.

  PMID: 25071861 BACKGROUND

Related Links

• Published study results

Study Officials

• Ed Kaczmarski, MBBS

  Public Health England

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: July 17, 2007
• First Posted: July 18, 2007
• Study Start: July 1, 2007
• Study Completion: August 1, 2007
• Last Updated: March 22, 2019

Record last verified: 2008-02

Locations

GB (1)