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) - StaMen

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-004302-74-GB

Enrollment

Registered

2011-08-15

Start date

2007-05-22

Completion date

Unknown

Last updated

2019-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Interventions

Trade Name: Menitorix Product Name: Menitorix Product Code: n/a Pharmaceutical Form: Powder and solvent for solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: (1) Suspected or known pregnancy

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026