The study investigates the ability of the two vaccines to induce protective immunity against meningococcal disease.
Conditions
Interventions
Product Name: MenB vaccine
Product Code: rMenB + OMV NZ
Pharmaceutical Form: Solution for injection
INN or Proposed INN: N. meningitidis 961c purified antigen
Current Sponsor code: 961c
Concentration
Sponsors
Health Protection Agency
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: (1) Male and female adults aged 18 to 65 years at enrolment. (2) Who have given written informed consent (see appendix 1 for consent form) after the nature of the study has been explained. (3) Who work within the Manchester Medical Microbiology Partnership and may be at potential occupational exposure to meningococci. 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: Exclusion criteria: (1) The possibility of pregnancy – a pregnancy test (urine) on the scheduled day of vaccination will be offered for any female wishing to participate in the study as well as giving basic menstrual cycle information to cover the period in which and individual may be pregnant but this would not be ascertained by the chemical test. A positive test or suspected pregnancy by the individual or a study clinician will result in exclusion from the study (agreement from each female participants will be sought prior to vaccination that they will take adequate precautions to avoid pregnancy for the duration of the vaccination phase of the study until the blood sample appointment following their final vaccination, i.e. until visit 5 at 7 months). (2) A serious chronic disease including progressive neurological disease or seizure disorder. (3) Have a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time. (4) Have a history of severe allergic reactions after previous vaccinations such as anaphylactic shock, asthma, urticaria, or other allergic reaction or hypersensitivity to any vaccine component. (5) Have received another investigational agent within 90 days or before completion of the safety follow-up period in another study, whichever is longer, prior to enrollment and unwilling to refuse participation in another investigational trial through the end of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principal objective of the study is to offer the two meningococcal vaccines to staff at the Manchester Medical Microbiology Partnership which may be at potential occupational exposure to meningococci. This will have the benefit of potentially providing protection against disease in these subjects. ;Secondary Objective: The secondary objectives are to explore the safety and immunogenicity of the vaccines in laboratory workers. This will provide information on the ability of the vaccines to induce a cross-reactive response to other meningococci which are not included in the vaccine. This information will be used to inform future immunisation policy in this occupational group which may be at potential exposure to meningococci. This is pertinant as there is currently no available licensed group B vaccine and a poorly immunogenic ACYW vaccine.;Primary end point(s): The primary outcome measure for the study will be the proportions of subjects attaining serum bactericidal antibody titres >= 4 against MenB target strains (measured with human complement) and >= 8 against MenA, C, Y and W135 strains (measured with rabbit complement). These are the accepted correlates of protection and hence the study will measure the proportions of subjects attaining these levels. | — |
Countries
United Kingdom
Outcome results
None listed