A PHASE II, OPEN LABEL, RANDOMISED, SINGLE CENTRE STUDY TO EVALUATE THE SAFETY, REACTOGENICITY AND IMMUNOGENICITY OF THREE OR FOUR DOSES OF MENINGOCOCCAL SEROGROUP B OUTER MEMBRANE VESICLE (OMV) VACCINE MENZBTM WHEN ADMINISTERED TO HEALTHY ADULTS (UNIVERSITY STUDENTS)
- Conditions
- Prevention of invasive disease caused by N. meningitidis serogroup B
- Registration Number
- EUCTR2005-003570-22-GB
- Lead Sponsor
- Health Protection Agency
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1) Informed written consent given for four immunisations (group 2 will receive 3 doses only) with MeNZB TM vaccine, as well as for eight blood draws to be taken as described in the patient information leaflet in appendix 2
2) Healthy adults (university students) aged 18 up to 40 years on inclusion in the study
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
·Previous history of bacteriologically confirmed disease caused by N. meningitidis
·Prior receipt of any group B meningococcal vaccine
·have had household contact with and/or intimate exposure to an individual with culture or PCR proven N. meningitidis serogroup B within the previous 60 days
·have either received, or for whom there is intent to immunize with, any vaccines or investigational agents within 50 days prior to enrolment, through to 50 days following the last study vaccine administration, with the exception of influenza vaccines or post-exposure tetanus vaccination
·have a history of any anaphylactic shock, urticaria or other allergic reaction after previous vaccinations or hypersensitivity to any vaccine component
·have experienced significant acute or chronic infections requiring systemic antibiotic treatment within the past 14 days
·have any present or suspected serious acute or chronic disease such as: cardiac or autoimmune disease, insulin dependent diabetes or progressive neurological disease or severe malnutrition, acute or progressive hepatic disease, acute or progressive renal disease; leukaemia, lymphomas, neoplasm;
·have a known or suspected impairment of the immune function, or those receiving immunosuppressive therapy, or having received immunosuppressive therapy, including systemic steroids, or ACTH or inhaled steroids in dosages which are associated with hypothalamic-pituitary-adrenal axis suppression;
·have received blood, blood products or a parenteral immunoglobulin preparation in the past 12 weeks;
·have a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
·have a history of seizure disorder;
·have an inherited genetic anomaly (known cytogenic disorders) e.g., Down’s syndrome;
·Language difficulty sufficient to preclude adequate comprehension of the information sheet, consent form or study nurse’s explanation of the study;
·The possibility of pregnancy – a pregnancy test (urine) on the scheduled day of vaccination will be offered to any female wishing to participate in the study. A positive test 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 final blood sample appointment following their final vaccination, i.e. until the week 63 – visit 8 - blood appointment);
·Current regimen of chronic prescription medications other than oral contraceptives, or current regular use of any over-the-counter concomitant medications including antipyretics and non-steroidal anti-inflammatory agents;
·Current participation in any other clinical trial (an undertaking will be sought from participants not to enrol in any other clinical trial for the duration of this study);
·They have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
Current (to be checked prior to each vaccination):
·Generalised acute systemic illness on the day of immunisation
·Sublingual temperature >38,5oC on the day of im
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method