A phase 2, open-label study of the safety, tolerability and immunogenicity of a Novartis meningococcal B vaccine when administered at a 0, 2, 6 month schedule and of a single dose of Novartis meningococcal ACWY conjugate vaccine in healthy adults aged 18-65 years. - Phase II MenB and MenACWY adult study

Health Protection Agency0 个研究点目标入组 75 人开始时间: 2010年3月15日最近更新: 2012年3月19日

试验速览

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•(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

•(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.

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