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Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol or/and subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol |
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Previous vaccination with 1 dose of quadrivalent meningococcal conjugate vaccine (MenACWY, Menveo or Menactra) at least 4 years prior to informed consent and assent as applicable |
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Written or /witnessed/thumb printed informed consent obtained from the subject/parent(s)/LAR(s) of the subject prior to performance of any study specific procedure |
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Written informed assent obtained from the subject (if applicable) along with informed consent from the subject's parent(s)/LAR(s) prior to performing any study specific procedure |
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A male or female between, and including, 16 and 18 years of age at the time of the first vaccination |
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Healthy subjects as established by medical history and clinical examination before entering into the study |
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Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause |
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Female subjects of childbearing potential may be enrolled in the study, if the subject |
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has practiced adequate contraception for 30 days prior to vaccination, and |
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has a negative pregnancy test on the day of vaccination, and |
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has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series |
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Medical conditions
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Progressive, unstable or uncontrolled clinical conditions
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Clinical conditions representing a contraindication to intramuscular vaccination and blood draws
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Abnormal function of the immune system resulting from
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Clinical conditions
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Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to study vaccination. This will mean prednisone ≥ 20 mg/day (for adult subjects) or ≥ 0.5 mg/kg/day or 20 mg/day whichever is the maximum dose for pediatric subjects, or equivalent. Inhaled and topical steroids are allowed
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Administration of antineoplastic or immunomodulating agents or radiotherapy within 90 days prior to informed consent
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Are obese at screening (obesity is defined as a BMI of ≥ 95th percentile for age and gender)
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Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study
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History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines
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History of any reaction or hypersensitivity likely to be exacerbated by any medicinal products or medical equipment whose use is foreseen in this study
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Current or previous, confirmed or suspected disease caused by N. meningitidis
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Known contact to an individual with any laboratory-confirmed N. meningitidis infection within 60 days, prior to enrolment
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History of neuroinflammatory or autoimmune condition
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Recurrent history or un-controlled neurological disorders or seizures
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Prior/Concomitant therapy
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Use of any investigational or non-registered product other than the study vaccine(s) during the period starting 30 days before the informed consent or planned use during the study period
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Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 180 days before the informed consent or planned administration during the study period
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Previous vaccination with any group B meningococcal vaccine at any time prior to informed consent and assent as applicable
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Previous vaccination with 2 doses of quadrivalent meningococcal conjugate vaccine (MenACWY, Menveo or Menactra)
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Prior/Concurrent clinical study experience
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Subject concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product, will not be enrolled
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Other exclusions
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Child in care
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Pregnant or lactating female
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Female planning to become pregnant or planning to discontinue contraceptive precautions
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Any study personnel or immediate dependents, family, or household member
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