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Participants and/or participants' parents/LARs, who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, return for follow-up visits) |
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Written or witnessed/thumb printed informed consent obtained from the participant/participant's parent(s)/LAR(s) of the participant prior to performance of any study specific procedure |
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Written or witnessed/thumb printed informed assent obtained from participants below the legal age of consent prior to performance of any study specific procedure |
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Previous vaccination with 1 dose of MenACWY vaccine at an age of 10 years or older, with an interval of at least 4 years between the previous MenACWY vaccine and enrollment (informed consent and assent [as applicable]) into this study |
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A male or female between, and including, 15 and 25 years of age (i.e., 25 years and 364 days) at the time of the first vaccination |
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Healthy participants as established by medical history, physical examination, and clinical judgment of the investigator before entering into the study |
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Female participants 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 participants of childbearing potential may be enrolled in the study, if the |
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participant |
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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 intervention period and for 30 days after completion of the vaccination series |
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Current or previous, confirmed or suspected disease caused by N. meningitidis
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Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection within 60 days of enrollment
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History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s)/product
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Hypersensitivity, including allergy, to any component of vaccines, including diphtheria toxoid (CRM 197) and latex medicinal products or medical equipment whose use is foreseen in this study
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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 or modification of the immune system resulting from
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Autoimmune disorders (including, but not limited to: blood, endocrine, hepatic, muscular, nervous system or skin autoimmune disorders; lupus erythematosus and associated conditions; rheumatoid arthritis and associated conditions; scleroderma and associated disorders) or immunodeficiency syndromes (including, but not limited to: acquired immunodeficiency syndromes and primary immunodeficiency syndromes)
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Systemic administration of corticosteroids (oral/intravenous/intramuscular) for more than 14 consecutive days within 90 days prior to study vaccination until the following post vaccination blood sample. This will mean prednisone ≥20 mg/day (for adult participants and ≥0.5 mg/kg/day with maximum ≥20 mg/day for pediatric participants. Inhaled and topical steroids are allowed
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Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to study vaccination
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Administration of long-acting immune-modifying drugs at any time during the study period (e.g., infliximab)
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Any neuroinflammatory (including but not limited to: demyelinating disorders
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Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study
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encephalitis or myelitis of any origin), congenital neurological conditions
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encephalopathies, seizures (including all subtypes such as: absence seizures
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Use of any investigational or non-registered product (drug, vaccine, or medical device) other than the study vaccine(s)/product during the period beginning 30 days before the first dose of study vaccine(s)/product (Day -29 to Day 1), or planned use during the study period
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Previous vaccination against any group B meningococcal vaccine at any time prior to informed consent and assent as applicable (according to the participant's age)
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generalized tonic-clonic seizures, partial complex seizures, partial simple
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Previous vaccination with 2 or more doses of MenACWY vaccine
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seizures). History of febrile convulsions should not lead to exclusion
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Administration/planned administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before any dose of study vaccine(s)/product until the following post-vaccination blood sample
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Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non investigational vaccine/product (drug or medical device)
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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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Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to any vaccine/product dose until the following post-vaccination blood sample. For corticosteroids, this will mean prednisone equivalent ≥20 mg/day for adult participants and ≥0.5 mg/kg/day with maximum ≥20 mg/day for pediatric participants. Inhaled and topical steroids are allowed
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History of/current chronic alcohol and/or drug abuse
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Involvement in the study as a study staff member or being immediate dependents, family, or household member of a study staff member
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