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All inclusion criteria are applicable for both study phases, except where specified |
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otherwise |
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Participants and/or participants' parent(s)/Legally Acceptable Representative(s) (LAR) |
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who, in the opinion of the investigator, can and will comply with the requirements of |
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the protocol (e.g. completion of the eDiaries, return for follow-up visits) |
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Written or witnessed/thumb printed informed consent obtained from the participant or |
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parent(s)/LAR(s) of the participant prior to performance of any study specific |
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procedure |
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Written informed assent obtained from the participant (if applicable) prior to |
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performing any study specific procedure |
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Phase I only: A male or female between, and including, 18 and 40 years of age (i.e. 40 |
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Female participants of childbearing potential may be enrolled in the study, if the |
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years + 364 days) at the time of the first study intervention administration |
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participant |
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Phase II (Formulation and Schedule-finding) only: A male or female between, and |
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including, 10 and 25 years of age (i.e. 25 years + 364 days) at the time of the first |
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study intervention administration |
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Phase II (Sourcing) only: A male or female between, and including, 18 and 50 years of |
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age (i.e. 50 years + 364 days) at the time of the first study intervention |
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administration |
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Participants who are either unvaccinated with MenACWY vaccine or have received a |
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single previous dose of MenACWY vaccine can participate in the study, if they have |
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received it at least 4 years prior to informed consent and assent as applicable (with |
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the exception of meningococcal C vaccination, if the last dose of MenC was received at |
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≤24 months of age) |
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Healthy participants as established by medical history and clinical examination before |
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entering into the study |
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Female participants of non-childbearing potential may be enrolled in the study |
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Non-childbearing potential is defined as pre-menarche, current bilateral tubal |
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ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause |
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has practiced adequate contraception for 1 month prior to study intervention |
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administration, and |
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has a negative pregnancy test on the day of study intervention administration |
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and |
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has agreed to continue adequate contraception during the entire treatment period |
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and for 1 month after completion of the study intervention administration |
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Medical conditions
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Current or previous, confirmed or suspected disease caused by N. meningitidis
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Progressive, unstable or uncontrolled clinical conditions
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Abnormal function or modification of the immune system resulting from
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Prior/Concomitant therapy
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Prior/Concurrent clinical study experience
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Household contact with and/or intimate exposure to an individual with laboratory
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confirmed N. meningitidis infection within 60 days of enrolment
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Other exclusions
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Clinical conditions representing a contraindication to intramuscular vaccination and
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Pregnant or lactating female
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blood draws
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Are obese at enrolment (e.g. for participants from 20 years of age a body mass index
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(BMI) ≥ 30 kg/m2, for participants up to 19 years of age a BMI ≥ 95th percentile for
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Any study personnel or immediate dependents, family, or household member
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age and gender or as applicable per country recommendations)
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Any neuroinflammatory (including but not limited to: demyelinating disorders
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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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generalised tonic-clonic seizures, partial complex seizures, partial simple seizures)
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History of febrile convulsions should not lead to exclusion
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History of any reaction or hypersensitivity likely to be exacerbated by any component
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of the study interventions
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Hypersensitivity, including allergy, to any component of vaccines, including
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diphtheria toxoid (CRM197) and latex medicinal products or medical equipment whose use
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is foreseen in this study
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Autoimmune disorders (including, but not limited to: blood, endocrine, hepatic
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muscular, nervous system or skin autoimmune disorders; lupus erythematosus and
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associated conditions; rheumatoid arthritis and associated conditions
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scleroderma and associated disorders) or immunodeficiency syndromes (including
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but not limited to: acquired immunodeficiency syndromes and primary
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immunodeficiency syndromes)
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Systemic administration of corticosteroids (PO/IV/IM) for more than 14
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consecutive days within 3 months prior to study vaccination until the last blood
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sampling visit for Phase I and Phase II (Sourcing) and Visit 5 (Day 211) for
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Phase II (Formulation and Schedule-finding). This will mean prednisone equivalent
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≥20 mg/day for adult participants/ ≥0.5 mg/kg/day with maximum of 20 mg/day for
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paediatric participants. Inhaled and topical steroids are allowed
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Administration of antineoplastic and immunomodulating agents or radiotherapy
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within 90 days prior to study vaccination
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Administration of long-acting immune-modifying drugs at any time during the study
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period (e.g. infliximab)
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Any other clinical condition that, in the opinion of the investigator, might pose
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additional risk to the participant due to participation in the study
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Use of any investigational or non-registered product (drug, vaccine or medical device)
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other than the study intervention(s) during the period beginning 30 days before the
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first dose of study intervention(s) (Day -29 to Day 1), or their planned use during
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the study period
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Previous vaccination against any group B meningococcal vaccine at any time prior to
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informed consent and assent as applicable
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Administration of immunoglobulins and/or any blood products or plasma derivatives
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during the period starting 3 months before the administration of the first dose of
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study intervention(s) or planned administration until the last blood sampling visit
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for Phase I and Phase II (Sourcing) and Visit 5 (Day 211) for Phase II (Formulation
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and Schedule-finding)
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Chronic administration (defined as more than 14 days in total) of immunosuppressants
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or other immune-modifying drugs during the period starting 3 months prior to the first
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study intervention dose(s) until the last blood sampling visit for Phase I and Phase
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II (Sourcing) and Visit 5 (Day 211) for Phase II (Formulation and Schedule-finding)
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For corticosteroids, this will mean prednisone equivalent ≥20 mg/day for adult
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participants/ ≥0.5 mg/kg/day with maximum of 20 mg/day for paediatric participants
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Inhaled and topical steroids are allowed
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• Concurrently participating in another clinical study, at any time during the study
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period, in which the participant has been or will be exposed to an investigational or a
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non-investigational intervention (drug/invasive medical device)
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Female planning to become pregnant or planning to discontinue contraceptive
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precautions
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History of /current chronic alcohol abuse and/or drug abuse as determined by the
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investigator
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Phase II (Formulation and Schedule-finding): Child in care. Please refer to the
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Glossary of terms for the definition of child in care
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