Immunogenicity and Safety Study of GSK's MenABCWY Vaccine in Healthy Adolescents and Adults Previously Primed With MenACWY Vaccine

Launched by GLAXOSMITHKLINE · Jan 11, 2021

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Eligibility criteria

• Inclusion Criteria:
• • 1. 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).
• • 2. 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.
• • 3. Written or witnessed/thumb printed informed assent obtained from participants below the legal age of consent prior to performance of any study specific procedure.
• • 4. 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.
• • 5. 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.
• • 6. Healthy participants as established by medical history, physical examination, and clinical judgment of the investigator before entering into the study.
• • 7. 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.
• 8. Female participants of childbearing potential may be enrolled in the study, if the participant:
• • has practiced adequate contraception for 30 days prior to vaccination, and
• • has a negative pregnancy test\* on the day of vaccination, and
• • has agreed to continue adequate contraception during the entire intervention period and for 30 days after completion of the vaccination series.
• Exclusion Criteria:
• • 1. Current or previous, confirmed or suspected disease caused by N. meningitidis.
• • 2. Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection within 60 days of enrollment.
• • 3. History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s)/product.
• • 4. 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.
• • 5. Progressive, unstable or uncontrolled clinical conditions
• • 6. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
• 7. Abnormal function or modification of the immune system resulting from:
• • 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).
• • 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.
• • Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to study vaccination.
• • Administration of long-acting immune-modifying drugs at any time during the study period (e.g., infliximab).
• • 8. Any neuroinflammatory (including but not limited to: demyelinating disorders, encephalitis or myelitis of any origin), congenital neurological conditions, encephalopathies, seizures (including all subtypes such as: absence seizures, generalized tonic-clonic seizures, partial complex seizures, partial simple seizures). History of febrile convulsions should not lead to exclusion.
• • 9. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
• • 10. 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.
• • 11. 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).
• • 12. Previous vaccination with 2 or more doses of MenACWY vaccine.
• • 13. 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.
• • 14. 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.
• • 15. 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).
• • 16. Child in care.
• • 17. Pregnant or lactating female.
• • 18. Female planning to become pregnant or planning to discontinue contraceptive precautions.
• • 19. History of/current chronic alcohol and/or drug abuse.
• • 20. Involvement in the study as a study staff member or being immediate dependents, family, or household member of a study staff member.