A Phase IIIB, Randomized, Observer-blind, Multicenter Study to Assess the Safety and Immunogenicity of GSK's Meningococcal Group B Vaccine When Administered Concomitantly With GSK's Meningococcal MenACWY Conjugate Vaccine to Healthy Subjects of 16-18 Years of Age

205419

The purpose of this study is to evaluate the immunogenicity, safety and tolerability of rMenB+OMV NZ and MenACWY vaccines when concomitantly administered to healthy subjects 16-18 years of age.

2020-08-25

2023-11-21

2024-07-21

Active (not recruiting)

Early phase I

943

Inclusion Criteria: * 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. * 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. * 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. * 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. * A male or female between, and including, 16 and 18 years of age at the time of the first vaccination. * Healthy subjects as established by medical history and clinical examination before entering into the study. * 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. * Female subjects of childbearing potential may be enrolled in the study, if the subject: * 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 treatment period and for 2 months after completion of the vaccination series. Exclusion Criteria: Medical conditions * Progressive, unstable or uncontrolled clinical conditions. * Clinical conditions representing a contraindication to intramuscular vaccination and blood draws. * Abnormal function of the immune system resulting from: * Clinical conditions. * 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 paediatric subjects, or equivalent. Inhaled and topical steroids are allowed. * Administration of antineoplastic or immunomodulating agents or radiotherapy within 90 days prior to informed consent. * Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines. * History of any reaction or hypersensitivity likely to be exacerbated by any medicinal products or medical equipment whose use is foreseen in this study. * Current or previous, confirmed or suspected disease caused by N. meningitidis. * Known contact to an individual with any laboratory-confirmed N. meningitidis infection within 60 days, prior to enrolment. * History of neuroinflammatory or autoimmune condition. * Recurrent history or un-controlled neurological disorders or seizures. Prior/Concomitant therapy * 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. * 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. * Previous vaccination with any group B meningococcal vaccine at any time prior to informed consent and assent as applicable. * Previous vaccination with 2 doses of quadrivalent meningococcal conjugate vaccine (MenACWY, Menveo, Menactra or MenQuadfi). Prior/Concurrent clinical study experience • 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. Other exclusions * Child in care. * Pregnant or lactating female. * Female planning to become pregnant or planning to discontinue contraceptive precautions. * Any study personnel or immediate dependents, family, or household member.

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2024-03-29