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
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.
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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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- 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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- 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.
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- Administration of antineoplastic or immunomodulating agents or radiotherapy within 90 days prior to informed consent.
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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.
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, 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
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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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- Invasive meningococcal disease
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