Study to Assess the Safety and Immunogenicity of GSK Meningococcal Group B Vaccine When Administered Concomitantly With GSK Meningococcal MenACWY Conjugate Vaccine in Healthy Subjects of 16-18 Years of Age
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol or/and participants' 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 participant/parent(s)/LAR(s) of the participant prior to performance of any study specific procedure.
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Written informed assent obtained from the participant (if applicable) along with informed consent from the participant'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 participants as established by medical history and clinical examination before entering 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 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 treatment period and for 2 months after completion of the vaccination series.
Exclusion criteria
Medical conditions
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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:
- 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 participants) or ≥ 0.5 mg/kg/day or 20 mg/day whichever is the maximum dose for pediatric participants, or equivalent. Inhaled and topical steroids are allowed.
- 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 participant 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
- 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
• Participant 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, 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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
945 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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