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

Conditions: Infections, Meningococcal

Summary: 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.


Eligibility criteria:
inclusion criteria: * 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. * 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 participant/parent(s)/lar(s) of the participant prior to performance of any study specific procedure. * 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. * a male or female between, and including, 16 and 18 years of age at the time of the first vaccination. * healthy participants as established by medical history and clinical examination before entering the study. * 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. * 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 * 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 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. * any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant 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 • 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.

Keywords: meningitis invasive meningococcal disease bexsero menveo