safety, tolerability, and immunogenicity of menabcwy administered on different dosing schedules in healthy adolescents

Conditions: Meningitis, Meningococcal

Summary: the purpose of this study is to assess the safety, tolerability, and immunogenicity of the combined meningococcal groups a, b, c, w and y (menabcwy) vaccine (gsk3536819a) intended to protect against invasive meningococcal disease (imd) caused by all 5 meningococcal serogroups.


Eligibility criteria:
inclusion criteria: * participants 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. * 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) prior to performing any study specific procedure. * a male or female between, and including, 11 and 14 years of age (i.e. 14 years + 364 days) at the time of the first vaccination. * healthy participants as established by medical history, physical examination and clinical judgment of the investigator before entering into the study. * female participants of non-childbearing potential may be enrolled in the study. non-childbearing potential is defined as pre-menarche, hysterectomy, bilateral-salpingectomy or bilateral ovariectomy. * female participants of childbearing potential may be enrolled in the study, if the participant: * has practiced adequate contraception for 30 days prior to first vaccination, and * has a negative pregnancy test\* on the day of vaccination, and * has agreed to follow adequate contraception for 30 days before each of the 2 subsequent vaccinations and for 30 days after each vaccination \* urine samples for pregnancy testing will be collected from female participants of childbearing potential at visit 1, visit 3 and visit 5 prior to the vaccination. exclusion criteria: medical conditions * current or previous, confirmed or suspected disease caused by n. meningitidis. * household contact with and/or intimate exposure to an individual with laboratory confirmed n. meningitidis infection within 60 days of enrolment. * progressive, unstable or uncontrolled clinical conditions. * clinical conditions representing a contraindication to intramuscular vaccination and blood draws. * any neuroinflammatory, congenital neurological conditions, encephalopathies, seizures. history of febrile convulsions should not lead to exclusion. * history of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s)/product(s). * hypersensitivity, including allergy, to any component of vaccines, including diphtheria toxoid (crm197) and latex medicinal products or medical equipment whose use is foreseen in this study. * abnormal function or modification of the immune system resulting from: * autoimmune disorders or immunodeficiency syndromes. * systemic administration of corticosteroids (po/iv/im) for more than 14 consecutive days within 90 days prior to study vaccination. this will mean prednisone equivalent ≥20 mg/day for adult participants / ≥0.5 mg/kg/day with maximum 20 mg/day for paediatric 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. * any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study. prior/concomitant therapy * use of any investigational or non-registered product (drug, vaccine or medical device) other than the study vaccine(s)/product(s) during the period starting 30 days before the first dose of study vaccine(s)/product(s) (day -29 to day 1), or planned use during the study period. * previous vaccination with any meningococcal (menb or menacwy) vaccine at any time prior to informed consent/ assent (as applicable) with the exception of meningococcal c (conjugated or polysaccharide) vaccination, if the last dose of menc was received at ≤24 months of age. * administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the administration of study vaccine/product or planned administration before the next blood sampling visit. * chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the first vaccine/product dose(s). for corticosteroids, this will mean prednisone equivalent ≥20 mg/day for adult participants / ≥0.5 mg/kg/day with maximum of 20 mg/day for paediatric participants. inhaled and topical steroids are allowed. prior/concurrent clinical study experience • 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). other exclusions * child in care. * pregnant or lactating female. * female planning to become pregnant / planning to discontinue contraceptive precautions during the windows reported in the inclusion criterion. * history of /current chronic alcohol abuse and/or drug abuse as determined by the investigator. * any study personnel or immediate dependants, family, or household members.

Keywords: menabcwy safety tolerability immunogenicity healthy adolescents invasive meningococcal disease