a phase 3 study to assess the immune response and safety of rmenb+omv nz in primed healthy participants (10 to 20 years old)

Conditions: Meningitis

Summary: the main purpose of this study is to evaluate the immune response and safety of a booster dose of the meningococcal group b vaccine, rmenb+omv nz (also known as bexsero), in adolescents and young adults aged 10 to 20 years. this study focuses on individuals who were first vaccinated with rmenb+omv nz as infants. the primary hypothesis is that a booster dose of the vaccine will elicit a stronger immune response in these primed individuals compared to those who have never received any group b meningococcal vaccine, referred to as 'nave' participants.


Eligibility criteria:
inclusion criteria: participants are eligible to be included in the study only if all of the following criteria apply: for primed group only: • participated who were primed with rmenb + omv nz in only either 3+1 or 2+1 schedule during the first 2 years of life as confirmed by electronic or paper vaccination record. or for naïve group only: • electronic or paper vaccination record confirmed participant who has never received any group b meningococcal vaccine and is recruited in the same country as primed participants. for all participants: * participants and/or 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) along with informed consent from the participant's parent(s)/lar(s) prior to performing any study specific procedure. note: for age 10-16 years, parents or lar to give consent along with participants, based on country regulations for participants and for \>16/18 to 20 years, participants give consent independent of parents/lars. * a male or female between, and including, 10 and 20 years of age at the time of the first study intervention administration. * 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. * female participants of childbearing potential may be enrolled in the study, if the participant: * has practiced adequate contraception for 1 month prior to study intervention administration, and * has a negative pregnancy test on the day of study intervention administration, and * has agreed to continue adequate contraception during the entire study treatment period. exclusion criteria: participants are excluded from the study if any of the following criteria apply: medical conditions * current or previous, confirmed or suspected disease caused by n. meningitidis. * known exposure to an individual with laboratory confirmed n. meningitidis infection, within 60 days prior to enrollment. * history of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention. * medical conditions representing a contraindication to intramuscular vaccination and blood draws. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). * 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 intervention during the period beginning 30 days before the first dose of study intervention (day -29 to day 1), or their planned use during the study period. * chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune-modifying treatments at any time up to the end of the study. * within 90 days prior to study intervention administration: for corticosteroids, this will mean prednisone equivalent ≥20 mg/day for adult participants or \>= 0.5 mg/kg/day with maximum of 20 milligram (mg)/day for pediatric participants. inhaled and topical steroids are allowed. * within 90 days prior to study intervention administration: long-acting immune-modifying drugs including among others immunotherapy (e.g., tnf-inhibitors), monoclonal antibodies, antitumoral medication. * administration of immunoglobulins and/or any blood products or plasma derivatives within 180 days prior to study intervention administration and/or planned use at any time up to the end of the study. for primed group only: • participants who received additional dose(s) of group b meningococcal vaccine other than 2+1 or 3+1 schedule prior to study intervention administration. 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 intervention (drug/vaccine/invasive medical device). other exclusion criteria * pregnant or lactating female participant. * any study personnel or their immediate dependents, family, or household member. * child in care.

Keywords: meningitis booster dose bexsero immune response