A Study on the Immune Response and Safety of a Vaccine Against N. Meningitidis Serogroup B Infection in Healthy Infants From 2 Months of Age

Inclusion Criteria:

• Participant's parent(s)/Legally acceptable representative(s) [LAR(s)], who, in theopinion of the investigator, can and will comply with the requirements of theprotocol (e.g., return for follow-up visits).

• Written or witnessed/thumb printed informed consent obtained from theparent(s)/LAR(s) of the participant prior to performance of any study specificprocedure.

• Healthy participants as established by medical history and clinical examinationbefore entering the study.

• Born full term (i.e., after a gestation period of ≥37 weeks).

Exclusion Criteria:

• Current or previous, confirmed or suspected disease caused by N. meningitidis.

• Known exposure from birth to an individual with laboratory confirmed N. meningitidisinfection.

• Progressive, unstable or uncontrolled clinical conditions.

• Any contraindications to group B meningococcal vaccine, including but not limitedto: history of any reaction or hypersensitivity likely to be exacerbated by anycomponent of the study intervention.

• Medical conditions representing a contraindication to intramuscular vaccination andblood draws.

• Any neuroinflammatory condition (including but not limited to: demyelinatingdisorders, encephalitis or myelitis of any origin), any congenital neurologicalcondition, encephalopathies, seizures (including all subtypes such as: absenceseizures, generalized tonic-clonic seizures, partial complex seizures, partialsimple seizures).

• Congenital or peripartum disorders resulting in a chronic illness (including but notlimited to: chromosomal abnormalities, cerebral palsy, metabolism or synthesisdisorders, cardiac disorders).

• Other serious chronic illness.

• Hypersensitivity to latex.

• Abnormal function of the immune system resulting from clinical conditions, oradministration of antineoplastic and immunomodulating agents or radiotherapy for anyduration from birth or autoimmune disorders (including, but not limited to: blood,endocrine, hepatic, muscular, nervous system or skin autoimmune disorders) orimmunodeficiency syndromes (including, but not limited to: acquired immunodeficiencysyndromes and primary immunodeficiency syndromes).

• Any other clinical condition that, in the opinion of the investigator, might poseadditional risk to the participant due to participation in the study.

Prior/Concomitant Therapy:

• Use of any investigational or non-registered product (drug, vaccine or medicaldevice) since birth, or their planned use during the study period.

• Previous vaccination with any group B meningococcal vaccine at any time prior toinformed consent.

• Administration of long acting (defined as administered once per week or lessfrequently) immunosuppressants, including monoclonal antibodies (e.g., infliximab)since birth and/or planned use at any time during the study period.

• Chronic administration of immune-modifying drugs (defined as more than 14consecutive days in total) since birth and/or planned use of long-actingimmune-modifying treatments at any time during the study period. Forcorticosteroids, this will mean prednisone equivalent 0.5 mg/kg/day. Inhaled andtopical steroids are allowed.

• Administration of immunoglobulins and/or any blood products or plasma derivativessince birth and/or planned use at any time during the study period.

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/invasive medical device).

Other Exclusion Criteria

• Child in care.

• Any immediate dependents, family, or household member of study personnel.