A Phase IIb, Randomized, Observer-Blind study to Describe the Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents

Phase 1

Conditions: Meningitis, Meningococcal
MedDRA version: 20.0Level: PTClassification code: 10027249Term: Meningitis meningococcal Class: 100000004862
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

Registration Number: CTIS2023-504301-37-00

Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 300

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 (e.g. completion of the eDiaries, return for follow-up visits and is available for telephone calls)., 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 judgement 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

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 (including but not limited to: demyelinating disorders, encephalitis or myelitis of any origin), congenital neurological conditions, encephalopathies, seizures (including all subtypes such as: absence seizures, generalised tonic-clonic seizures, partial complex seizures, partial simple 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 (including, but not limited to: blood, endocrine, hepatic, muscular, nervous system or skin autoimmune disorders; lupus erythematosus and associated conditions; rheumatoid arthritis and associated conditions; scleroderma and associated disorders) or immunodeficiency syndromes (including, but not limited to: acquired immunodeficiency syndromes and primary 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 (e.g. infliximab)., Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.