A Study on the Safety, Tolerability and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Infants

GlaxoSmithKline (GSK)

Status and phase: Active, not recruiting; Phase 2

Conditions: Infections, Meningococcal

Treatments: Combination Product: MenABCWY-2Gen low dose vaccine; Combination Product: MenABCWY-2Gen high dose vaccine; Combination Product: MenABCWY-1Gen vaccine; Combination Product: MenACWY-TT vaccine; Combination Product: MenB vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT05082285

2021-001367-24 (EudraCT Number)

217043

Details and patient eligibility

About

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-2Gen) vaccine intended to protect against invasive meningococcal disease (IMD) caused by all 5 meningococcal serogroups, in healthy infants 2 months of age (MoA) at enrolment.

Enrollment: 724 patients

Sex: All

Ages: 55 to 89 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 parent(s)/LAR(s) of the participant prior to performance of any study specific procedure.
• Healthy participants as established by medical history and clinical examination before entering into the study.
• A male or female between, and including, 55 and 89 days of age (approximately 2 MoA) at the time of the first study vaccination.
• Born after a gestation period of ≥37 weeks, with a birth weight ≥2.5 kg.

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 from birth.
• Progressive, unstable or uncontrolled clinical conditions.
• Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
• Any neuroinflammatory disorders, congenital and peripartum neurological conditions, encephalopathies, seizures.
• Congenital or peripartum disorders resulting in a chronic condition
• Major congenital defects, as assessed by the investigator.
• 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 starting from birth until Visit 5. This will mean prednisone equivalent ≥0.5 mg/kg/day with maximum 20 mg/day. Inhaled and topical steroids are allowed.
• Administration of antineoplastic and immunomodulating agents or radiotherapy from birth.
• 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 vaccines from birth, or planned use during the study period.
• Previous vaccination with any meningococcal vaccine.
• Administration of immunoglobulins and/or any blood products or plasma derivatives from birth or planned administration during the study period until Visit 5.
• Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting from birth until Visit 5. For corticosteroids, this will mean prednisone equivalent ≥0.5 mg/kg/day with maximum 20 mg/day. 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.
• Study personnel as an immediate family or household member.
• For contraindications to administering routine vaccines foreseen in the study, refer to their approved product label/package insert.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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724 participants in 4 patient groups

ABCWY-2Gen low dose Group

Experimental group

Description:

Participants receive 3 doses of the MenABCWY-2Gen low dose vaccine.

Treatment:

Combination Product: MenABCWY-2Gen low dose vaccine

MenB+MenACWY-TT Group

Active Comparator group

Description:

Participants receive 3 doses of both the meningococcal group B (MenB) vaccine and the meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine.

Treatment:

Combination Product: MenB vaccine

Combination Product: MenACWY-TT vaccine

ABCWY-2Gen high dose Group

Experimental group

Description:

Participants receive 3 doses of the MenABCWY-2Gen high dose vaccine in.

Treatment:

Combination Product: MenABCWY-2Gen high dose vaccine

ABCWY-1Gen Group

Experimental group

Description:

Participants receive 3 doses of the MenABCWY-1Gen vaccine.

Treatment:

Combination Product: MenABCWY-1Gen vaccine