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

This is an interventional prevention trial for Infections, Meningococcal focused on measuring MenABCWY-2Gen, MenABCWY-1Gen, Bexsero, Nimenrix, Safety, Tolerability, Immunogenicity, Invasive Meningococcal Disease, Healthy infants Read More

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.