a study on the safety, tolerability and immune response of meningococcal combined abcwy vaccine in healthy infants

Conditions: Infections, Meningococcal

Summary: 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.


Eligibility criteria:
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.

Keywords: menabcwy-2gen menabcwy-1gen bexsero nimenrix safety tolerability immunogenicity invasive meningococcal disease healthy infants