Clinical Study of Meningococcal ACYWX Conjugate Vaccine, in 12-16 Month Olds

Exclusion Criteria

• •History of any meningococcal vaccine administration.
• •Current or previous, confirmed or suspected disease caused by N. meningitidis.
• •Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis infection within 60 days of enrolment.
• •History of severe allergic reactions after previous vaccinations or hypersensitivity to any study vaccine component including tetanus, diphtheria and diphtheria toxoid (CRM197).
• •Acute or chronic, clinically significant pulmonary, cardiovascular, metabolic, neurological, hepatic, or renal functional abnormality, as determined by medical history or physical examination.
• •Any confirmed or suspected condition with impaired/altered function of immune system (immunodeficient or autoimmune conditions).
• •Have any bleeding disorder which is considered as a contraindication to intramuscular injection or blood draw.
• •Severe acute malnutrition.
• •A family history of congenital or hereditary immunodeficiency.
• •History of either hepatitis B or hepatitis C virus infection or human immunodeficiency virus infection.
• •Major congenital defects.
• •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the study vaccination or planned use throughout the study period. (For corticosteroids, this means prednisone, or equivalent, ≥ 0.5 mg/kg per day. Inhaled, intranasal and topical steroids are allowed).
• •Administration of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 3 months or planned use throughout the study period.
• •Administration of any vaccine within 28 days prior to enrolment in the study or planned administration of any vaccine within 14 days before or after any study vaccination.
• •Use of any investigational or non-registered drug or vaccine within 30 days prior to the administration of study vaccines or planned during the study.
• •Malaria infection as confirmed by a Rapid Diagnostic Test.
• •Individuals who are close family members of individuals conducting this study.
• •Have experienced a moderate or severe acute infection and/or fever (defined as temperature ≥ 37.5°C) within 3 days prior to enrolment.
• •Have received systemic antibiotic treatment within 3 days prior to enrolment.
• •Non-residence in the study area or intent to move out within six months.
• •Any condition which, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study