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

This is an interventional prevention trial for Meningitis, Meningococcal focused on measuring Neisseria meningitidis, conjugate meningococcal vaccine, meningococcal serogroup X Read More

Inclusion Criteria:

• Male and female children between 12 months and 16 months old inclusive (minimum 365 days of age and maximum 16 months plus 29 days of age);
• For whom parent(s)/legal guardian(s) have given written informed consent after the nature of the study has been explained according to local regulatory requirements;
• Who the investigator believes that their parent(s)/ guardian(s) will be available for all the subject visits and would comply with the requirements of the protocol (e.g., timely reporting of adverse events, availability for study site visits and home visits);
• Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
• Individuals who completed their local infant EPI schedule through 9 months of age (except MenAfriVac dose). A birth dose of OPV is not required)

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