Meningococcal Serogroup ACYWX Conjugate Vaccine in Comparison With MenACWY-TT Conjugate Vaccine

Inclusion Criteria

• Male and female children between 9 months and 11 months old inclusive.
• Parent(s)/legal guardian(s) have provided written informed consent, after the nature of the study has been explained according to local regulatory requirements.
• The investigator believes that their parent(s)/guardian(s) will be available for all the subjects visits and will comply with the requirements of the protocol (e.g., timely reporting of adverse events).
• Individual is in good health as determined by medical history, physical examination, and clinical judgement of the investigator.
• Individual has completed their local infant EPI vaccines, not including 9-month EPI vaccines (at the 9-month visit) or 15- month EPI vaccines (at the 15-month visit). A birth dose of oral polio vaccine is not required.

Exclusion Criteria

• History of receipt of any meningococcal vaccine.
• Has received a measles-containing vaccine.
• Current or previous, confirm 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 or study vaccination (for the 15-month age group).
• History of severe allergic reactions after previous vaccinations or hypersensitivity to any study vaccine component including tetanus, diphtheria and mutant 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 or altered function of the immune system (e.g., immunodeficiency, autoimmune conditions, malnutrition).
• Have any bleeding disorder which is considered a contraindication to intramuscular injection or blood draw.
• Severe acute malnutrition. Note: a weight-for-length Z-score of less than -3 satisfies this exclusion criteria.
• History of either hepatitis B or hepatitis C virus infection, human immunodeficiency virus infection, or hereditary immunodeficiency.
• Presence of major and clinically significant 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 14 days prior to enrolment in the study or planned administration of any vaccine within 14 days before or after study vaccination.
• Use of any investigational or non-registered drug or vaccine within 28 days prior to the administration of study vaccine or planned during the study.
• Malaria infection as confirmed by a Rapid Diagnostic Test. Note: subjects positive at screening may be treated for malaria as per national guidelines outside of the study, and if the subject remains eligible, vaccinated no earlier than 5 days after completing treatment.
• Individuals who are close family member* of individuals conducting this study. *defined as a child with direct genetic relationship to a member of the study team.
• Have experienced a moderate or severe acute infection and/or fever (defined as temperature ≥ 37.5°C) within 3 days prior to enrolment or study vaccination.
• Have received systemic antibiotic treatment within 3 days prior to enrolment or study vaccination.
• Non-residence in the study area or intent to move out within six months.
• Any condition which, in the opinion of the investigator, might post additional risk to the subject due to participation in the study.