New meningitis vaccine shows promise for infants in phase 3 trial

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male and female children between 9 months and 11 months old inclusive. 2. Parent(s)/legal guardian(s) have provided written informed consent, after the nature of the study has been explained according to local regulatory requirements. 3. 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). 4. Individual is in good health as determined by medical history, physical examination, and clinical judgement of the investigator. 5. 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: 1. History of receipt of any meningococcal vaccine. 2. Has received a measles-containing vaccine. 3. Current or previous, confirm or suspected disease caused by N. meningitidis. 4. 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). 5. History of severe allergic reactions after previous vaccinations or hypersensitivity to any study vaccine component including tetanus, diphtheria and mutant diphtheria toxoid (CRM197). 6. Acute or chronic, clinically significant pulmonary, cardiovascular, metabolic, neurological, hepatic, or renal functional abnormality, as determined by medical history or physical examination. 7. Any confirmed or suspected condition with impaired or altered function of the immune system (e.g., immunodeficiency, autoimmune conditions, malnutrition). 8. Have any bleeding disorder which is considered a contraindication to intramuscular injection or blood draw. 9. Severe acute malnutrition. Note: a weight-for-length Z-score of less than -3 satisfies this exclusion criteria. 10. History of either hepatitis B or hepatitis C virus infection, human immunodeficiency virus infection, or hereditary immunodeficiency. 11. Presence of major and clinically significant congenital defects. 12. 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). 13. 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. 14. 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. 15. 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. 16. 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. 17. 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. 18. 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. 19. Have received systemic antibiotic treatment within 3 days prior to enrolment or study vaccination. 20. Non-residence in the study area or intent to move out within six months. 21. Any condition which, in the opinion of the investigator, might post additional risk to the subject due to participation in the study.