Meningococcal Serogroup ACYWX Conjugate Vaccine in Comparison With MenACWY-TT Conjugate Vaccine
Meningitis
About this trial
This is an interventional prevention trial for Meningitis focused on measuring vaccine, meningococcal, Neisseria meningitidis, conjugate meningococcal vaccine, meningococcal serogroup X
Eligibility Criteria
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, β₯ 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 β₯ 37.5Β°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.
Sites / Locations
- Centre pour le Developpement des Vaccins du Mali
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Active Comparator
Experimental
Active Comparator
Vaccination at 9 months of age with NmCV-5
Vaccination at 9 months of age with MenACWY-TT
Vaccination at 15 months of age with NmCV-5
Vaccination at 15 months of age with MenACWY-TT
Infant participants randomized to receive the NmCV-5 meningococcal vaccination at 9 months of age, while receiving the current Mali EPI schedule of vaccines.
Infant participants randomized to receive the MenACWY-TT meningococcal vaccination at 9 months of age, while receiving the current Mali EPI schedule of vaccines.
Infant participants randomized to receive the NmCV-5 meningococcal vaccination at 15 months of age, while receiving the current Mali EPI schedule of vaccines.
Infant participants randomized to receive the MenACWY-TT meningococcal vaccination at 15 months of age, while receiving the current Mali EPI schedule of vaccines.