Study of Antibody Responses After a Dose of Tetravalent Meningococcal Diphtheria Conjugate Vaccine in Children

Antibody Responses for Serogroup C After One Dose of an Experimental Tetravalent (A, C, Y, and W-135) Meningococcal Diphtheria Toxoid Conjugate Vaccine Versus a Non-meningococcal Control Vaccine in Children Who Have Previously Received a Monovalent Meningococcal C Conjugate Vaccine

The study investigated safety profile and the antibody responses to an experimental tetravalent meningococcal diphtheria conjugate vaccine (Menactra®) in children who have received a monovalent meningococcal C conjugate vaccine at least one year previously.

Primary objective:

To describe and compare the Serum Bactericidal Assay (SBA) antibody response for serogroup C in participants receiving Menactra® to the serogroup C antibody response in a control group of participants receiving a licensed Haemophilus Influenzae Type b (Hib) conjugate vaccine 28 days following vaccination.

Inclusion Criteria :

• Participant is healthy, as determined by medical history and physical examination.
• Participant is 2 years to < 5 years of age at the time of vaccination.
• At least one year from primary vaccination with a monovalent meningococcal C conjugate vaccine has elapsed.
• Parent/Guardian has signed an Ethics Committee-approved informed consent form. A culturally appropriate translation will be used for non-English speaking participants where required.

Exclusion Criteria :

• Serious chronic disease (i.e. cardiac, renal, neurologic, metabolic, rheumatologic, etc.)
• Known or suspected impairment of immunologic function
• Acute medical illness with or without fever within the last 72 hours or an axillary temperature ≥ 37.5ºC at the time of inclusion
• History of documented invasive meningococcal disease
• Administration of immune globulin, other blood products within the last three months, injected or oral corticosteroids or other immunomodulatory therapy within six weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting < 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrolment
• Antibiotic therapy within the 72 hours prior to vaccination or 72 hours prior to drawing any blood sample
• Received any vaccine in the 28-day period prior to enrolment, or scheduled to receive any vaccine during enrolment in the trial
• Received a meningococcal C conjugate vaccine within one year prior to enrolment
• Suspected or known hypersensitivity to any of the vaccine components
• Unavailable for the entire study period or unable to attend the scheduled visits or to comply with the study procedures
• Enrolled in another clinical trial
• Any condition, which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.