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

• Immunogenicity: To provide information concerning the immune response of a tetravalent meningococcal diphtheria conjugate vaccine. [ Time Frame: 28 days post vaccination ] [ Designated as safety issue: No ]
• Safety: To provide information concerning the safety after administration of a tetravalent meningococcal diphtheria conjugate vaccine. [ Time Frame: 28 days post-vaccination ] [ Designated as safety issue: Yes ]

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 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 HIB conjugate vaccine 28 days following vaccination.

• Meningitis
• Meningococcemia

• Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
  0.5 mL, Intramuscular
  Other Name: Menactra®
• Biological: Haemophilus Influenzae Type b (Hib) vaccine
  0.5 mL, Intramuscular
  Other Name: Hiberix®

• Experimental: Menactra® Vaccine Group
  Participants receiving the tetravalent (A, C, Y, and W 135) meningococcal diphtheria toxoid conjugate vaccine
  Intervention: Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
• Active Comparator: Hiberix® Vaccine Group
  Participants receiving Haemophilus Influenzae Type b (Hib) vaccine
  Intervention: Biological: Haemophilus Influenzae Type b (Hib) vaccine

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.