Safety and Immunogenicity Evaluation After One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants and Toddlers
Safety and Immunogenicity Evaluation After One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants and Toddlers
The primary immunogenicity objective is to assess and compare the immunogenicity of one dose
 of MenACWY to one dose of Menjugate given to healthy toddlers at 12 months of age as measured
 by the percentage of subjects with serum bactericidal titers directed against N. meningitidis
 serogroup C ≥ 1:8 obtained in the serum bactericidal assay using human complement (hSBA).
Inclusion Criteria:

 -  infants 6 to 8 months old inclusive, who were born after full term pregnancy and
 previously received three doses of both Prevenar and Infanrix-hexa vaccines at least
 30 days before study entry

 Exclusion Criteria:

 -  who previously received any meningococcal vaccine;

 -  who have had a previous confirmed or suspected disease caused by N. meningitidis, C.
 diphtheriae, C. tetani, Poliovirus, Hepatitis B, Hib, Pneumococcus or B. pertussis;

 -  who have had household contact with and/or intimate exposure to an individual with
 laboratory confirmed N. meningitidis (serogroups A, C, W135, or Y), B. pertussis, Hib,
 C. diphtheriae, Polio, or pneumococcal infection at any time since birth;

 -  Subjects with any serious, acute or chronic progressive disease