title: Safety and immunogenicity of two doses of quadrivalent meningococcal conjugate vaccine or one dose of meningococcal group C conjugate vaccine, both administered concomitantly with routine immunization to 12- to 18-month-old children.
abstract: OBJECTIVE
  To describe the immunogenicity and safety of a two-dose series of a quadrivalent meningococcal (serogroups A, C, Y and W) polysaccharide diphtheria toxoid conjugate vaccine (MenACYW-D) administered to toddlers.
  
  
  METHODS
  Children were randomly assigned (1:1) at study entry to receive MenACYW-D at 12 and 18 months of age (group 1; n=61) or meningococcal serogroup C conjugate vaccine (MCC) at 12 months of age (group 2; n=62). All received routine childhood immunizations. A, C, Y and W antibody titres were measured in group 1 before and one month after the 18-month MenACYW-D vaccination and were measured in group 2 at one and seven months post-MCC vaccination. Antibodies elicited by diphtheria and tetanus toxoids, and acellular pertussis vaccine adsorbed combined with inactivated poliomyelitis vaccine and Haemophilus influenzae b conjugate (DTaP-IPV-Hib) vaccine coadministered at the 18-month vaccination were measured one month later. Safety data were collected.
  
  
  RESULTS
  At 19 months of age, ≥96% in group 1 achieved protective titres for the four meningococcal serogroups after dose 2; 67% in group 2 exhibited protective titres against serogroup C 28 days after MCC vaccination at 12 months of age, declining to 27% seven months later. DTaP-IPV-Hib elicited high antibody concentrations/titres in groups 1 and 2, consistent with historical values. The safety profiles after each dose generated no unexpected safety signals; no serious adverse events were related to vaccination.
  
  
  CONCLUSIONS
  A two-dose series of MenACYW-D given concomitantly with a DTaP-IPV-Hib booster dose at 18 months of age demonstrated a good immunogenicity and safety profile. A two-dose series of MenACYW-D can be used as an alternative to one dose of MCC and provides protection against additional serogroups (NCT ID: NCT01359449).
authors.affiliation: Montreal Children's Hospital - McGill University Health Centre, Montreal, Quebec;
authors.forename: Francisco
authors.initials: F
authors.lastname: Noya
authors.affiliation: Montreal Children's Hospital - McGill University Health Centre, Montreal, Quebec;
authors.forename: Deirdre
authors.initials: D
authors.lastname: McCormack
authors.affiliation: Sanofi Pasteur Ltd, Toronto, Ontario;
authors.forename: Donna L
authors.initials: DL
authors.lastname: Reynolds
authors.affiliation: Sanofi Pasteur Ltd, Toronto, Ontario;
authors.forename: Dion
authors.initials: D
authors.lastname: Neame
authors.affiliation: Sanofi Pasteur, Lyon, France.
authors.forename: Philipp
authors.initials: P
authors.lastname: Oster
keywords: Canada; Conjugate; Meningococcal; Quadrivalent; Vaccine