title: Single priming dose of meningococcal group C conjugate vaccine (NeisVac-C®) in infants.
abstract: Since the introduction of the meningococcal C conjugate (MCC) vaccine in the pediatric population in 1999, numerous clinical studies have confirmed the immunogenicity and safety of the NeisVac-C(®) vaccine, and several have observed a strong immune response after a single priming dose, which could be successfully boosted. Maximizing protection of infants with as few vaccine doses as possible would increase the general acceptability of the immunization strategies and support broader coverage without increasing vaccination costs. This was a randomized feasibility study of a single priming NeisVac-C(®) vaccine dose administered at 4 or 6 months of age, compared to the currently licensed two dose priming at 2 and 4 months of age, followed by a booster vaccination at 12-13 months of age. High seroprotection rates and serum bactericidal antibody (rSBA) titers were observed in all study groups, whether a single or two dose priming vaccination was administered, at all time points investigated: one month after the priming vaccination(s) (>99% of subjects rSBA≥8), prior to booster vaccination (>65% of subjects with rSBA≥8, with the lowest titers and GMTs seen in the two dose priming group), as well as after booster vaccination administration (99% with rSBA≥128 in all three study groups, with the highest GMT of 2472 seen in the 4 month single dose group). This study confirmed trends seen in previous reports that a single-dose priming vaccination at 4 or 6 months of age can be considered a valuable alternative to the currently licensed two-dose priming vaccination schedule.
authors.affiliation: Global R&D, Baxter BioScience, Industriestrasse 67, A-1220 Vienna, Austria.
authors.forename: Eva-Maria
authors.initials: EM
authors.lastname: Poellabauer
authors.forename: Borislava G
authors.initials: BG
authors.lastname: Pavlova
authors.forename: Sandor
authors.initials: S
authors.lastname: Fritsch
authors.forename: Julia
authors.initials: J
authors.lastname: Singer
authors.forename: Christian
authors.initials: C
authors.lastname: Neubauer
authors.forename: Jennifer
authors.initials: J
authors.lastname: Doralt
authors.forename: Barbara
authors.initials: B
authors.lastname: Valenta-Singer
authors.forename: Hartmut J
authors.initials: HJ
authors.lastname: Ehrlich
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood*; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage; D005240:Feasibility Studies; D005260:Female; D018073:Haemophilus Vaccines / Q000008:administration & dosage; D017325:Hepatitis B Vaccines / Q000008:administration & dosage; D006801:Humans; D007117:Immunization, Secondary; D007223:Infant; D008297:Male; D008585:Meningitis, Meningococcal / Q000276:immunology / Q000517:prevention & control*; D022401:Meningococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D009345:Neisseria meningitidis / Q000276:immunology; D022242:Pneumococcal Vaccines / Q000008:administration & dosage; D011044:Poland; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage; D013030:Spain; D014611:Vaccination; D017778:Vaccines, Combined / Q000008:administration & dosage; D018074:Vaccines, Conjugate / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: C538862:13-valent pneumococcal vaccine; D000907:Antibodies, Bacterial; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; D017325:Hepatitis B Vaccines; D022401:Meningococcal Vaccines; D022242:Pneumococcal Vaccines; D011054:Poliovirus Vaccine, Inactivated; D017778:Vaccines, Combined; D018074:Vaccines, Conjugate; C541235:diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine; C410218:serogroup C meningococcal conjugate vaccine
keywords: AE; CI; Dose; GCP; GMT; ICH; IU; International Conference on Harmonization; MCC; Meningococcal C conjugate vaccine; TT; Tetanus toxoid; Vaccine administration; WHO; World Health Organization; adverse event; confidence interval; geometric mean titer; good clinical practice; international unit; meningococcal C conjugate vaccine; rSBA; serum bactericidal activity (using rabbit complement); tetanus toxoid