title: Antibody Persistence in Young Children 5 Years after Vaccination with a Combined Haemophilus influenzae Type b-Neisseria meningitidis Serogroup C Conjugate Vaccine Coadministered with Diphtheria-Tetanus-Acellular Pertussis-Based and Pneumococcal Conjugate Vaccines.
abstract: We evaluated antibody persistence in children up to 5 years after administration of a combined Haemophilus influenzae type b (Hib)-Neisseria meningitidis serogroup C (MenC)-tetanus toxoid (TT) conjugate vaccine coadministered with a pneumococcal conjugate vaccine. This is the follow-up study of a randomized trial (ClinicalTrials.gov registration no. NCT00334334/00463437) in which healthy children were vaccinated (primary vaccinations at 2, 4, and 6 months of age and booster vaccination at 11 to 18 months of age) with Hib-MenC-TT or a control MenC conjugate vaccine, coadministered with diphtheria-tetanus-acellular pertussis (DTPa)-based combination vaccines (DTPa/Hib for control groups) and a pneumococcal conjugate vaccine (10-valent pneumococcal nontypeable H. influenzae protein D conjugate vaccine [PHiD-CV] or 7-valent cross-reacting material 197 [CRM197] conjugate vaccine [7vCRM]). MenC antibody titers were measured with a serum bactericidal antibody (SBA) assay using rabbit complement (i.e., rabbit SBA [rSBA]), and antibodies against Hib polyribosylribitol phosphate (PRP) were measured with an enzyme-linked immunosorbent assay. Antibody persistence up to 5 years after booster vaccination is reported for 530 children ∼6 years of age. The percentages of children with seroprotective rSBA-MenC titers were between 24.2% and 40.1% in all groups approximately 5 years after booster vaccination. More than 98.5% of children in each group retained seroprotective anti-PRP concentrations. No vaccine-related serious adverse events and no events related to a lack of vaccine efficacy were reported. Approximately 5 years after booster vaccination, the majority of children retained seroprotective anti-PRP antibody concentrations. The percentage of children retaining seroprotective rSBA-MenC titers was low (≤40%), suggesting that a significant proportion of children may be unprotected against MenC disease. (This study has been registered at ClinicalTrials.gov under registration no. NCT00891176.).
authors.affiliation: Unidad Neonatal, Hospital Universitario de Móstoles, Madrid, Spain.
authors.forename: Juan Carlos
authors.initials: JC
authors.lastname: Tejedor
authors.affiliation: Pediatrics Department, Zespol Opieki Zdrowotnej w Debicy, Debica, Poland.
authors.forename: Jerzy
authors.initials: J
authors.lastname: Brzostek
authors.affiliation: Neuroinfection and Pediatric Neurology, John Paul II Hospital, Cracow, Poland.
authors.forename: Ryszard
authors.initials: R
authors.lastname: Konior
authors.affiliation: Praxis, Nordlingen, Germany.
authors.forename: Detlef
authors.initials: D
authors.lastname: Grunert
authors.affiliation: GSK Vaccines, Bangalore, India.
authors.forename: Devayani
authors.initials: D
authors.lastname: Kolhe
authors.affiliation: GSK Vaccines, King of Prussia, Pennsylvania, USA.
authors.forename: Yaela
authors.initials: Y
authors.lastname: Baine
authors.affiliation: GSK Vaccines, Wavre, Belgium marie.x.van-der-wielen@gsk.com.
authors.forename: Marie
authors.initials: M
authors.lastname: Van Der Wielen
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood*; D001770:Blood Bactericidal Activity; D002648:Child; D002675:Child, Preschool; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines / Q000008:administration & dosage*; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D005500:Follow-Up Studies; D018073:Haemophilus Vaccines / Q000008:administration & dosage* / Q000276:immunology*; D000069443:Heptavalent Pneumococcal Conjugate Vaccine / Q000008:administration & dosage*; D006801:Humans; D007223:Infant; D008297:Male; D038542:Neisseria meningitidis, Serogroup C / Q000276:immunology*; D022242:Pneumococcal Vaccines / Q000008:administration & dosage*; D016032:Randomized Controlled Trials as Topic; D013745:Tetanus Toxoid / Q000008:administration & dosage* / Q000276:immunology*; D018074:Vaccines, Conjugate / Q000008:administration & dosage / Q000276:immunology
chemical_list: C586648:10-valent pneumococcal conjugate vaccine; D000907:Antibodies, Bacterial; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D018073:Haemophilus Vaccines; D000069443:Heptavalent Pneumococcal Conjugate Vaccine; C527605:Hib-MenCY-TT vaccine; D022242:Pneumococcal Vaccines; D013745:Tetanus Toxoid; D018074:Vaccines, Conjugate