A Combined Haemophilus influenzae Type B Neisseria meningitidis Serogroup C Tetanus Toxoid Conjugate Vaccine Is Immunogenic and Well-tolerated When Coadministered With Diphtheria, Tetanus, Acellular Pertussis Hepatitis B-inactivated Poliovirus at 3, 5 and 11 Months of Age: Results of an Open, Randomized, Controlled Study

作者：Vesikari Timo^*; Forsten Aino; Desole Maria Guiseppina; Ferrera Giuseppe; Caubet Magalie; Mesaros Narcisa; Boutriau Dominique

来源：Pediatric Infectious Disease Journal, 2013, 32(5): 521-529.

DOI：10.1097/INF.0b013e31827e22e3

• conjugate vaccine
• Haemophilus influenzae type B
• immunization schedule
• infants
• Neisseria meningitidis serogroup C

Background: This study evaluated the immunogenicity, reactogenicity and safety of the combined Haemophilus influenzae type B Neisseria meningitidis serogroup C tetanus toxoid conjugate vaccine (Hib-MenC-TT) coad-ministered with diphtheria, tetanus, acellular pertussis hepatitis B-inactivated poliovirus (DTPa-HBV-IPV) as 2 primary and 1 booster doses at 3, 5 and 11 months of age. %26lt;br%26gt;Methods: In this phase II open study (NCT00327184), 709 infants were randomized in 2 parallel groups (1: 1) to receive either Hib-MenC-TT coadministered with DTPa-HBV-IPV or control vaccines (MenC-TT coadministered with DTPa-HBV-IPV/Hib). Serum bactericidal activity for MenC (rSBA-MenC) and antibody concentrations against polyribosylribitol phosphate from Hib (anti-PRP) and hepatitis B (anti-HBs) were measured at 1 month after dose 2, before booster and 1 month after booster dose. Solicited (local/general) and unsolicited symptoms were assessed up to 4 and 31 days, respectively, after each vaccination. Serious adverse events were recorded throughout the study. %26lt;br%26gt;Results: One month after dose 2, high percentages of infants in both groups had rSBA-MenC titers %26gt;= 8 (%26gt;= 99.1%), anti-PRP concentrations %26gt;= 0.15 mu g/mL(%26gt;= 96.5%) and anti-HBs concentrations %26gt;= 10 mIU/mL (%26gt;= 95.3%), which persisted up to the booster vaccination (%26gt;= 94.5%, %26gt;= 86.1%, %26gt;= 94.2%) and increased again after the booster dose (100%, 100%, %26gt;= 99%). Exploratory analyses indicated that rSBA-MenC geometric mean titers were lower and anti-PRP geometric mean concentrations were higher in the infants vaccinated with Hib-MenC-TT compared with the control vaccines at all time points. The safety profiles of the coadministered vaccines were similar in both groups. %26lt;br%26gt;Conclusions: The Hib-MenC-TT and DTPa-HBV-IPV vaccines are immunogenic with a clinically acceptable safety profile when coadministered as 2 primary doses during infancy and 1 booster dose at 11 months of age.

• 出版日期2013-5