摘要

Introduction: This follow-up study assessed the 5-year persistence of vaccine-induced antibodies (Td-IPV or DT-IPV) and the immune response to a booster dose of DTaP-IPV. Methods: This was an open-label, parallel-group (two arms), multicentre trial performed at 44 study sites in France. Children aged 11-13 years, of either sex, who received Td-IPV (Revaxis (R)) and DT-IPV (DT Polio (R)) vaccines at 6 years of age in one previous open-label trial with no further vaccination against diphtheria, tetanus, pertussis or poliomyelitis, were enrolled. All participants received a single intramuscular booster dose (0.5 mL) of DTaP-IPV vaccine (Tetravac-Acellulaire (R)). Study endpoints were based on antibody persistence and post-booster immune responses. Safety was monitored throughout the study. Descriptive statistics were used for all analyses. Results: Of the 758 children included in the previous study, 274 were included in this follow-up study; 129 had previously been vaccinated with Td-IPV, and 145 had previously received DT-IPV. At least 96.5% of participants in both groups presented an anti-diphtheria and anti-tetanus concentration >= 0.01 IU/mL, and anti-poliovirus types 1-3 titres >= 8 (1/dilution). Following vaccination with DTaP-IPV, anti-diphtheria and anti-tetanus antibody concentrations >= 0.1 IU/mL and anti-poliovirus types 1-3 antibody titres >= 8 (1/dilution) were achieved in all participants. DTaP-IPV was well tolerated in this study. There were no serious adverse events during the study, and no participant withdrew because of adverse events. Discussion: The present study confirmed the long-term immunity conferred by Td-IPV when given as a booster dose, and supports the use of Td-IPV as a second booster at 6 years of age in children previously vaccinated against diphtheria, tetanus and poliomyelitis types 1-3.

  • 出版日期2015-7-31