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Pediatr Infect Dis J. 2016 Nov 22. [Epub ahead of print]
Safety and Immunogenicity of DTaP5-IPV Compared With DTaP5 Plus IPV as the Fifth Dose in Children 4 to 6 Years of Age.
Smith MJ1 Jordanov E Sheng X Tsang PH.
Abstract
BACKGROUND:
Immunogenicity and safety of stand-alone diphtheria tetanus toxoid 5-component acellular pertussis vaccine adsorbed inactivated poliovirus (IPV) combination vaccine (DTaP5-IPV) was compared with separate DTaP5 plus IPV vaccines as fifth dose in children 4-6 years of age.
METHODS:
In this phase III controlled multicenter randomized open-label study participants were randomized to DTaP5-IPV plus measles/mumps/rubella (MMR) and varicella virus (VZV) vaccines (Group 1; N=324) DTaP5+IPV with MMR and VZV (Group 2; N=327) DTaP5-IPV with/without MMR/VZV (Group 3; N=2419) or DTaP5+IPV with/without MMR/VZV (Group 4; N=302). Immunogenicity endpoints (Groups 1 and 2) included booster response rates and antibody geometric mean concentrations (GMCs). Non-inferiority of DTaP5-IPV to DTaP5+IPV was evaluated based on differences (Groups 1 and 2) in booster rates and post-vaccination GMC ratios (GMCR). Safety endpoints (all Groups) included all adverse events (AEs).
RESULTS:
Non-inferiority of DTaP5-IPV compared with DTaP5+IPV for all antigens was achieved. Booster rate differences were 5.4% for pertussis toxoid (PT); 7.4% for filamentous hemagglutinin (FHA); 3.7% for pertactin (PT); 4.8% for fimbriae types 2 and 3 (FIM); -0.1% for tetanus; -1.9% for diphtheria; 3.7% for poliovirus 1; -0.7% for poliovirus 2; and 0.3% for poliovirus 3. GMCRs were 1.97 for PT; 1.56 for FHA; 1.51 for PT; 1.33 for FIM; 1.17 for tetanus; 1.20 for diphtheria; 1.27 for poliovirus 1; 0.90 for poliovirus 2; and 1.34 for poliovirus 3. Rates of immediate and unsolicited AEs solicited injection site reactions and systemic reactions were similar between groups.
CONCLUSIONS:
DTaP5-IPV was safe and immunogenic in children 4-6 years of age.