Immunogenicity and safety of a combined diphtheria, tetanus, acellular pertussis, and inactivated poliovirus vaccine (DTaP-IPV) compared to separate administration of standalone DTaP and IPV vaccines: a randomized, controlled study in infants in the Republic of Korea.
Author(s): Lee SY, Hwang HS, Kim JH, Kim HH, Lee HS, Chung EH, Park SE, Ma SH, Chang JK, Guitton F, Ortiz E, Kang JH
Affiliation(s): Incheon St. Mary's Hospital, The Catholic University of Korea, Incheon, Republic of Korea.
Publication date & source: 2011-02-11, Vaccine., 29(8):1551-7. Epub 2011 Jan 6.
Publication type: Comparative Study; Multicenter Study; Randomized Controlled Trial
This randomized trial enrolled 442 infants in the Republic of Korea to assess the immunogenicity and safety of a combined diphtheria, tetanus, acellular pertussis, and inactivated poliovirus vaccine (DTaP-IPV; Tetraxim) for primary vaccination at 2, 4 and 6 months of age compared with DTaP and IPV vaccines given separately. Immunogenicity was high in both groups; seroprotection and seroconversion rates of the combined vaccine (Group A) were non-inferior to the control vaccines (Group B). All subjects were seroprotected against poliovirus types 1, 2 and 3 (>/= 81/dil) and anti-diphtheria (>/= 0.01 IU/mL); 99.0% were seroprotected against tetanus (>/= 0.1 IU/mL). At least 93.6% had anti-diphtheria antibody titers >/= 0.1 IU/mL. Anti-pertussis toxoid (PT) and anti-filamentous haemagglutinin (FHA) seroconversion (>/= 4-fold increase in antibody titer) rates were 96.6% and 94.4% for Group A, 92.2% and 78.4% for Group B. Most solicited reactions occurred within 4 days of vaccination, resolved within 3 days and were mild. Severe solicited reactions occurred after </= 0.5% of doses in Group A and </= 0.9% in Group B. No withdrawals occurred because of adverse events. The DTaP-IPV combined vaccine given at 2, 4, and 6 months of age was well tolerated; immunogenicity was similar to the control vaccines. Copyright (c) 2011 Elsevier Ltd. All rights reserved.