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 |
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Authors: | Lee Soo Young Hwang Hui Sung Kim Jong Hyun Kim Hyun Hee Lee Hyun Seung Chung Eun Hee Park Su Eun Ma Sang Hyuk Chang Jin Keun Guitton Fabrice Ortiz Esteban Kang Jin Han |
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Institution: | a Incheon St. Mary's Hospital, The Catholic University of Korea, Incheon, Republic of Korea b St. Vincent's Hospital, The Catholic University of Korea, Suwon, Republic of Korea c Bucheon St. Mary's Hospital, The Catholic University of Korea, Bucheon, Republic of Korea d Euijeongbu St. Mary's Hospital, The Catholic University of Korea, Euijeongbu, Republic of Korea e Dankook University Hospital, Choongnam, Republic of Korea f Pusan National University Hospital, Pusan, Republic of Korea g Changwon Fatima Hospital, Kyungnam, Republic of Korea h Hanil Medical Center, Seoul, Republic of Korea i Sanofi Pasteur, Lyon, France j Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea |
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Abstract: | 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 (≥8 1/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. |
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Keywords: | Vaccines Combined Diphtheria-Tetanus-acellular pertussis vaccines Poliovirus vaccine Inactivated |
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