Journal Article

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

Hwang, Hui Sung, Kim, Jong Hyun, Lee, Soo Young, Ma, Sang Hyuk, Guitton, Fabrice, Kang, Jin Han, Ortiz, Esteban, Park, Su Eun, Chung, Eun Hee, Kim, Hyun Hee, Lee, Hyun Seung, Chang, Jin Keun

2011

Overview

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 (≥0.01IU/mL); 99.0% were seroprotected against tetanus (≥0.1IU/mL). At least 93.6% had anti-diphtheria antibody titers ≥0.1IU/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.

• Publisher: Elsevier Ltd,Elsevier,Elsevier Limited
• Subject: Age / Allergy and Immunology / Antibodies, Bacterial - blood / Antibodies, Viral - blood / Applied microbiology / Bacterial diseases / Biological and medical sciences / Biomedical research / Combined / Diphtheria / Diphtheria - prevention & control / Diphtheria Toxoid - administration & dosage / Diphtheria Toxoid - adverse effects / Diphtheria Toxoid - immunology / Diphtheria-Tetanus-acellular Pertussis Vaccines - administration & dosage / Diphtheria-Tetanus-acellular Pertussis Vaccines - adverse effects / Diphtheria-Tetanus-acellular Pertussis Vaccines - immunology / Diphtheria-Tetanus-Pertussis Vaccine - administration & dosage / Diphtheria-Tetanus-Pertussis Vaccine - adverse effects / Diphtheria-Tetanus-Pertussis Vaccine - immunology / Diphtheria–Tetanus–acellular pertussis vaccines / Ent and stomatologic bacterial diseases / Female / Fever / Fundamental and applied biological sciences. Psychology / hemagglutinins / Hemophilia / Hepatitis / Human bacterial diseases / Humans / immune response / Immunization Schedule / Immunization, Secondary / Immunogenicity / Inactivated / Infant / Infants / Infectious diseases / Licenses / Male / Medical sciences / Microbiology / Miscellaneous / Mumps / Pertussis Vaccine - administration & dosage / Pertussis Vaccine - adverse effects / Pertussis Vaccine - immunology / Poliomyelitis / Poliomyelitis - prevention & control / Poliovirus vaccine / Poliovirus Vaccine, Inactivated - administration & dosage / Poliovirus Vaccine, Inactivated - adverse effects / Poliovirus Vaccine, Inactivated - immunology / Public health / Republic of Korea / seroconversion / South Korea / Tetanus / Tetanus - prevention & control / Tetanus Toxoid - administration & dosage / Tetanus Toxoid - adverse effects / Tetanus Toxoid - immunology / vaccination / Vaccines / Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects) / Vaccines, Combined - administration & dosage / Vaccines, Combined - adverse effects / Vaccines, Combined - immunology / Virology / Whooping Cough - prevention & control