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
Autor: | Eun Hee Chung, Jin Han Kang, Su Eun Park, Hyun Hee Kim, Soo Young Lee, Hui Sung Hwang, Sang Hyuk Ma, Jin Keun Chang, Fabrice Guitton, Esteban Ortiz, Jong Hyun Kim, Hyun Seung Lee |
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Rok vydání: | 2011 |
Předmět: |
Male
medicine.medical_specialty Diphtheria Toxoid Whooping Cough Immunization Secondary Antibodies Viral Diphtheria-Tetanus-acellular Pertussis Vaccines complex mixtures Internal medicine Republic of Korea Tetanus Toxoid medicine Humans Vaccines Combined Seroconversion Diphtheria-Tetanus-Pertussis Vaccine Immunization Schedule Pertussis Vaccine Tetanus General Veterinary General Immunology and Microbiology business.industry Diphtheria Immunogenicity Public Health Environmental and Occupational Health Toxoid Infant medicine.disease Antibodies Bacterial Vaccination Poliovirus Vaccine Inactivated Infectious Diseases Immunology Inactivated Poliovirus Vaccine Molecular Medicine Female business Poliomyelitis |
Zdroj: | Vaccine. 29:1551-1557 |
ISSN: | 0264-410X |
DOI: | 10.1016/j.vaccine.2010.12.094 |
Popis: | 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. |
Databáze: | OpenAIRE |
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