Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
10968973 | Vaccine | 2011 | 7 Pages |
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; Tetraximâ¢) 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 (â¥8 1/dil) and anti-diphtheria (â¥0.01 IU/mL); 99.0% were seroprotected against tetanus (â¥0.1 IU/mL). At least 93.6% had anti-diphtheria antibody titers â¥0.1 IU/mL. Anti-pertussis toxoid (PT) and anti-filamentous haemagglutinin (FHA) seroconversion (â¥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 â¤0.5% of doses in Group A and â¤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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Authors
Soo Young Lee, Hui Sung Hwang, Jong Hyun Kim, Hyun Hee Kim, Hyun Seung Lee, Eun Hee Chung, Su Eun Park, Sang Hyuk Ma, Jin Keun Chang, Fabrice Guitton, Esteban Ortiz, Jin Han Kang,