{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,16]],"date-time":"2026-07-16T09:32:10Z","timestamp":1784194330419,"version":"3.55.0"},"reference-count":51,"publisher":"American Academy of Pediatrics (AAP)","issue":"1","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[1998,1,1]]},"abstract":"<jats:p>Background.\u2003The goal of the trial was to determine the efficacy of a multicomponent acellular pertussis vaccine against Bordetella illnesses in comparison with a whole-cell product and DT.<\/jats:p><jats:p>Design.\u2003In a randomized, double-blind fashion, 2- to 4-month-old infants received 4 doses of either DTP or DTaP vaccine at 3, 4.5, 6, and 15 to 18 months of age. The controls received 3 doses (3, 4.5, 15 to 18 months of age) of DT vaccine. The DTP vaccine was Lederle adsorbed vaccine (licensed in the United States) and DTaP was Lederle\/Takeda adsorbed vaccine. Follow-up for vaccine efficacy started 2 weeks after the third dose (DTP\/DTaP) and at the same age (6.5 months) in DT recipients. Reactogenicity of all doses of all three vaccines was documented by standardized parent diary cards. In addition, all subjects were monitored for respiratory illnesses and serious adverse events by biweekly phone calls.<\/jats:p><jats:p>Results.\u2003From May 1991 to January 1993, a total of 10\u2009271 infants were enrolled: 8532 received either DTP or DTaP and 1739 received DT. Specific efficacy against B pertussisinfections with cough \u22657 days duration was 83% (95% confidence interval [CI]: 76\u201388) and 72% (95% CI: 62\u201379) for DTP and DTaP, respectively; results for DTP and DTaP based on \u226521 days of cough with either paroxysms, whoop or posttussive vomiting (PWV) were 93% (95% CI: 89\u201396) and 83% (95% CI: 76\u201388), respectively. For DTaP vaccine, efficacy was higher after the fourth dose as compared with its efficacy after the third dose (78% vs 62% for cough \u22657 days and 85% vs 76% for cough \u226521 days with PWV). For DTP vaccine, efficacy was less varied after the third and fourth dose (78% vs 85% for cough \u22657 days and 93% vs 93% for cough \u226521 days with PWV). In contrast with DTP, the DTaP vaccine had some efficacy against B parapertussisinfection (point estimate for cough \u22657 days: 31% [95% CI: \u221210\u201356]). All vaccines were generally well-tolerated. However, side reactions were significantly less after DTaP compared with DTP.<\/jats:p><jats:p>Conclusions.\u2003Like other multicomponent acellular pertussis vaccines, the Lederle\/Takeda DTaP vaccine demonstrated good efficacy against mild and typical pertussis due to B pertussisinfections. Interestingly, it also may have some efficacy againstB parapertussis. Based on the results of this trial, the vaccine was licensed in the United States in December 1996 for all 5 doses of the currently recommended immunization schedule in this country.<\/jats:p>","DOI":"10.1542\/peds.101.1.1","type":"journal-article","created":{"date-parts":[[2004,8,13]],"date-time":"2004-08-13T23:44:32Z","timestamp":1092440672000},"page":"1-11","source":"Crossref","is-referenced-by-count":198,"title":["A Comparative Efficacy Trial in Germany in Infants Who Received Either the Lederle\/Takeda Acellular Pertussis Component DTP (DTaP) Vaccine, the Lederle Whole-Cell Component DTP Vaccine, or DT Vaccine"],"prefix":"10.1542","volume":"101","author":[{"given":"Klemens","family":"Stehr","sequence":"first","affiliation":[{"name":"From the Klinik mit Poliklinik fu\u0308r Kinder und Jugendliche der Friedrich-Alexander-Universita\u0308t Erlangen-Nu\u0308rnberg, Loschgestr. 15, D-91054 Erlangen, Germany; the"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James D.","family":"Cherry","sequence":"additional","affiliation":[{"name":"Department of Pediatrics and the UCLA Center for Vaccine Research, UCLA School of Medicine, Los Angeles, California;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ulrich","family":"Heininger","sequence":"additional","affiliation":[{"name":"From the Klinik mit Poliklinik fu\u0308r Kinder und Jugendliche der Friedrich-Alexander-Universita\u0308t Erlangen-Nu\u0308rnberg, Loschgestr. 15, D-91054 Erlangen, Germany; the"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sabina","family":"Schmitt-Grohe\u0301","sequence":"additional","affiliation":[{"name":"From the Klinik mit Poliklinik fu\u0308r Kinder und Jugendliche der Friedrich-Alexander-Universita\u0308t Erlangen-Nu\u0308rnberg, Loschgestr. 15, D-91054 Erlangen, Germany; the"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"U\u0308berall","sequence":"additional","affiliation":[{"name":"From the Klinik mit Poliklinik fu\u0308r Kinder und Jugendliche der Friedrich-Alexander-Universita\u0308t Erlangen-Nu\u0308rnberg, Loschgestr. 15, D-91054 Erlangen, Germany; the"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suzanne","family":"Laussucq","sequence":"additional","affiliation":[{"name":"Wyeth-Lederle Vaccines and Pediatrics, Pearl River, New York; the"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Eckhardt","sequence":"additional","affiliation":[{"name":"Wyeth-Lederle Vaccines and Pediatrics, Pearl River, New York; the"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Meyer","sequence":"additional","affiliation":[{"name":"Institut fu\u0308r Medizinische Statistik der Friedrich-Alexander-Universita\u0308t Erlangen-Nu\u0308rnberg, Waldstrasse, D-91054 Erlangen, Germany; and the"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rita","family":"Engelhardt","sequence":"additional","affiliation":[{"name":"Department of Biomathematics, UCLA School of Medicine, Los Angeles, California."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Christenson","sequence":"additional","affiliation":[{"name":"Department of Pediatrics and the UCLA Center for Vaccine Research, UCLA School of Medicine, Los Angeles, California;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"the Pertussis Vaccine Study Group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"417","published-online":{"date-parts":[[1998,1,1]]},"reference":[{"key":"2021120904473971300_B1"},{"key":"2021120904473971300_B2","first-page":"872","article-title":"A double-blind study comparing an acellular pertussis-component DTP vaccine with a whole-cell pertussis-component DTP vaccine in 18-month-old children.","volume":"140","author":"Lewis","year":"1986","journal-title":"Am J Dis Child."},{"key":"2021120904473971300_B3","doi-asserted-by":"crossref","first-page":"867","DOI":"10.1001\/archpedi.1986.02140230037024","article-title":"Diphtheria, tetanus, and pertussis vaccine. 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(English translation: Reactogenicity and immunogenicity of pertussis immunization with a 4-component acellular vaccine (Lederle\/Takeda) in 185 adults.)","volume":"34","author":"Stehr","year":"1995","journal-title":"Pa\u0308diatr Grenzgeb."},{"key":"2021120904473971300_B13","doi-asserted-by":"crossref","first-page":"53","DOI":"10.1001\/jama.1993.03500010063032","article-title":"Adult immunization with acellular pertussis vaccine.","volume":"269","author":"Edwards","year":"1993","journal-title":"JAMA."},{"key":"2021120904473971300_B14","doi-asserted-by":"crossref","first-page":"734","DOI":"10.1001\/archpedi.1991.02160070030017","article-title":"A comparative trial of the reactogenicity and immunogenicity of Takeda acellular pertussis vaccine combined with tetanus and diphtheria toxoids.","volume":"145","author":"Kimura","year":"1991","journal-title":"Am J Dis Child."},{"key":"2021120904473971300_B15","first-page":"1141","article-title":"Immunogenicity and reactogenicity of Takeda acellular pertussis-component diphtheria-tetanus-pertussis vaccine in two and three month old children in Japan.","volume":"146","author":"Kamiya","year":"1992","journal-title":"Am J Dis Child."},{"key":"2021120904473971300_B16","doi-asserted-by":"crossref","first-page":"81","DOI":"10.1016\/0264-410X(94)90014-0","article-title":"Comparative study of Lederle\/Takeda acellular and whole-cell pertussis component diphtheria-tetanus-pertussis vaccines in infants in Germany.","volume":"12","author":"Heininger","year":"1994","journal-title":"Vaccine."},{"key":"2021120904473971300_B17","doi-asserted-by":"crossref","first-page":"530","DOI":"10.1097\/00006454-199207000-00005","article-title":"Safety and immunogenicity of acellular pertussis vaccine combined with diphtheria and tetanus toxoids in 17- to 24-month-old children.","volume":"11","author":"Glode","year":"1992","journal-title":"Pediatr Infect Dis 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case definitions.","volume":"145","author":"Blackwelder","year":"1991","journal-title":"Am J Dis Child."},{"key":"2021120904473971300_B34","first-page":"58","article-title":"A comparative efficacy trial in Germany in which infants received either the Lederle\/Takeda acellular pertussis component DTP (DTaP) vaccine, the Lederle whole-cell component DTP (DTP) vaccine or DT vaccine.","volume":"89","author":"Stehr","year":"1997","journal-title":"Develop Biol Standard."},{"key":"2021120904473971300_B35"},{"key":"2021120904473971300_B36","first-page":"113","article-title":"Minor adverse events in a comparative efficacy trial in Germany in infants who received either the Lederle\/Takeda acellular pertussis component DTP (DTaP) vaccine, the Lederle whole-cell component DTP (DTP) or DT vaccine.","volume":"89","author":"Schmitt-Grohe\u0301","year":"1997","journal-title":"Develop Biol Standard."},{"key":"2021120904473971300_B37","first-page":"83","article-title":"Severe adverse events in a comparative efficacy trial in Germany in infants receiving either the Lederle\/Takeda acellular pertussis component DTP (DTaP) vaccine, the Lederle whole-cell component DTP (DTP) or DT vaccine.","volume":"89","author":"U\u0308berall","year":"1997","journal-title":"Develop Biol Standard."},{"key":"2021120904473971300_B38","doi-asserted-by":"crossref","first-page":"349","DOI":"10.1056\/NEJM199602083340602","article-title":"A controlled trial of a two-component acellular, a five-component acellular and a whole-cell pertussis vaccine.","volume":"334","author":"Gustafsson","year":"1996","journal-title":"N Engl J Med."},{"key":"2021120904473971300_B39","doi-asserted-by":"crossref","first-page":"1045","DOI":"10.1056\/NEJM199510193331604","article-title":"A placebo-controlled trial of a pertussis-toxoid vaccine.","volume":"333","author":"Trollfors","year":"1995","journal-title":"N Engl J 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