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PEDIATRICS Vol. 101 No. 1 January 1998, pp. 1-11
Received Jul 16, 1997; accepted Sep 18, 1997.
,
,, and
From the * Klinik mit Poliklinik für Kinder und
Jugendliche der Friedrich-Alexander-Universität
Erlangen-Nürnberg, Loschgestr. 15, D-91054 Erlangen, Germany;
the Department of Pediatrics and the UCLA Center for Vaccine
Research, UCLA School of Medicine, Los Angeles, California;
§ Wyeth-Lederle Vaccines and Pediatrics, Pearl River, New York; the
Institut für Medizinische Statistik der
Friedrich-Alexander-Universität Erlangen-Nürnberg,
Waldstrasse, D-91054 Erlangen, Germany; and the ¶ Department of
Biomathematics, UCLA School of Medicine, Los Angeles, California.
Background. The 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.
Design. In 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.
Results. From May 1991 to January 1993, a total of
10 271 infants were enrolled: 8532 received either DTP or DTaP and
1739 received DT. Specific efficacy against B pertussis
infections with cough 
7 days duration was 83% (95% confidence
interval [CI]: 76-88) and 72% (95% CI: 62-79) for DTP and DTaP,
respectively; results for DTP and DTaP based on 21 days of cough with
either paroxysms, whoop or posttussive vomiting (PWV) were 93% (95%
CI: 89-96) and 83% (95% CI: 76-88), 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 7 days and 85% vs 76%
for cough 21 days with PWV). For DTP vaccine, efficacy was less
varied after the third and fourth dose (78% vs 85% for cough 7 days
and 93% vs 93% for cough 21 days with PWV). In contrast with DTP,
the DTaP vaccine had some efficacy against B parapertussis
infection (point estimate for cough 7 days: 31% [95% CI:
10-56]). All vaccines were generally well-tolerated. However, side
reactions were significantly less after DTaP compared with DTP.
Conclusions. Like other multicomponent acellular pertussis vaccines, the Lederle/Takeda DTaP vaccine demonstrated good efficacy against mild and typical pertussis due to B pertussis infections. Interestingly, it also may have some efficacy against B 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.
Key words: acellular pertussis vaccine, whole-cell pertussis vaccine, double blind, B pertussis, B parapertussis.
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