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Executive Summary

NORTH AMERICAN VACCINE U.S. PHASE II TRIAL OF DTaP-IPV COMBO vaccine is slated to begin in the third or fourth quarter of 1993 and to run for about two years, the Beltsville, Md. firm announced Aug. 20. The trial will be conducted on about 200 infants 2, 4, 6 or 18 months old in a Boston hospital. North American Vaccine's subsidiary Amvax is responsible for the development of the firm's DTaP and DTaP-IPV vaccines. The combination vaccine DTaP-IPV, with diphtheria, tetanus, acellular pertussis, and enhanced inactivated polio components, is currently in a Phase III trial being conducted in Denmark under the Statens Seruminstitut, an enterprise owned by the Danish government. That trial, begun in the second quarter of this year, is expected to include about 200 infants and be completed in 1994. "There is a growing consensus in the U.S. that the standard polio vaccine regimen should include both IPV [inactivated polio virus vaccine] and OPV [oral live polio vaccine]," North American Vaccine President Sharon Mates, MD, asserted. Mates noted that "in the U.S., although IPV is recognized as both safe and effective in preventing polio disease, the current practice is to orally administer a live polio virus vaccine. However, oral polio virus vaccination has been associated with a small...risk of paralytic polio." She suggested that "the substitution of IPV, for at least the first immunizing doses, might reduce the number of cases of OPV-associated polo." The Phase II trial will test a number of vaccine schedules that will begin with administration of the DTaP-IPV vaccine and then switch over to DTaP with OPV. North American Vaccine "believes that a vaccination program utilizing DTaP-IPV may become generally accepted for a number of the doses in the vaccination schedule because the vaccination schedules for diphtheria, tetanus, pertussis, and polio are highly compatible," Mates said. North American Vaccine holds exclusive U.S. and U.K. licenses to Statens Seruminstitut's IPV, as well as diphtheria components, which the institute supplies to North American Vaccine for its trials. The National Institute of Child Health and Human Development currently is conducting a Phase III trial of North American Vaccine's DTaP vaccine in Sweden ("The Pink Sheet" June 22, 1992, p. 9). Vaccinations, which have been completed, were performed on 3,500 infants, about half of whom received DTaP and half DT alone. NICHD will begin a U.S. trial of the firm's DTaP, to include about 3,000 infants, "very shortly," North American Vaccine said. In addition, the firm is developing a multivalent vaccine combining DTaP toxoids with a vaccine for the prevention of meningitis caused by Haemophilus b influenza (DTaP-HIB) and a vaccine that adds IPV to these components (DRaP-IPV-HIB). North American Vaccine plans to add the HIB component to its immunization of an undetermined number of infants in its DTaP-IPV trial in Denmark next year.

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