North American Vaccine announced Friday that it has filed aninvestigational new drug application (IND) with FDA for aPhase II clinical trial in the U.S. of a vaccine that combines thecompany's acellular pertussis toxoid with diphtheria andtetanus toxoid and an injectable enhanced inactivated poliovaccine.
North American Vaccine (ASE:NVX) of Beltsville, Md., said thepurpose of the trial is to establish the safety and immugenicityof its DTaP-IPV vaccine. The company's vaccine will be testedagainst the current standard immunization practice ofproviding DTP (whole cell) vaccine together with oraladministration of a live polio virus vaccine (OPV).
The trial of infants at 2, 4, 6 and 18 months of age, to beconducted at a hospital in Boston, will also investigate differentimmunization series of the DTaP-IPV injections followed byOPV administration.
The company expects the trial to begin in the third or fourthquarter of this year and to run about two years.
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