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NORTH AMERICAN VACCINE ANNOUNCES INTENTION TO CONDUCT A PHASE II CLINICAL TRIAL FOR COMBINATION VACCINE

 BELTSVILLE, Md., Aug. 20 /PRNewswire/ -- North American Vaccine (AMEX: NVX) announced today that it is planning to conduct a Phase II clinical trial in the United States with a combination vaccine which combines the company's acellular pertussis toxoid with diphtheria and tetanus toxoid and an injectable enhanced inactivated polio vaccine (DTaP-IPV). The purpose of the clinical trial is to establish the safety and immunogenicity of this vaccine.
 The company filed an investigational new drug application (IND) with the U.S. Food and Drug Administration to test the DTaP-IPV vaccine against the current standards immunization practice of providing DTP (whole cell) vaccine together with oral administration of a live polio virus vaccine (OPV). The clinical trial, which will include infants at 2, 4, 6 and 18 months of age, will also investigate different immunization series of the DTaP-IPV injections followed by OPV administration. The clinical trial, to be conducted at a hospital in Boston, is expected to begin in the third or fourth quarter of 1993 and will run for approximately two years.
 Dr. Sharon Mates, president of North American Vaccine, stated: "The company is pleased to announce the filing of the IND for this Phase II clinical trial in the United States for the combined DTaP-IPV vaccine. The company 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. In the United States, 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 poliovirus vaccination has been associated with a small but devastating risk of paralytic polio. Accordingly, the substitution of IPV, for at least the first immunizing doses, might reduce the number of cases of OPV-associated polio. Moreover, there is a growing consensus in the United States that the standard polio vaccine regimen should include both IPV and OPV.
 "This clinical trial further advances the strategy of the company to develop combination vaccines. In addition to the DTaP-IPV, the company is developing other combination vaccines. Earlier this year, the company announced progress in the development of a multivalent vaccine for the prevention of diphtheria, tetanus, pertussis, and meningitis caused by Haemophilus influenza type b (DTaP-HIB) and a multivalent vaccine which combines the DTaP-HIB with a polio vaccine (DTaP-IPV-HIB). The company believes that simultaneous administration of combination vaccines in the form of a single injectable vaccine will reduce the number of injections required to obtain protection against multiple diseases, will result in less trauma and pain for the child and parents, will reduce the number of required visits to the physician thereby reducing costs, and may facilitate compliance with recommended immunization programs."
 North American Vaccine, Inc., both directly and through its subsidiaries, is engaged in the research, development and production of vaccines to prevent human infectious diseases.
 -0- 8/20/93
 /CONTACT: Sharon Mates, Ph.D., president, North American Vaccine, Inc., 301-470-6100/
 (NVX)


CO: North American Vaccine, Inc. ST: Maryland IN: MTC SU:

DC-IH -- DC002 -- 4608 08/20/93 08:33 EDT
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Publication:PR Newswire
Date:Aug 20, 1993
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