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CONNAUGHT LABORATORIES, INC. RECEIVES ACELLULAR DTP VACCINE LICENSE

CONNAUGHT LABORATORIES, INC. RECEIVES ACELLULAR DTP VACCINE LICENSE
 SWIFTWATER, Pa., Aug. 26 /PRNewswire/ -- The Food and Drug Administration has issued a license for a new vaccine against diphtheria, tetanus and pertussis (DTP) manufactured by Connaught Laboratories, Inc. (CLI) of Swiftwater, Pa. The new vaccine, Tripedia(TM), Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, is produced using purified, inactivated components of the pertussis bacterial organism instead of whole cells. This new vaccine reduces the incidence of redness, swelling and tenderness compared with a whole-cell pertussis DTP vaccine, also produced by the company. The pertussis component of this new vaccine induces immunity against whooping cough, which is highly communicable and can cause severe disease.
 The American Academy of Pediatrics (AAP) recommends that children routinely receive a five-dose vaccination series against these diseases before age seven. The first three doses, recommended at two, four and six months of age, require the whole-cell pertussis DTP vaccine. The fourth dose is administered at approximately 18 months of age, and the pre-school fifth dose at 4-6 years of age. Tripedia is approved for children as young as 15 months of age who have previously received 3 or 4 doses of whole-cell pertussis DTP vaccine.
 It is anticipated that Tripedia will be available before year end, but initial supplies will be somewhat limited.
 Composition of Tripedia
 The acellular pertussis component of the Tripedia vaccine consists of pertussis toxoid and filamentous hemagglutinin antigens. These two antigens produce immunologic protection against pertussis. The pertussis component is supplied by The Research Foundation for Microbial Diseases of Osaka University (BIKEN(R)) and is added to the diphtheria and tetanus components produced by CLI.
 Efficacy Trials
 The only completed, large, randomized, double-blind, placebo- controlled efficacy trial with an acellular pertussis vaccine was carried out in Sweden in 1986-1987. The trial studied the efficacy of a two component BIKEN acellular vaccine, composed of pertussis toxoid and filamentous hemagglutinin, similar to that contained in Tripedia vaccine. In the first phase, the trial was a randomized, blinded prospective trial using a standardized case definition and active case ascertainment. In this phase, 1,389 children 5 to 11 months of age, received two doses of the BIKEN inactivated pertussis toxin and filamentous hemagglutinin (PT and FHA) acellular pertussis vaccine 7 to 13 weeks apart and 954 children received a placebo control. Results were observed during the first 15 months of follow-up from 30 days after the second dose.
 A four-year unblinded passive follow-up of vaccine and placebo recipients from the above Swedish study has shown a post-trial efficacy of 77 percent (95 percent confidence interval; 64 percent to 85 percent) for all culture-proven cases of pertussis and an efficacy of 92 percent (95 percent confidence interval; 83 percent to 96 percent) for culture- proven cases with a cough of over 30 days duration.
 Anti-PT and anti-FHA antibody responses in children enrolled in the trial in Sweden were subsequently compared to responses observed in clinical trials of Tripedia conducted in the U.S. In the U.S. trials, children 15 to 20 months of age who had previously received three doses of licensed whole-cell pertussis DTP and children 4 to 6 years of age who had previously received four doses of licensed whole-cell pertussis DTP were immunized with a single dose of Tripedia. The anti-PT and anti-FHA antibody responses to Tripedia in the U.S. trials were found to be similar to the responses observed in children enrolled in the trial in Sweden.
 Additionally, the antibody responses in children immunized with Tripedia were compared to those in children immunized with CLI's licensed whole-cell pertussis DTP vaccine. Anti-PT and anti-FHA responses to Tripedia were significantly higher than those to CLI's whole-cell pertussis DTP vaccine; however, higher antibody responses do not necessarily mean a greater degree of protection.
 Company Background
 Pasteur Merieux Serums & Vaccins S.A., parent organization of Connaught Laboratories, Inc., provides the largest selection of vaccines and biologicals commercially available in the world. CLI is headquartered in Swiftwater, Pa., where the company is actively involved in the field of immunological research and its applications. In addition, approximately 560 employees are engaged in manufacturing, marketing and distributing vaccines against diphtheria, tetanus, pertussis, polio, Haemophilus influenzae type b meningitis, influenza, yellow fever, rabies and other diseases. CLI is a wholly owned subsidiary of Connaught Laboratories Limited, of Toronto, Canada, a member of the Pasteur Merieux group of companies.
 -0- 8/26/92
 /CONTACT: Lauren Marcus, 212-951-5423, or Jani Denler, 212-951-5449, both of Ogilvy Adams & Rinehart, for Connaught Laboratories, Inc./ CO: Connaught Laboratories, Inc. ST: Pennsylvania IN: MTC SU:


LR-OS -- NY062 -- 3581 08/26/92 15:39 EDT
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Date:Aug 26, 1992
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