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| |  FDA Approves Certiva Vaccine For Diphtheria, Tetanus And Pertussis BELTSVILLE, MD -- July 30, 1998 -- The United States Food and Drug Administration has approved North American Vaccine’s Certiva(TM), a combined diphtheria, tetanus and acellular pertussis (DTaP) vaccine. Certiva is indicated for active immunisation against diphtheria, tetanus and pertussis (whooping cough) in infants and children six weeks to seven years of age. Certiva will be marketed and distributed in the U.S. by the Ross Products Division of Abbott Laboratories Inc. to private physicians and managed care markets, and by North American Vaccine to government purchasers, including state governments and the Centers for Disease Control and Prevention. The acellular pertussis component of Certiva consists of a monocomponent purified pertussis toxoid that has been detoxified with hydrogen peroxide. In U.S. safety studies, local and systemic adverse events commonly associated with whole-cell DTP vaccination occurred less frequently after vaccination with Certiva. The FDA license for Certiva was supported by a number of U.S. and foreign clinical studies, including a double-blind, randomised, placebo-controlled efficacy trial conducted in Goteborg, Sweden involving 3,450 Swedish infants sponsored by the NICHD and U.S. safety studies involving 3,715 infants and children sponsored by the Company, the NICHD and the National Institute of Allergy and Infectious Diseases of the NIH. "None of the infants and children who received the vaccine in the efficacy study experienced hypotonic-hyporesponsive [collapse] episodes and the rates of local reactions, such as soreness, redness and swelling, were quite low," said Dr. John Taranger of the University of Goteborg, and co-principal investigator in the Goteborg efficacy study employing the European formulation of Certiva. "The demonstrated efficacy for CERTIVA-EU in Sweden was especially significant since the clinical study was conducted during an epidemic of pertussis," added Dr. Birger Trollfors of the University of Goteborg, and co-principal investigator in the study. The U.S. clinical studies involved 3,715 healthy infants and children in numerous study sites across the United States. In one safety and immunogenicity study, 1,303 infants were randomised to receive Certiva or a U.S.-licensed whole-cell DTP vaccine manufactured by Lederle Laboratories. The majority of these infants were immunised concurrently with an Haemophilus influenzae type b conjugate vaccine, a hepatitis B vaccine and a trivalent oral polio vaccine. The incidence of fever, redness, pain, irritability and swelling were all significantly lower after vaccination with Certiva than after immunisation with the whole-cell DTP vaccine manufactured by Lederle Laboratories. In another study, 2,283 infants received Certiva at two, four and six months of age along with other routine pediatric vaccines including vaccines against polio, Haemophilus influenzae type b and hepatitis B. Certiva was well tolerated and there were no serious adverse events judged by the clinical investigators to be vaccine related. The most common adverse events reported during the study were irritability, and redness and pain at the injection site. Certiva has also been given as the fourth and fifth doses in clinical studies and was well tolerated and immunogenic. Related Links: Certiva, Abbott
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