New Diphtheria, Tetanus and Acellular Pertussis Vaccine Effective for Primary Vaccination for Children, Study Shows

ORLANDO, Fla., Oct. 5, 1994 -- A study reported today shows that a new vaccine combining acellular pertussis antigens, diphtheria and tetanus toxoids provides protection for use in primary vaccination for children. The results of the study were presented at the 34th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC).

The study was a prospective, blinded household contact clinical trial in six areas of Germany, to determine the protective efficacy of a three-dose primary vaccination course of the new developmental SmithKline Beecham combined diphtheria, tetanus and acellular pertussis vaccine (DTPa) in young children. The vaccination schedule was a dose at 3, 4 and 5 months of age.

"This study showed the protective efficacy of the new vaccine was 89.9% against 'typical' pertussis as defined by the World Health Organization (WHO)," said Professor Doctor Heinz J. Schmitt, Children's Hospital, University of Mainz, Germany, and lead investigator for the study. "Pertussis (whooping cough) is a highly communicable bacterial disease that is very serious in children under age 2. Worldwide, pertussis is endemic with an estimated 50 million new cases every year leading to 500,000 deaths."

"In many countries, DTP vaccination has been recommended for all children prior to entering school. In the United States, it is mandatory," said Dr. Ralf Clemens, vice president, Clinical R&D, SmithKline Beecham Biologicals. "However, primary vaccination is currently carried out with whole-cell pertussis vaccines which have been associated with a number of side effects. Controversy still exists about the association of the whole-cell vaccines with rare,

severe side effects such as encephalopathy. As a result, many parents either are not getting their children vaccinated or are delaying until just prior to entering school."

The new acellular pertussis vaccine may offer advantages over classical whole-cell vaccines including improved tolerability, with less local and systemic side effects, which may improve acceptance by parents and physicians. As with most vaccines, the most commonly reported side effect with the new vaccine was pain and swelling at the injection site, which generally resolved within 24-48 hours without treatment.

"Over thirty thousand children have been vaccinated with the new vaccine in worldwide clinical trials," said Dr. Clemens. "This past May, the vaccine was launched in Germany under the tradename, Infanrix, for booster use after a primary course of a whole-cell pertussis vaccine. We expect to file for approval for primary vaccination in the coming months."

SmithKline Beecham is currently developing worldwide a number of combined vaccines containing the new acellular DTPa vaccine plus additional components of hepatitis B, polio and Haemophilius influenzae type b. Studies are currently in Phase III.


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Posted: July 2004

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