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Home Industry News Sanofi Pasteur announces fifth dose Daptacel success

Sanofi Pasteur announces fifth dose Daptacel success

17th March 2008

Sanofi Pasteur, the vaccines segment of Sanofi-Aventis, has reported the successful use of Daptacel (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) as a fifth consecutive dose in a number of clinical trials.

At tests conducted at 22 different trial sites, 98 per cent of subjects completed the 180-day safety follow-up following the administration of the fifth dose.

In total, ten children did not complete this follow-up, with three lost to follow-up, six discontinued due to noncompliance and one voluntary withdrawal, with no children withdrawing as a result of contraindication or adverse events.

Consequently, the US Food and Drug Administration has licensed the compound to be administered as a fifth consecutive vaccine dose for children aged four to six for the prevention of diphtheria, tetanus and pertussis.

“Following administration of Daptacel vaccine as the fifth dose, more than 93 percent of subjects experienced a booster response to each of the pertussis components,” the company said.

“Additionally, all participants achieved antibody responses equal or more than 0.1 IU/mL for both the tetanus and diphtheria antigens.”

This level indicates that protective levels of antibodies had been achieved, the company added.

In May 2007, Sanofi Pasteur announced the launch of a website offering travellers information regarding infectious diseases and available immunisation programmes.

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