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Home » Drug Information » FDA Approved Drugs » 2002
Medical Areas: Immunology | Pediatrics/Neonatology

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Daptacel

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Sanofi Pasteur
Approval Status: Approved May 2002
Treatment Area: Pediatric Immunology

General Information

Daptacel is a diptheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DTaP), approved for routine immunization in infants and children six weeks through six years of age. It is administered via intramuscular injection in four consecutive doses of the five dose immunization series. The four doses are given at approximately two months, four months, six months and six months after the third dose.

Simultaneous immunization of infants and children against diptheria, tetanus and pertussis has been a routine practice in the United States since the late 1940's. This has greatly contributed to the marked reduction in disease and deaths from these infections. Since 1997 DTaP vaccines have been recommended for all doses of the vaccination series.

Clinical Results

Approval of Daptacel is supported by data from clinical trials conducted in Sweden, Canada and the United States. In Sweden, close to 1,000 infants were randomized to receive one of four vaccines for the treatment of pertussis. These included Daptacel, another investigational acellular pertussis vaccine, whole-cell pertussis DTP vaccine or DT vaccine as placebo. During a follow-up two years after administration of the third dose, the protective efficacy of Daptacel was 85%. Identical studies performed in the United States and Canada produced similar results.

Canadian and United States clinical studies evaluated Daptacel as a preventative for diptheria and tetanus in children. After four doses of the vaccine, the portion of children with diptheria and tetanus antitoxin levels greater then or equal to a serological correlate of protection defined by the Panel on Review of Bacterial Vaccines and Toxoids, was close to 100% in both studies.

Side Effects

Adverse events associated with the use of Daptacel may include (but are not limited to) the following:


  • Drowsiness
  • Irritability
  • Anorexia
  • Injection site irritation

Mechanism of Action

Daptacel is a DTaP vaccine given in four consecutive intramuscular doses. The DTaP is about 10 times less likely to cause adverse reactions than the older DTP is. While the DTP contains the whole, inactivated pertussis bacteria, the DTaP uses only the parts of the bacteria that help the infant or child develop immunity to it and leaves behind the other parts that may have been responsible for many of the DTP's adverse effects.

Additional Information

For additional information on infant and childhood immunization, please visit the National Immunization Program.