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