This FDA approval is based on data from a pivotal multicenter, randomized, controlled, Phase III study designed to compare the safety and immunogenicity of Quadracel vaccine (DTaP-IPV) with DAPTACEL
(DTaP) and IPOL (IPV) vaccines in children 4 through 6 years of age who were previously vaccinated with DAPTACEL
and/or Pentacel (DTaP-IPV/Hib) vaccines.
The study was funded by Sanofi-Pasteur, maker of Daptacel
One of the reasons for the confusion is that the labeling and packaging are very similar for Adacel (Tdap) and Daptacel
It has already started to manufacture the DTaP vaccine Daptacel
, and will begin producing Adacel next, she said.
In fact, Aventis Pasteur has already received approval to produce a new DTaP vaccine, Daptacel
, to complement our U.
The DtaP vaccine Daptacel
, indicated for infants and children, contains somewhat different levels of the three components.
The safety of Pentacel vaccine was compared both to separately administered DAPTACEL
, IPOL and ActHIB vaccines (study P3T06) and to other single-entity vaccine formulations (study 494-01).
The other candidate Tdap vaccine, Adacel, is nearly identical to Sanofi Pasteur's currently licensed DTaP vaccine, Daptacel
, except that it contains lower levels of diphtheria toxoid and one of five pertussis antigens.
The immunogenicity of Pentacel(R) vaccine was compared to separately administered DAPTACEL
, IPOL(R)(c) and ActHIB(R)(d) vaccines (studies P3T06 and M5A10), as well as to other single-entity vaccine formulations (study 494-01).
vaccine is licensed for the entire immunization series to protect against diphtheria, tetanus, and pertussis -
In clinical studies, DAPTACEL
vaccine has been shown to provide 85 percent efficacy against severe pertussis (cough lasting 21 days or longer) and 78 percent efficacy against all severities of pertussis.
Among the other key drivers was the ongoing strong sales of the trivalent pediatric vaccine Daptacel
in the U.