A single dose of Quadracel vaccine is approved for use in children four through six years of age as a fifth dose in the diphtheria, tetanus, pertussis vaccination (DTaP) series, and as a fourth or fifth dose in the inactivated poliovirus vaccination (IPV) series, in children who have received four doses of Pentacel and/or DAPTACEL
(Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed), stated the company.
In addition, new data suggest the potential for immunologic interference in the meningococcal human complement serum bactericidal assay (hSBA) responses when MenACWY-D is administered 30 days after Daptacel
(diphtheria and tetanus toxoids and acellular pertussis vaccine [DTaP], Sanofi Pasteur) (16).
Formulation Adjuvant Adverse reactions Tripedia Aluminum potassium sulfate 11,178 Daptacel
Aluminum phosphate 8,786 Infanrix Aluminum hydroxide 13,238 TABLE 7: Adverse reactions reported in VAERS for sulfate versus hydroxide in age-matched samples, and the likelihood that the contrasts observed in these distributions could have occurred by chance (p < 0.05).
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
Quadracel is approved for administration as a fifth dose in the DTaP series and as a fourth or fifth dose in the IPV series in children aged 4 through 6 years who have received 4 doses of DTaP-IPV-Hib (Pentacel, Sanofi Pasteur) and/or DTaP (Daptacel
, Sanofi Pasteur) vaccine (2,3).
The company has received approval based on data from a pivotal multicentre, randomised, controlled, Phase III trial designed to compare the safety and immunogenicity of Quadracel vaccine with DAPTACEL
and IPOL vaccines in these children who were previously vaccinated with DAPTACEL
and/or Pentacel vaccines.
ACIP didn't take an official vote on their inclusion in the childhood immunization schedule because neither vaccine contains novel antigens: Pentacel contains the same five acellular pertussis antigens that are included in Sanofi Pasteur's DTaP vaccine for children (Daptacel
) as well as the company's Tdap vaccine for adults and adolescents (Adacel).
Adacel[TM] contains reduced amounts of the diphtheria and pertussis components of Daptacel
. * The whole-cell vaccines differed; some are not available in the United States.
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.S.
Additionally, the 2D barcode will include Daptacel
(Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed); Tenivac (Tetanus and Diphtheria Toxoids Adsorbed); IPOL (Poliovirus Vaccine Inactivated) and Pentacel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)) vaccine.