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Research Paper
A New DTPw-HBV/Hib Vaccine is Immunogenic and Safe when Administered According to the EPI (Expanded Programme for Immunization) Schedule and Following Hepatitis B Vaccination at Birth
Salvacion Gatchalian, Marietta Reyes, Nancy Bernal, Inge Lefevre, Marie-Pierre David, Htay Htay Han, Hans L Bock, Joanne Wolter and Lode Schuerman
volume 1 | issue 5
september/october 2005Pages: 198 - 203
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New combination vaccines and reliable sources of vaccine components are essential to ensure the success of mass immunisation programmes in the 21st century. We evaluated a new combined diphtheria-tetanus-whole-cell-pertussis-hepatitis B vaccine, extemporaneously mixed with a Haemophilus influenzae type b conjugate vaccine (DTPw-HBV/Hib) containing 2.5?g PRP in 913 Philippino infants, administered according to the EPI schedule at 6, 10 and 14 weeks of age after a birth dose of hepatitis B vaccine (HBV; trial DTPw-HBV/Hib-001). One month after the third dose of DTPw-HBV/Hib (N=182), 99.4% and 94.2% of subjects had anti-PRP antibody levels ?0.15µg/mL and ?1.0µg/mL, respectively. In addition, 95.9%, 100.0% and 87.6% of subjects had seroprotective antibody concentrations against diphtheria, tetanus and hepatitis B, respectively. The seroprotection rate to hepatitis B increased significantly to 94.3% in subjects who received a dose of HBV at birth. The pertussis vaccine response rate was ?95%. Seroprotection/vaccine response rates to all antigens after DTPw-HBV/Hib were at least as good as those observed after vaccination with GSK Biologicals’ licensed TritanrixTMHepB/HiberixTM (containing 10?g PRP) which was used as comparator. Although redness >20mm in diameter and fever ?37.5°C (axillary route) occurred more often after the new DTPw-HBV/Hib vaccine (p<0.05), other Grade 3 adverse events occurred similarly between the groups. The new DTPw-HBV/Hib vaccine was as immunogenic and well tolerated as the licensed control vaccine when administered according to the immunologically challenging EPI schedule. A birth dose of HBV is important to maximise protection against hepatitis B in endemic regions where the EPI schedule is in place.
We now provide open access to journal articles published online for one year or more. This article may be downloaded at the following link:
Download PDF If the document does not open, please right-click on the link (control-click on a Macintosh) and select the option to save the file to disk.