DTaP5-HB-IPV-Hib demonstrated comparable immunogenicity and safety to other approved vaccinations in randomized active-comparator controlled trials. This study looked at the durability of anti-hepatitis B surface antigen (HBs) and anti-pertussis antibodies in children aged 4-5 years old. This was a follow-up to two European trials in which infants/toddlers were given either DTaP5-HB-IPV-Hib or DTaP3-HB-IPV/Hib on a 2 + 1 or 3 + 1 schedule. Anti-HBs 10 mIU/mL, anti-pertussis toxin (PT), anti-filamentous hemagglutinin (FHA), anti-pertactin (PRN), and anti-fimbriae types 2 & 3 (FIM) levels greater than or equal to the lower limit of quantification were the primary objectives (LLOQ). Anti-HBs 10 mIU/mL were found in 65.8%-70.2% of the DTaP5-HB-IPV-Hib and 82.0%-83.7% of the DTaP3-HB-IPV/Hib groups, respectively, 3 to 4 years later.
In the DTaP5-HB-IPV-Hib and DTaP3-HB-IPV/Hib groups, the percentages of children with pertussis antibodies above LLOQ after 2 + 1 dosing were 58.4 percent and 41.5 percent (anti-PT), 80.9 percent and 88.3 percent (anti-FHA), 66.1 percent and 72.6 percent (anti-PRN), and 94.4 percent and 3.3 percent (anti-FIM). This study found that hepatitis B and pertussis antibodies decreased 3 to 4 years after completing a 3 + 1 or 2 + 1 hexavalent immunization regimen. Despite this, most research participants had anti-HBs levels of 10 IU/mL and measurable antibodies against acellular pertussis antigens.