Aim: To assess suitability of a combined DTPa-HBV-IPV/Hib vaccine (Infanrix hexa) for immunization of low-birth-weight (<2.0 kg) preterm infants, with particular focus on the hepatitis B response.
Methods: Open-label study in 170 preterm infants receiving primary vaccination at 2, 4 and 6 months of age and booster vaccination at 18-24 months. Enrollment and analysis were stratified in two groups: infants with birth weight between 1.5 kg and 2.0 kg (low birth weight: LBW), infants with BW <1.5 kg (very low birth weight: VLBW).
Results: One month after the three dose primary vaccination, 93.7% and 94.9% of infants in VLBW and LBW groups, respectively, had anti-HBs antibody concentrations > or = 10 mIU/mL. High seroprotection and response rates (92.4-100%) to all vaccine antigens were observed. Those were reinforced (>98%) by booster vaccination for all antigens except for HBs in VLBW children: only 88.7% of those had anti-HBs antibody concentrations > or = 10 mIU/mL, compared with 96.5% of LBW children (difference statistically not significant). The vaccine was well tolerated in both groups of infants.
Conclusion: Preterm infants will benefit by the administration of a primary and booster vaccination with DTPa-HBV-IPV/Hib vaccine.