The Immunogenicity and Reactogenicity of a New DTPw-HBV Vaccine as a Primary and Booster Vaccination Dourse in Healthy Infants

Abstract

The immunogenicity and reactogenicity of primary vaccination at 3, 4 and 5 months and boosting at 12-18 months with a new DTPw-HBV vaccine was compared with either licensed DTPw and HBV vaccines given separately or a licensed DTPw-HBV combination (Tritanrix™ HepB) in this randomised, partially double-blind primary vaccination and single-blind booster vaccination study in healthy infants (n=239; Trial DTPw-HBV-001/004). One month after primary vaccination with the new DTPw-HBV vaccine, seroprotection against diphtheria, tetanus, hepatitis B and vaccine response to B. pertussis was seen in 100%, 98.7%, 94.9% and 98.7% of subjects, respectively, compared to 100%, ≥98.5%, 89.2% and 92.2% of subjects in the comparator groups, respectively. One month after the booster dose, a marked response to all vaccine antigens was observed, resulting in seroprotection against diphtheria, tetanus, hepatitis B in all DTPw-HBV recipients and response to B. pertussis in over 98.6%. After primary vaccination, there was evidence that fever ≥ 38.0°C (rectal route) occurred more frequently after the new vaccine (following 41.6% of doses, compared with 32.2% and 29.3% in the comparator groups, p