Safety and immunogenicity of a combination diphtheria-tetanus toxoids-acellular pertussis-hepatitis B vaccine administered at two, four and six months of age compared with monovalent hepatitis B vaccine administered at birth, one month and six months of age

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Abstract
To evaluate the safety and immunogenicity of diphtheria-tetanus toxoids-acellular pertussis (DTPa)-hepatitis B (HepB) combination vaccine given at 2, 4 and 6 months of age compared with monovalent HepB vaccine given at birth, 1 month and 6 months of age and DTPa vaccine given at 2, 4 and 6 months of age. Healthy infants were randomized to receive a combination DTPa-HepB vaccine (diphtheria and tetanus toxoids, acellular pertussis antigens and hepatitis B surface antigen), concomitantly with Haemophilus influenzae type b and oral poliovirus vaccines at 2, 4 and 6 months of age (Group 1) or HepB vaccine given at birth, 1 month and 6 months of age and DTPa, H. influenzae type b and oral poliovirus vaccines given at 2, 4 and 6 months of age (Group 2). Antibody responses were evaluated at birth, 2 months and 7 months of age. Safety was evaluated after each immunization using diary cards and parental interviews. One month after the third dose (7 months of age), the geometric mean concentration of antibody to hepatitis B surface antigen was ∼3.5-fold higher in Group 2 than in Group 1 infants (3643 and 1052 mIU/ml, respectively;P < 0.001). Nevertheless the rates of seroprotection to HepB (antibody to hepatitis B surface antigen ≥10 mIU/ml) in Groups 1 and 2 were similar, 99 and 100%, respectively. Also the postvaccination geometric mean concentrations and rates of seroprotection or vaccine response to all of the other vaccine antigens evaluated were similar or greater in Group 1 than in Group 2. The rates of adverse events were similar between the two groups, with fussiness and soreness at any injection site reported most frequently. The DTPa-HepB combination vaccine was safe and immunogenic when given to infants at 2, 4 and 6 months of age. Equivalent rates of seroprotection to hepatitis B were achieved despite a reduction of the interval between the second and third doses from 5 months in Group 2 to 2 months in Group 1. Hepatitis B-containing combination vaccines should reduce the number of vaccine injections required in childhood and maintain excellent seroprotection against multiple pathogens.