Immunogenicity and safety of a DTaP-IPV//PRP approximately T combination vaccine given with hepatitis B vaccine: a randomized open-label trial.
OBJECTIVE
To determine seroprotection and vaccine response rates produced by a diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae type-b conjugate (DTaP-IPV//PRP approximately T) vaccine containing a polyribosyl-ribitol-phosphate (PRP)-tetanus toxoid conjugate (Pentaxim) and given with a hepatitis B vaccine.


METHODS
In this multicentre open-label trial, 424 infants who received DTaP-IPV//PRP approximately T at 6, 10 and 14 weeks of age were also randomized to receive hepatitis B vaccine at either 6, 10 and 14 weeks or 0, 6 and 14 weeks of age. Antibody levels were determined at 6 and 18 weeks of age, and reactogenicity was monitored using parental reports.


RESULTS
Immunogenicity was high for all vaccine antigens and was similar to that in a historical control study. After primary vaccination, 98.7% of all infants had an anti-PRP antibody titre > 0.15 microg/ml. Seroprotection against poliovirus type-1, -2 and -3 and tetanus was obtained in all infants, and against diphtheria, in 97.1%. Pertussis seroconversion, defined as a > fourfold increase in antibody titre, occurred in 95.3% for anti-pertussis toxoid antibody and in 89.0% for anti-filamentous haemagglutinin antibody. The hepatitis B seroprotection rate was 99.5% with administration at 0, 6 and 14 weeks, and 97.8%, at 6, 10 and 14 weeks. However, the antibody titre was higher with the 0, 6 and 14-week schedule (601 mIU/ml versus 207 mIU/ml). The reactogenicity of both vaccines was low.


CONCLUSIONS
The DTaP-IPV//PRP approximately T vaccine was highly immunogenic. The anti-hepatitis B antibody response was seroprotective with both schedules, though the antibody titre was higher with the 0, 6 and 14-week schedule.
Research Institute for Tropical Medicine, Manila, the Philippines.
Maria Rosario
MR
Capeding
Josefina
J
Cadorna-Carlos
May
M
Book-Montellano
Esteban
E
Ortiz
D000917:Antibody Formation / Q000187:drug effects; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D005260:Female; D018073:Haemophilus Vaccines; D006509:Hepatitis B / Q000188:drug therapy / Q000235:genetics / Q000276:immunology / Q000821:virology; D006510:Hepatitis B Antibodies / Q000187:drug effects; D017325:Hepatitis B Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D006801:Humans; D007223:Infant; D008297:Male; D010679:Philippines; D011054:Poliovirus Vaccine, Inactivated; D011134:Polysaccharides / Q000627:therapeutic use*; D017778:Vaccines, Combined / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology / Q000627:therapeutic use
C451839:DTPa-HBV-IPV combined vaccine; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines; D011054:Poliovirus Vaccine, Inactivated; D011134:Polysaccharides; D017778:Vaccines, Combined; C008984:polyribitol phosphate