The new DTPw-HBV-Hib combination vaccine can be used at the who schedule with a monovalent dose of hepatitis B vaccine at birth.
An open, randomized, clinical trial was conducted in order to assess the reactogenicity and immunogenicity of DTPw-HBV and Haemophilus influenzae type b (Hib) vaccines when given either as a mixed administration or as separate concomitant injections using the WHO schedule at 6, 10 and 14 weeks of age, following a dose of HBV at birth. There were no clinically relevant differences in the immune response to any component between the mixed and separate administrations. In fact the anti-tetanus GMTs were significantly higher (p=0.002) in mixed administration (3.9 IU/ml) compared with the separate administration (1.9 IU/ml). However although all subjects achieved anti-PRP titers > or = 0.15 microg/ml, higher anti-PRP GMTs were seen in the group receiving the separate administration. Importantly, the addition of Hib did not adversely alter the reactogenicity profile of DTPw-HBV. This report which demonstrates that this novel combination can be used in WHO recommended schedule.
Bravo
L
L
University of the Philippines, Philippines General Hospital, Department of Pediatrics, Manila.
Carlos
J
J
Gatchalian
S
S
Borja-Tabora
C
C
Bibera
G
G
Willems
P
P
Safary
A
A
Bock
H L
HL
D000704:Analysis of Variance; D000914:Antibodies, Viral / Q000097:blood; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage* / Q000009:adverse effects; D004338:Drug Combinations; D006193:Haemophilus influenzae; D017325:Hepatitis B Vaccines / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007231:Infant, Newborn; D007252:Influenza Vaccines / Q000008:administration & dosage* / Q000009:adverse effects
D000914:Antibodies, Viral; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D004338:Drug Combinations; D017325:Hepatitis B Vaccines; D007252:Influenza Vaccines