The clinical and immunologic response of Chilean infants to Haemophilus influenzae type b polysaccharide-tetanus protein conjugate vaccine coadministered in the same syringe with diphtheria-tetanus toxoids-pertussis vaccine at two, four and six months of age.
The safety and immunogenicity of a vaccine against Haemophilus influenzae type b consisting of purified polyribosylribitolphosphate conjugated to tetanus toxoid (PRP-T) was evaluated in 278 Chilean infants who were randomly assigned to one of three treatment groups: Group A, PRP-T mixed with diphtheria-tetanus toxoids-pertussis (DTP) vaccine in a single syringe and given as a single inoculation in one arm and placebo in the other arm; Group B, PRP-T given in one arm and DTP in the other arm; Group C, DTP given in one arm and placebo in the other. Infants were immunized at 2, 4 and 6 months of age and examined daily for 4 days after each immunization; serum PRP antibodies were measured at baseline and 2 months after each dose. The only adverse systemic reaction attributable to PRP-T beyond that caused by DTP alone was a 7 to 20% increase in febrile responses in the first 24 hours after the first and second doses of vaccine; the fevers were largely low grade and not accompanied by increased irritability, diminished activity or loss of appetite, compared with the group who received DTP without PRP-T. After the first dose 72% of infants who received PRP-T combined with DTP and 67% who received it in a separate arm attained antibody concentrations greater than or equal to 0.15 micrograms/ml. After two doses of PRP-T, 93 and 95%, respectively, had concentrations greater than or equal to 0.15 microgram/ml and after three doses 100% of infants who received PRP-T had such titers.(ABSTRACT TRUNCATED AT 250 WORDS)
Ferreccio
C
C
Center for Vaccine Development, University of Maryland School of Medicine, Baltimore 21201.
Clemens
J
J
Avendano
A
A
Horwitz
I
I
Flores
C
C
Avila
L
L
Cayazzo
M
M
Fritzell
B
B
Cadoz
M
M
Levine
M
M
D000907:Antibodies, Bacterial / Q000097:blood*; D001428:Bacterial Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D002677:Chile; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D005260:Female; D018073:Haemophilus Vaccines; D006193:Haemophilus influenzae / Q000276:immunology*; D006801:Humans; D007115:Immunization Schedule; D007223:Infant; D008297:Male; D011134:Polysaccharides / Q000276:immunology*; D013745:Tetanus Toxoid / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D014611:Vaccination
D000907:Antibodies, Bacterial; D001428:Bacterial Vaccines; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; C055753:Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate; D011134:Polysaccharides; D013745:Tetanus Toxoid; C008984:polyribitol phosphate