Immunogenicity and reactogenicity of a combined adsorbed tetanus toxoid, low dose diphtheria toxoid, five component acellular pertussis and inactivated polio vaccine in six-year-old children.
BACKGROUND
The objective of this study was to assess the immunogenicity and reactogenicity of the combined adsorbed tetanus toxoid, low dose diphtheria toxoid, 5-component acellular pertussis and inactivated polio vaccine (TdcP-IPV) as compared with a pediatric dose diphtheria formulation, combined with adsorbed tetanus toxoid and 3-component acellular pertussis (DTacP), in 6-year-old children who were immunized with 4 doses of diphtheria-tetanus-whole cell cellular pertussis (DTwcP) plus oral polio vaccine (OPV) before 2 years of age, according to the local Spanish vaccination calendar.


METHODS
One hundred ninety-four healthy 6-year-old children were randomized to receive 1 dose of TdcP-IPV or 1 dose of DTacP and OPV.


RESULTS
One month postvaccination, antidiphtheria and antitetanus titers were > or =0.1 IU/mL in 100% of patients in both study groups. TdcP-IPV reached 100% seroprotection rates against polio types 1, 2 and 3. In OPV recipients, these rates were 100, 100 and 96.8%, respectively. Seropositivity rates for pertussis toxin, filamentous hemagglutinin, pertactin and fimbrial components of the TdcP-IPV vaccine were 97.9, 89.6, 90.6 and 100%. The incidence of local and systemic reactions was 50.5 and 39.2% in the TdcP-IPV group and 59.4 and 38.5% in the DTacP plus OPV group, and no serious adverse events were reported.


CONCLUSIONS
TdcP-IPV vaccine was shown to be immunogenic and safe when given as a booster in children 6 years of age who were primed with 4 doses of DTwcP and OPV.
Diez-Domingo
Javier
J
Pediatría, Centros de Salud, VIVA, Valencia, Spain.
Delgado
Javier Díez
JD
Ballester
Alfredo
A
Baldó
José María
JM
Planelles
María Victoria
MV
Garcés
María
M
Graullera
Marta
M
Ubeda
Maria Isabel
MI
Sánchez
Francisco
F
Sánchez
Maria Mar
MM
Azor
Ernestina
E
Cabrera
Antonio
A
López
Francisca
F
Alvarez
Mariano
M
San-Martín
María
M
González
Antonio
A
Boisnard
Florence
F
Thomas
Stéphane
S
D002648:Child; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage / Q000276:immunology*; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines / Q000008:administration & dosage / Q000276:immunology*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007109:Immunity / Q000502:physiology*; D007115:Immunization Schedule; D007156:Immunologic Memory; D008297:Male; D011055:Poliovirus Vaccine, Oral / Q000008:administration & dosage / Q000276:immunology*; D018570:Risk Assessment; D012680:Sensitivity and Specificity; D016037:Single-Blind Method; D017778:Vaccines, Combined / Q000008:administration & dosage / Q000276:immunology
D015721:Diphtheria-Tetanus-Pertussis Vaccine; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D011055:Poliovirus Vaccine, Oral; D017778:Vaccines, Combined