[Quadrivalent vaccine against diphtheria, tetanus, B. pertussis and hepatitis B: experience in Spain].
OBJECTIVE
The objective of this study was to perform a pooled analysis of the immunogenicity and reactivity results obtained in 2 trials carried out in Spain with a combined DTP-HB vaccine.


METHODS
Vaccine was administered according to one of two existing vaccination schedules: 2-4-6 and 3-5-7 months of age. Blood samples for antibody determination were obtained 3-6 weeks after the third dose. Anti-diphtheria, anti-tetanus and anti- B. pertussis antibodies were measured by ELISA and anti-HB by radioimmunoassay. Local and general signs and symptoms were recorded by the parents on diary cards for a 4-day follow-up period after each vaccination.


RESULTS
A total of 231 infants received three doses of DTP-HB vaccine. All of these doses were accompanied by the corresponding diary card (693 data points for the evaluation of reactogenicity). Two-hundred and nineteen subjects ere included in the analysis of immunogenicity. After the full vaccination course, all subjects had sero-protective titers against diphtheria, tetanus and hepatitis B and were sero-positive of B. pertussis. Geometric mean titers of anti-HB antibodies was 1986 mIU/ml. Pain at the injection site (64%) and unusual crying (71.5%) were the most frequently reported local and general symptoms, respectively. Fever (rectal temperature > or = 38 degrees C) was reported after 46% of the doses, but was considered as severe (> 39.5 degrees C) only in 5 cases.


CONCLUSIONS
These results show that this combined DTP-HB vaccine induced a strong immune response to all vaccine components. The safety profile of this DTP-HB is similar to that of classical DTP vaccines.
González López
A
A
Departmento Médico, SmithKline Beecham Pharmaceuticals, Madrid, España.
Arístegui Fernández
J
J
Díez-Delgado
J
J
Dal-Ré Saavedra
R
R
D000914:Antibodies, Viral / Q000276:immunology; D004165:Diphtheria / Q000517:prevention & control*; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000276:immunology*; D004311:Double-Blind Method; D004797:Enzyme-Linked Immunosorbent Assay; D006509:Hepatitis B / Q000517:prevention & control*; D017325:Hepatitis B Vaccines / Q000276:immunology*; D006801:Humans; D007223:Infant; D013030:Spain; D013742:Tetanus / Q000517:prevention & control*; D017778:Vaccines, Combined / Q000276:immunology; D014917:Whooping Cough / Q000517:prevention & control*
D000914:Antibodies, Viral; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D017325:Hepatitis B Vaccines; D017778:Vaccines, Combined
Vacuna tetravalente frente a difteria, tétanos, B. pertussis y hepatitis B: experiencia en España.