Document Detail

Clinical acceptability and immunogenicity of a pentavalent parenteral combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b conjugate antigens in two-, four- and six-month-old Chilean infants.
MedLine Citation:
PMID:  9576383     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: In recent years additional parenteral vaccines have been recommended for routine immunization of infants in the US and elsewhere. The ability to administer multiple vaccines as a single injection without unacceptably increasing reactogenicity or decreasing immunogenicity of any component would offer many practical advantages. METHODS: A randomized, open, controlled trial was conducted to assess the tolerance profile and immunogenicity, as well as to identify potential antigenic interferences, resulting from administration of a parenteral combination vaccine for infants. The vaccine contains diphtheria and tetanus toxoids, acellular pertussis antigens (DTaP), enhanced inactivated poliovirus (eIPV) and Haemophilus influenzae type b-tetanus toxoid conjugate (PRP-T). Infants (n=711) were randomly assigned to receive 1 of 5 regimens as the primary series at 2, 4 and 6 months of age, by group: (1) DTaP plus oral polio vaccine (OPV); (2) DTaP plus eIPV (separate injections); (3) DTaP-eIPV combined as a single injection; (4) DTaP-eIPV combined, plus a separate injection of PRP-T; or (5) DTaP-eIPV combined and reconstituting PRP-T, as a single injection. At 3, 5 and 7 months Groups 1, 2 and 3 received PRP-T. At 12 months all infants received a booster dose of DTaP reconstituting PRP-T as a single injection, plus a separate injection of measles, mumps and rubella vaccine. Groups 2, 3, 4 and 5 received OPV at 7 months, and all infants received OPV at 13 months. Serum immune responses were measured to the primary series at 2 and 7 months and to the booster dose at 12 and 13 months. RESULTS: Reaction rates were similar among groups. In the primary series combining eIPV with DTaP decreased geometric mean titers (GMTs) to diphtheria, tetanus and pertussis. In addition concomitant PRP-T (either simultaneous or combined) with DTaP-eIPV lowered anti-PRP and further decreased tetanus GMTs. Nonetheless in 100% of infants protective titers were achieved against diphtheria and tetanus (>0.01 IU/ml each) and against the poliovirus types 1, 2 and 3 after eIPV (Groups 2 to 5); 99% of infants (Groups 4 and 5) had protective titers against PRP (> or = 0.15 microg/ml). After boosting with DTaP/PRP-T decreased GMTs to diphtheria and PRP antigens were observed in the groups that received DTaP and eIPV combined. Nonetheless protective titers to diphtheria, tetanus and PRP occurred consistently. In contrast concomitant PRP-T with DTaP-eIPV enhanced the pertussis GMTs. CONCLUSIONS: We conclude that combined DTaP, eIPV and PRP-T in a single injection is well-tolerated and elicits an acceptable immune response to each component.
R Lagos; K Kotloff; A Hoffenbach; O San Martin; P Abrego; A M Ureta; E Pines; C Blondeau; F Bailleux; M M Levine
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Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The Pediatric infectious disease journal     Volume:  17     ISSN:  0891-3668     ISO Abbreviation:  Pediatr. Infect. Dis. J.     Publication Date:  1998 Apr 
Date Detail:
Created Date:  1998-06-25     Completed Date:  1998-06-25     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  8701858     Medline TA:  Pediatr Infect Dis J     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  294-304     Citation Subset:  IM    
Centro para Vacunas en Desarrollo, Chile, Servicio de Salud Metropolitano Norte, Santiago.
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MeSH Terms
Adhesins, Bacterial / immunology
Antibodies, Bacterial / blood
Antibodies, Viral / blood
Diphtheria Toxin / immunology
Diphtheria-Tetanus-Pertussis Vaccine / administration & dosage*,  adverse effects,  immunology
Haemophilus Vaccines / administration & dosage*,  adverse effects,  immunology
Haemophilus influenzae / immunology
Hemagglutinins / immunology
Immunization Schedule
Immunization, Secondary
Poliovirus / immunology
Poliovirus Vaccine, Inactivated / administration & dosage*,  adverse effects,  immunology
Poliovirus Vaccine, Oral / administration & dosage,  adverse effects,  immunology
Tetanus Toxin / immunology
Tetanus Toxoid / administration & dosage*,  adverse effects,  immunology
Toxoids / immunology
Vaccines, Combined / administration & dosage,  adverse effects,  immunology
Vaccines, Conjugate / administration & dosage,  adverse effects,  immunology
Virulence Factors, Bordetella*
Reg. No./Substance:
0/Adhesins, Bacterial; 0/Antibodies, Bacterial; 0/Antibodies, Viral; 0/Diphtheria Toxin; 0/Diphtheria-Tetanus-Pertussis Vaccine; 0/Haemophilus Vaccines; 0/Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate; 0/Hemagglutinins; 0/Poliovirus Vaccine, Inactivated; 0/Poliovirus Vaccine, Oral; 0/Tetanus Toxin; 0/Tetanus Toxoid; 0/Toxoids; 0/Vaccines, Combined; 0/Vaccines, Conjugate; 0/Virulence Factors, Bordetella; 0/filamentous hemagglutinin adhesin, Bordetella pertussis; 0/pertussis toxoid

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