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[The safety and immunogenicity of an heptavalent pneumococcal polysaccharide conjugate vaccine (Prevenar) administered in association with a whole-cell pertussis-based pediatric combination vaccine (DTP-IPV/PRP-T) to French infants with a two-, three-, and four-month schedule].

AbstractUNLABELLED:
Invasive pneumococcal disease is presently a leading cause of mortality due to bacterial infectious diseases in French children less than 2 years of age, and only the pneumococcal conjugate vaccines induce a protective immune response for those within this vulnerable age group.
MATERIAL AND METHODS:
The safety and immunogenicity of a heptavalent pneumococcal polysaccharide conjugate vaccine (PREVENAR was tested in French infants immunized with the 2, 3 and 4 month French schedule as part of an open, randomized, comparative clinical study, in association with a whole-cell pertussis-based pediatric combination vaccine.
RESULTS:
In the PREVENAR plus DTP-IPV/Hib association group, 90.6-100% of children achieved a post-dose three threshold IgG concentration of >0.15 microg/ml against each of the seven pneumococcal serotypes. Regarding immunogenicity, no interference with the antibody response to the various antigenic components of the DTP-IPV/Hib vaccine was observed. Local reactions were significantly less frequent at the PREVENAR injection site than at the DTP-IPV/Hib injection site; there was no increase in systemic adverse events in the vaccine association group compared to the DTP-IPV/Hib alone group, further exception of fever >38 degrees C which was more frequently reported in the PREVENAR + PENTACOQ group following the second dose of vaccines (56% vs. 35%); no serious adverse event could be considered to be related to the PREVENAR immunization in this study.
CONCLUSION:
The heptavalent pneumococcal conjugate vaccine is immunogenic when administered at 2, 3 and 4 months. PREVENAR can be administered simultaneously with the DTP-IPV/Hib combination vaccine.
AuthorsP Reinert, M Guy, B Girier, B Szelechowski, B Baudoin, P Deberdt, A Wollner, G Kemeny, M Amzallag, C Moat, C Szelechowski, H Villain-Lemoine, C-A Bouhanna, F Laudat
JournalArchives de pediatrie : organe officiel de la Societe francaise de pediatrie (Arch Pediatr) Vol. 10 Issue 12 Pg. 1048-55 (Dec 2003) ISSN: 0929-693X [Print] France
Vernacular TitleTolérance et immunogénicité d'un vaccin pneumococcique osidique conjugué heptavalent (Prevenar) administré en association avec une combinaison vaccinale pédiatrique (DTCoq-Polio/Hib) à des nourrissons selon le schéma vaccinal français à l'âge de deux, trois et quatre mois.
PMID14643532 (Publication Type: Clinical Trial, English Abstract, Journal Article, Randomized Controlled Trial)
Chemical References
  • Diphtheria-Tetanus-Pertussis Vaccine
  • Haemophilus Vaccines
  • Heptavalent Pneumococcal Conjugate Vaccine
  • Immunoglobulin G
  • Meningococcal Vaccines
  • Pneumococcal Vaccines
  • Vaccines, Conjugate
  • diphtheria-tetanus-pertussis-haemophilus b conjugate vaccine
Topics
  • Diphtheria-Tetanus-Pertussis Vaccine (administration & dosage)
  • Female
  • Haemophilus Vaccines (administration & dosage)
  • Heptavalent Pneumococcal Conjugate Vaccine
  • Humans
  • Immunization Schedule
  • Immunoglobulin G (analysis)
  • Infant
  • Male
  • Meningococcal Vaccines (administration & dosage, adverse effects, immunology)
  • Pneumococcal Infections (prevention & control)
  • Pneumococcal Vaccines (administration & dosage, adverse effects, immunology)
  • Vaccines, Conjugate

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