Evaluation of the immunogenicity and reactogenicity of a DTPa-HBV-IPV combination vaccine co-administered with a hib conjugate vaccine either as a single injection of a hexavalent combination or as two separate injections at 3, 5 and 11 months of age

Scandinavian Journal of Infectious Diseases

Volumn 36, Issue 8, 2004, Pages 585-592

  Gabutti, Giovanni ^a   Zepp, Fred ^e   Schuerman, Lode ^f   Dentico, Pietro ^b   Bamfi, Francesco ^d   Soncini, Renato ^d   Habermehl, Peter ^e   Knuf, Markus ^e   Crovari, Pietro ^c   Penna, Cleonice ^c   Ciucci, Antonella ^c   Bona, Gianni ^g   Ambrosioni, Gabriele ^h   De Mattia, Domenico ^b   Giammanco, Giuseppe ⁱ   Principi, Nicola ^j   Barbuti, Salvatore ^b   Ruggenini, Angela Moiraghi ^k   Napoletano, Giuseppina ^l   Pellegrino, Angela ^m   Montú, Domenico ⁿ   more..

^a UNIVERSITY OF SALENTO   (Italy)

^b UNIVERSITY OF BARI   (Italy)

^c UNIVERSITY OF GENOA   (Italy)

^d GSK   (Italy)

^e UNIVERSITY MEDICAL CENTER MAINZ   (Germany)

^f GLAXOSMITHKLINE BIOLOGICALS   (Belgium)

^g Clinical Pediatrics   (Italy)

^h MAGGIORE HOSPITAL   (Italy)

ⁱ UNIVERSITY OF CATANIA   (Italy)

^j UNIVERSITY OF MILAN   (Italy)

^k UNIVERSITY OF TURIN   (Italy)

^l Department of Public Health/Hygiene   (Italy)

^m LHU 15   (Italy)

ⁿ Department of Public Health/Hygiene   (Italy)

more..

Author keywords

[No Author keywords available]

Indexed keywords

DIPHTHERIA ANTIBODY; DIPHTHERIA PERTUSSIS TETANUS HAEMOPHILUS INFLUENZAE TYPE B VACCINE; HEPATITIS B SURFACE ANTIBODY; HEPATITIS B VACCINE; NEUTRALIZING ANTIBODY; POLIOMYELITIS VACCINE; TETANUS ANTIBODY;

ANOREXIA; ANTIBODY BLOOD LEVEL; ANTIBODY DETECTION; ANTIBODY RESPONSE; ARTICLE; CHRONOTHERAPY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIPHTHERIA; DROWSINESS; DRUG DOSE REGIMEN; DRUG FEVER; DRUG TOLERABILITY; ENZYME LINKED IMMUNOSORBENT ASSAY; EVALUATION; FEASIBILITY STUDY; FEMALE; GRAM NEGATIVE INFECTION; HAEMOPHILUS INFLUENZAE TYPE B; HEPATITIS B; HUMAN; HUMAN EXPERIMENT; IMMUNE RESPONSE; IMMUNOGENICITY; IMMUNOREACTIVITY; INCIDENCE; INFANT; INFANT DISEASE; INJECTION; MALE; NONHUMAN; NORMAL HUMAN; PERTUSSIS; PHASE 3 CLINICAL TRIAL; POLIOMYELITIS; RADIOIMMUNOASSAY; RANDOMIZED CONTROLLED TRIAL; RESTLESSNESS; STATISTICAL SIGNIFICANCE; SYMPTOMATOLOGY; TETANUS; VACCINATION;

ANTIBODIES, BACTERIAL; ANTIBODIES, VIRAL; CONFIDENCE INTERVALS; ENZYME-LINKED IMMUNOSORBENT ASSAY; FEMALE; FOLLOW-UP STUDIES; GERMANY; HAEMOPHILUS VACCINES; HUMANS; IMMUNITY, CELLULAR; IMMUNIZATION SCHEDULE; INFANT; INJECTIONS, INTRAMUSCULAR; ITALY; MALE; POLYSACCHARIDES, BACTERIAL; PROBABILITY; RISK ASSESSMENT; VACCINATION; VACCINES, COMBINED;

EID: 4544269742     PISSN: 00365548     EISSN: None     Source Type: Journal    
DOI: 10.1080/00365540410017572     Document Type: Article

References (26)

1. Bonanni P, Bergamini M. Factors influencing vaccine uptake in Italy. Vaccine 2002; 20: S8-12.
2. Ellis RE. Development of combination vaccines. Vaccine 1999; 17: 1635-2.
3. Hadler SC. Cost benefit of combining antigens. Biologicals 1994; 22: 415-8.
4. Andrè FE. Development and clinical application of new polyvalent combined paediatric vaccines. Vaccine 1999; 17: 1620-7.
5. Gylca R, Gylca V, Benes O, Melnic A, Chicu V, Weisbecker C. A new DTPa-HBV-IPV vaccine co-administered with Hib, compared to a commercially available DTPw-IPV/Hib vaccine co-administered with HBV, given at 6, 10 and 14 weeks following HBV at birth. Vaccine 2000; 19: 825-33.
6. Zepp F, Schuind A, Meyer C, Sänger R, Kaufhold A, Willems P. Safety and reactogenicity of a novel DTPa-HBV-IPV combined vaccine given with commercial Hib vaccines in comparison with separate concomitant administration of DTPa, Hib, and OPV vaccines in infants. Pediatrics 2002; 109: 1-8.
7. Yeh SH, Ward JI, Partridge S, Marcy SM, Lee H, Jing J, et al. Safety and immunogenicity of a pentavalent diphtheria, tetanus, pertussis, hepatitis B and polio combination vaccine in infants. Pediatr Infect Dis 2001; 20: 973-80.
8. Capiau C, Poolman J, Hoet B, Bogaerts H, Andre F. Development and clinical testing of multivalent vaccines based on a diphtheria-tetanus-acellular pertussis vaccine: difficulties encountered and lessons learned. Vaccine 2003; 21: 2273-87.
9. Schmitt HJ, Knuf M, Ortiz E, Sanger R, Uwamwezi MC, Kaufhold A. Primary vaccination of infants with diphtheria-tetanus-acellular pertussis-hepatitis B virus- inactivated polio virus and Haemophilus influenzae type b vaccines given as either separate or mixed injections. J Pediatr 2000; 137: 304-12.
10. Aristegui J, Dal-Ré R, Diez-Delgado JD, Marés J, Casanovas JM, Garcia-Corbeira P, et al. Comparison of the reactogenicity and immunogenicity of a combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated polio (DTPa-HBV-IPV) vaccine, mixed with the Haemophilus influenzae type b (Hib) conjugate vaccine and administered as a single injection, with the DTPa-IPV/Hib and hepatitis B vaccines administered in 2 simultaneous injections to infants at 2, 4 and 6 months of age. Vaccine 2003; 21: 359-600.
11. Schmitt HJ, Booy R, Weil-Olivier C, Van Damme P, Cohen R, Peltola H. Child vaccination policies in Europe: a report from the Summits of Independent European Vaccination Experts. Lancet Infect Dis 2003; 3: 103-8.
12. Recommendations of the Advisory Committee on Immunization Practices (ACIP) Update: Vaccine Side-Effects, Adverse Reactions, Contraindications, and Precautions Recommendations of the Advisory Committee on Immunization Practices (ACIP). Morb Mortal Wkly Rep 1996; 45: 1-35.
13. van Savage J, Decker MD, Edwards KM, Sell SH, Karzon DT. Natural history of pertussis antibody in the infant and effect on vaccine response. J Infect Dis 1990; 161: 487-92.
14. Rappuoli R, Locht C, Poolman J, Andre F, Dougan G. European Commission COST/STD Initiative, Report of the Expert Panel VIII. New vaccines, especially new combined vaccines. Vaccine 1996; 14: 691-700.
15. Meyerhoff A, Weniger B, Jacobs RJ. Economic value to parents of reducing the pain and emotional distress of childhood vaccine injections. Pediatr Infect Dis J 2001; 20(Suppl 1): S57-62.
16. Avdicová M, Prikazsky V, Hudeckova H, Schuerman L, Willems P. Immunogenicity and reactogenicity of a novel hexavalent DTPa-HBV-IPV/Hib vaccine compared to separate concomitant injections of DTPa-IPV/Hib and HBV vaccines, when administered according to a 3, 5 and 11 month vaccination schedule. Eur J Pediatr 2002; 161: 581-7.
17. Taranger J, Trollfors B, Knutsson N, Sundh V, Lagergaerd T, Estergaard E. Vaccination of infants with a 4-dose and a 3-dose vaccination schedule. Vaccine 2000; 18: 884-91.
18. Carlsson R-M, Claesson BA, Selstam U, Fagerlund E, Granström M, Blondeau C. Safety and immunogenicity of a combined diphtheria-tetanus-acellular pertussis-inactivated polio vaccine-Haemophilus influenzae type b vaccine administered at 2, 4, 6, 13 or 3, 5, 12 months of age, Pediatr. Infect Dis J 1998; 17: 1026-33.
19. Eskola J, Olander R-M, Hovi T, Litmanen L, Peltola S, Kayhty H. Randomized trial of the effect of co-administration with acellular pertussis DTP vaccine on immunogenecity of Haemophilus influenzae type conjugate vaccine. Lancet 1996; 348: 1688-92.
20. Pichichero ME, Passador S. Administration of combined diphtheria and tetanus toxoids and pertussis vaccine, hepatitis B vaccine, and Haemophilus influenzae type b (Hib) vaccine to infants and response to a booster dose of Hib conjugate vaccine. Clin Infect Dis 1997; 25: 1378-84.
21. Bell F, Heath P, Shackley F, MacLennan J, Shearstone N, Diggle L, et al. Effect of combination with an acellular pertussis, diphtheria, tetanus vaccine on antibody response to Hib vaccine (PRP-T). Vaccine 1998; 16: 637-42.
22. Eskola J, Ward J, Dagan R, Goldblatt D, Zepp F, Siegrist CA. Combined vaccination of Haemophilus influenzae type b conjugate and diphtheria-tetanus-pertussis containing acellular pertussis. Lancet 1999; 354: 2063-8.
23. Halperin SA, King J, Law B, Mills E, Willems P. Safety and immunogenicity of Haemophilus influenzae-tetanus toxoid conjugate vaccine given separately or in combination with a 3-component acellular pertussis vaccine combined with diphtheria and tetanus toxoids and inactivated poliovirus vaccine for the first 4 doses. Clin Infect Dis 1999; 28: 995-1001.
24. Poolman J, Kaufhold A, De Grave D, Goldblatt D. Clinical relevance of lower Hib response in DTPa-based combination vaccines. Vaccine 2001; 19: 2280-5.
25. Mäkelä PH, Käyhty H. Evolution of conjugate vaccines. Expert Rev Vaccines 2002; 1: 399-410.
26. Sänger R, the German 095-study group, Mächler G, Meurice F, Schuerman L Persistence of antibodies in children primed with 2 different hexavalent diphtheria-tetanus-acellular pertussis-HBV-IPV-Hib vaccines and evaluation of booster vaccination. ESPID 2004, Tampere, Finland.