PEDIARIX™: Clinical trials

Expert Review of Vaccines

Volumn 4, Issue 2, 2005, Pages 139-145

  Yeh, Sylvia H ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

Combination vaccine; Diphtheria; Hepatitis B; Immunogenicity; Pertussis; Poliovirus; Safety; Tetanus

Indexed keywords

DIPHTHERIA PERTUSSIS POLIOMYELITIS TETANUS HEPATITIS B VACCINE; DIPHTHERIA PERTUSSIS POLIOMYELITIS TETANUS VACCINE; DIPHTHERIA PERTUSSIS TETANUS VACCINE; DIPHTHERIA TOXOID; HEPATITIS B VACCINE; INACTIVATED VACCINE; IPOL; PEDIARIX; PERTUSSIS VACCINE; POLIOMYELITIS VACCINE; RECOMBINANT HEPATITIS B VACCINE; TETANUS TOXOID; UNCLASSIFIED DRUG; VACCINE;

ANOREXIA; ANTIBODY RESPONSE; BACTERIAL INFECTION; CHILD; CHILDHOOD DISEASE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIPHTHERIA; DRUG FORMULATION; DRUG INDICATION; DRUG SAFETY; ENZYME LINKED IMMUNOSORBENT ASSAY; ERYTHEMA; FEVER; HEPATITIS B; HUMAN; IMMUNOGENICITY; INFANT; INFANT DISEASE; INJECTION SITE REACTION; MAJOR CLINICAL STUDY; PAIN; PERTUSSIS; POLIOMYELITIS; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; RESTLESSNESS; REVIEW; SOMNOLENCE; TETANUS; TREATMENT OUTCOME; VACCINATION; VIRUS INFECTION; VOMITING; IMMUNOLOGY;

CLINICAL TRIALS; HUMANS; INFANT; VACCINES, COMBINED;

EID: 17144383637     PISSN: 14760584     EISSN: None     Source Type: Journal    
DOI: 10.1586/14760584.4.2.139     Document Type: Review

References (23)

1. Centers for Disease Control and Prevention. Ten great public health achievements: United States, 1900-1999. Morb. Mortal. Wkly Rep. 48, 241-243 (1999).
2. Centers for Disease Control and Prevention. Recommended childhood and adolescent immunization schedule - United States, 2005. Morb. Mortal. Wkly Rep. 53(51-52), Q1-Q3 (2005).
3. Insel RA. Potential alterations in immunogenicity by combining or simultaneously administering vaccine components. Ann. NY Acad. Sci. 754, 35-47 (1995).
4. Eskola J, Olander RM, Hovi T et al. Randomised trial of the effect of coadministration with acellular pertussis DTP vaccine on immunogenicity of Haemophilus influenzae type b conjugate vaccine. Lancet 348, 1688-1692 (1996).
5. Dagan R, Igbaria K, Piglansky L et al. Safety and immunogenicity of a combined pentavalent diphtheria, tetanus, acellular pertussis, inactivated poliovirus and Haemophilus influenzae type b-tetanus conjugate vaccine in infants, compared with a whole-cell pertussis pentavalent vaccine. Pediar. Infect. Dis. J. 16, 1113-1121 (1997).
6. Pichichero ME, Latiolais T, Bernstein DI et al. Vaccine antigen interactions after a combination diphtheria-tetanus toxoid-acellular pertussis/purified capsular polysaccharide of Haemophilus influenzae type b-tetanus toxoid vaccine in 2-, 4- and 6-month-old infants. Pediar. Infect. Dis. J. 16, 863-870 (1997).
7. Kovel A, Wald ER, Guerra N, Serrdy C, Meschievitz CK. Safety and immunogenicity of acellular diphtheria-tetanus-pertussis and Haemophilus conjugate vaccines given in combination or at separate injection sites. J. Pediar. 120, 84-87 (1992).
8. Davisson EO, Powell HM, MacFarlane JO et al. The preservation of poliomyelitis vaccine with stabilitized merthiolate. J. Lab. Clin. Med. 47, 8-19 (1956).
9. Pittman M. Instability of pertussis vaccine component in quadruple antigen vaccine: diphtheria and tetanus toxoids and pertussis and poliomyelitis vaccines. JAMA 181, 25-30 (1962).
10. Partridge S, Yeh SH. Clinical evaluation of a DTaP-HepB-IPV combined vaccine. Am. J. Managed Care 9(Suppl.), S13-S22 (2003).
11. Blatter MM, Resinger K, Bottenfield GW et al. Evaluation of the reactogenicity and immunogenicity of a new combined DTaP-HBV-IPV vaccine coadministered with Hib vaccine at 2, 4 and 6 months of age. Clin. Infect. Dis. 29, 1074 (1999).
12. Schmitt HJ, Knuf M, Ortiz E et al. 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. 137, 304-312 (2000).
13. Yeh SH, Ward JI, Partridge S et al. Safety and immunogenicity of a pentavalent diphtheria, tetanus, pertussis, hepatitis B and polio combination vaccine in infants. Pediatr. Infect. Dis. J. 20, 973-980 (2001).
14. Zepp F, Schuind A, Meyer C et al. Safety and reactogenicity of a novel DTPa-HBV-IPV combined vaccine given along with commercial Hib vaccines in comparison with separate concomitant administration of DTPa, Hib, and OPV vaccines in infants. Pediatrics 109, E58 (2002).
15. Glyca R, Glyca V, Benes O et al. A new DTaP-HBV-IPV vaccine coadministered with Hib, compared to a commercially available DTPw-IPV/Hib vaccine coadministered with HBV, given at 6, 10 and 14 weeks following HBV at birth. Vaccine 19, 825-833 (2001).
16. Usonis V, Bakasenas V. Does concomitant injection of a combined diphtheria-tetanus-acellular pertussis-hepatitis B virus-inactivated polio virus vaccine influence the reactogenicity and immunogenicity of commercial Haemophilus influenzae type b conjugate vaccines? Eur. J. Pediar. 158, 398-402 (1999).
17. Blackwelder WC. Similarity/equivalence trials for combination vaccines. Ann. NY Acad. Sci. 754, 321-328 (1995).
18. Centers for Disease Control and Prevention. Poliomyelitis prevention in the United States: updated recommendations of the Advisory Committee on Immunization practices (ACIP). Morb. Mortal. Wkly Rep. 49(RR-5), 1-22 (2000).
19. PEDIARIX™ Prescribing information, GlaxoSmithKline, August (2003).
20. Greenberg DP, Wong VK, Partridge S, Howe BJ, Ward JI. Safety and immunogenicity of a combination DTPa-hepatitis B vaccine (DTPa-HepB) administered in infants at 2, 4, and 6 months of age. Presented at the 35th Annual Meeting of the Infectious Diseases Socieity of America (IDSA), San Francisco, CA, September 1997. Clin. Infect. Dis. 25, 467 (1997).
21. Greenberg DP. Considerations for hepatitis B as part of a combination vaccine. Pediar. Infect. Dis. J. 20, S34-S39 (2001).
22. Feldman S. Interchangeability of vaccines. Pediar. Infect. Dis. J. 20, S23-S29 (2001).
23. Eskola J, Ward J, Dagan R et al. Combined vaccination of Haemophilus influenzae type b conjugate and diphtheria-tetanus-pertussis containing acellular pertussis. Lancet 354(9195), 2063-2068 (1999).