The Journal of Pediatrics
Volume 151, Issue 1 , Pages 43-49.e2 , July 2007

Immunogenicity and Safety of a Combination Diphtheria, Tetanus Toxoid, Acellular Pertussis, Hepatitis B, and Inactivated Poliovirus Vaccine Coadministered with a 7-Valent Pneumococcal Conjugate Vaccine and a Haemophilus Influenzae Type b Conjugate Vaccine

  • Michael E. Pichichero, MD

      Affiliations

    • University of Rochester Medical Center, Rochester, New York
    • Michael E. Pichichero, MD, has received research grants and/or honoraria from GlaxoSmithKline, Sanofi Pasteur Inc, Wyeth, and Merck & Co, Inc, for vaccine-related research.
    • Corresponding Author InformationCorrespondence: Dr Michael E. Pichichero, University of Rochester Medical Center, 601 Elmwood Avenue, Box 672, Rochester, NY 14642.
    • ,
  • Henry Bernstein, DO

      Affiliations

    • Dartmouth Medical School, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire
    • Henry H. Bernstein, DO, has been a recipient of grant/research funding from GlaxoSmithKline.
    • ,
  • Mark M. Blatter, MD

      Affiliations

    • Primary Physicians Research, Pittsburgh, Pennsylvania
    • Mark M. Blatter, MD, serves on the Speakers’ Bureaus for Sanofi Pasteur, Inc, and GlaxoSmithKline. He has received grant/research funding from GlaxoSmithKline, Sanofi Pasteur, Inc, Wyeth, Merck & Co, Inc, MedImmune, Inc, and Chiron Corporation.
    • ,
  • Lode Schuerman, MD

      Affiliations

    • University of Rochester Medical Center, Rochester, New York
    • Dartmouth Medical School, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire
    • Primary Physicians Research, Pittsburgh, Pennsylvania
    • GlaxoSmithKline Biologicals, Rixensart, Belgium
    • formerly of Clinical/Medical Affairs, Vaccines-NA, GlaxoSmithKline, King of Prussia, Pennsylvania.
    • Lode Schuerman, MD, is an employee of GlaxoSmithKline and has stock options at the company.
    • ,
  • Brigitte Cheuvart, PhD

      Affiliations

    • GlaxoSmithKline Biologicals, Rixensart, Belgium
    • Brigitte Cheuvart, PhD, is an employee of GlaxoSmithKline.
    • ,
  • Sandra J. Holmes, PhD, MHA

      Affiliations

    • formerly of Clinical/Medical Affairs, Vaccines-NA, GlaxoSmithKline, King of Prussia, Pennsylvania.
    • Sandra J. Holmes, PhD, MHA, is a former employee of and previous consultant for GlaxoSmithKline.
    • ,
  • 085 Study Investigators

      Affiliations

    • Other members of the 085 Study Group are listed in the Appendix.

Received 4 August 2006 ,Revised 28 November 2006 ,Accepted 2 February 2007.

References 

  1. Centers for Disease Control and Prevention. Recommended childhood and adolescent immunization schedule: United States, 2006. MMWR Morb Mortal Wkly Rep. 2005;54(51/52):Q1–Q4
  2. Kalies H, Grote V, Verstraeten T, Hessel L, Schmitt HJ, von Kries R. The use of combination vaccines has improved timeliness of vaccination in children. Pediatr Infect Dis J. 2006;25:507–512
  3. Gylca R, Gylca V, Benes O, Melnic A, Chicu V, Weisbecker C, et al. 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;19:825–833
  4. 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 J. 2001;20:973–980
  5. Zepp F, Schuind A, Meyer C, Sänger R, Kaufhold A, Willems P. 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. 2002;109:e58
  6. Black S, Shinefield H, Fireman B, Lewis E, Ray P, Hansen JR, et al. Northern California Kaiser Permanente Vaccine Study Center Group Efficacy, safety and immunogenicity of heptavalent pneumococcal conjugate vaccine in children. Pediatr Infect Dis J. 2000;19:187–195
  7. Prevnar prescribing information. Philadelphia, Pa: Wyeth Pharmaceuticals, Inc; 2005;
  8. Newcombe RG. Interval estimation for the difference between independent proportions: comparison of eleven methods. Stat Med. 1998;17:873–890
  9. Clopper CJ, Pearson ES. The use of confidence or fiducial limits illustrated in the case of the binomial. Biometrika. 1934;26:404–413
  10. Schmitt HJ, Faber J, Lorenz I, Schmöle-Thoma B, Ahlers N. The safety, reactogenicity and immunogenicity of a 7-valent pneumococcal conjugate vaccine (7VPnC) concurrently administered with a combination DTaP-IPV-Hib vaccine. Vaccine. 2003;21:3653–3662
  11. Shinefield HR, Black S, Ray P, Chang IH, Lewis N, Fireman B, et al. Safety and immunogenicity of heptavalent pneumococcal CRM197 conjugate vaccine in infants and toddlers. Pediatr Infect Dis J. 1999;18:757–763
  12. Partridge S, Alvey J, Bernstein H, Blatter M, Bottenfield G, Guerrero J, et al. Safety of a combination diphtheria, tetanus toxoid, acellular pertussis, hepatitis b, and inactivated polio vaccine coadministered with a 7-valent pneumococcal conjugate vaccine and a Haemophilus influenzae type b conjugate vaccine. Vaccine. 2006;doi:10.1016/j.vaccine.2006.11.008.

 Supported by a grant from GlaxoSmithKline Biologicals, Rixensart, Belgium. Editorial support was provided by Scientific Therapeutics Information, Inc, Springfield, New Jersey.

 This trial is registered on the GlaxoSmithKline Clinical Trial Register (Study ID number 217744/085), available at: http://ctr.gsk.co.uk/Summary/Vaccine_Pediarix/studylist.asp.

 The study design and collection of the data were performed by GlaxoSmithKline. All analyses were performed at the University of Rochester, Rochester, New York (MEP Laboratories), except for the analysis of the anti-Streptococcus pneumoniae antibody, which was performed at the GlaxoSmithKline Laboratory in Rixensart, Belgium. Interpretation of data, writing of the manuscript, and decision to submit the paper for publication was made by the authors with contribution from GlaxoSmithKline. No form of payment was provided to any of the authors in conjunction with development of this manuscript.

PII: S0022-3476(07)00132-1

doi: 10.1016/j.jpeds.2007.02.013

The Journal of Pediatrics
Volume 151, Issue 1 , Pages 43-49.e2 , July 2007

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