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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
- 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.
- Correspondence: Dr Michael E. Pichichero, University of Rochester Medical Center, 601 Elmwood Avenue, Box 672, Rochester, NY 14642.
Henry Bernstein, DO
- 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
- 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
- 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
- GlaxoSmithKline Biologicals, Rixensart, Belgium
- Brigitte Cheuvart, PhD, is an employee of GlaxoSmithKline.
Sandra J. Holmes, PhD, MHA
- 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
- Other members of the 085 Study Group are listed in the Appendix.

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

Study design. *For the separate administration group, HepB was not to be administered at 4 months of age to subjects who received a dose of hepatitis B vaccine before enrollment in this study. DTaP in

Study design. *For the separate administration group, HepB was not to be administered at 4 months of age to subjects who received a dose of hepatitis B vaccine before enrollment in this study. DTaP indicates diphtheria–tetanus–acellular pertussis vaccine; HepB, hepatitis B vaccine; Hib, H influenzae type b vaccine; IPV, inactivated poliovirus vaccine; mos, months; PCV-7, pneumococcal conjugate vaccine; wks = weeks.
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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

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