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; received in revised form 28 November 2006; accepted 2 February 2007.

Objective

To evaluate the immunogenicity and safety of a diphtheria and tetanus toxoids, acellular pertussis, hepatitis B, and inactivated poliovirus-containing vaccine (DTaP-HepB-IPV) coadministered with pneumococcal 7-valent conjugate vaccine (PCV-7) and Haemophilus influenzae type b vaccine (Hib), with separate vaccines concurrently, or staggered (delayed) administration of PCV-7.

Study design

At 2, 4, and 6 months of age, infants received either DTaP-HepB-IPV plus PCV-7 and Hib (n = 199), separate vaccines (n = 188), or DTaP-HepB-IPV plus Hib with PCV-7 administered 2 weeks later (n = 188). Blood was drawn before and after vaccination. Parents reported symptoms for 4 days after each dose and adverse events throughout the entire study.

Results

Immunogenicity in the Combination Vaccine Group was noninferior to that of the Separate and Staggered Vaccine Groups with respect to seroprotective rates for diphtheria, tetanus, and poliovirus and to geometric mean concentrations for pertussis. Seroprotective rates for HepB and Hib were not different between groups. Seropositivity for PCV-7 was high in all groups. Administration of combination vaccine appeared to be associated with higher rates of irritability, fever ≥100.4°F (38.0°C) and some local symptoms compared with separate vaccines (exploratory P < .05). No group differences were observed in rates of symptoms for which parents sought medical advice.

Conclusions

DTaP-HepB-IPV was highly immunogenic and well tolerated when coadministered with Hib and PCV-7 at 2, 4, and 6 months of age.

Abbreviations: ANCOVA, Analysis of covariance, CI, Confidence interval, DT, Diphtheria toxoid, DTaP, Diphtheria–tetanus–acellular pertussis vaccine, ELISA, Enzyme-linked immunosorbent assay, EL.U, ELISA units, FHA, Filamentous hemagglutinin, GMC, Geometric mean concentration, GMT, Geometric mean titer, HepB, Hepatitis B vaccine, HBsAg, Hepatitis B surface antigen, Hib, Haemophilus influenzae type b vaccine, IPV, Inactivated poliovirus vaccine, Lf, Limit of flocculation unit, PCV-7, Pneumococcal 7-valent conjugate vaccine, PRN, Pertactin, PRP, Polyribosylribitol, PT, Pertussis toxoid, TT, Tetanus toxoid

 

 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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