The Journal of Pediatrics
Volume 149, Issue 5 , Pages 603-610.e1, November 2006

Safety of reduced-antigen-content tetanus–diphtheria–acellular pertussis vaccine in adolescents as a sixth consecutive dose of acellular pertussis–containing vaccine

  • Fred Zepp, MD

      Affiliations

    • Drs. Zepp, Knuf, and Habermehl have acted as consultants for GlaxoSmithKline/other pharmaceutical companies and have received travel grants or honoraria paid by healthcare companies within the past 3 years. None of the other authors in this paper have declared conflicts of interest.
    • Corresponding Author InformationReprint requests: Prof F. Zepp, Children’s Hospital, Johannes-Gutenberg-University, Langenbeckstrasse 1, 55101 Mainz, Germany.
    • ,
  • Markus Knuf, MD

      Affiliations

    • Drs. Zepp, Knuf, and Habermehl have acted as consultants for GlaxoSmithKline/other pharmaceutical companies and have received travel grants or honoraria paid by healthcare companies within the past 3 years. None of the other authors in this paper have declared conflicts of interest.
    • ,
  • Pirmin Habermehl, MD

      Affiliations

    • Drs. Zepp, Knuf, and Habermehl have acted as consultants for GlaxoSmithKline/other pharmaceutical companies and have received travel grants or honoraria paid by healthcare companies within the past 3 years. None of the other authors in this paper have declared conflicts of interest.
    • ,
  • Wilma Mannhardt-Laakmann, MD
    • ,
  • Barbara Howe, MD

      Affiliations

    • Drs Howe and Friedland are employees of GlaxoSmithKline and report ownership of equity or stock options.
    • ,
  • Leonard R. Friedland, MD

      Affiliations

    • Drs Howe and Friedland are employees of GlaxoSmithKline and report ownership of equity or stock options.

Children’s Hospital, Johannes Gutenberg University, Mainz, Germany; and GlaxoSmithKline Biologicals, King of Prussia, PA.

Received 21 November 2005; received in revised form 15 March 2006; accepted 9 June 2006.

Objective

The safety of a booster dose of a reduced-antigen-content tetanus–diphtheria–acellular pertussis (Tdap) vaccine was evaluated in adolescents previously vaccinated with five doses of acellular pertussis–containing vaccine.

Study design

Adolescents (n = 319) previously vaccinated with either 5 doses of diphtheria–tetanus–acellular pertussis (DTaP) (n = 193) or 4 doses of DTaP plus another acellular pertussis–containing vaccine received one dose each of Tdap and hepatitis A vaccine in a double-blinded, randomized, crossover trial. Rates of adverse events (AEs) after vaccination with Tdap versus hepatitis A and rates of local AEs among adolescents vaccinated with Tdap (sixth acellular pertussis–containing vaccine dose) versus rates in these same individuals after vaccination with their fifth DTaP dose were assessed.

Results

After Tdap, pain (63.6%), redness (51.7%), and swelling (41.4%) were the most frequently reported AEs. Large injection site swelling (swelling >100 mm, arm circumference increase >50 mm or diffuse swelling interfering with daily activities) occurred in three adolescents and resolved without sequelae. After the sixth dose of acellular pertussis–containing vaccine, adolescents reported more pain and less redness and swelling compared with incidences of these AEs reported when these same individuals received their fifth DTaP dose.

Conclusions

These results suggest that Tdap is well tolerated as a sixth consecutive dose of acellular pertussis–containing vaccine.

Abbreviations: AE, Adverse event, aP, Pediatric formulation of acellular pertussis vaccine, ap, Adolescent formulation of acellular pertussis vaccine, CDC, Centers for Disease Control and Prevention, DTaP, Diphtheria, tetanus, and acellular pertussis vaccine, DTP, Diphtheria, tetanus, and pertussis, DTwP, Diphtheria, tetanus, and whole-cell pertussis vaccine, IPV, Inactivated polio virus, Lf, Limit of flocculation unit, PT, Pertussis toxin, Tdap, Reduced-antigen-content tetanus, diphtheria, and acellular pertussis vaccine

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 Supported by GlaxoSmithKline Biologicals (study No. 100406).

 This clinical trial was registered at www.clinicaltrials.gov (No. NCT00263679).

PII: S0022-3476(06)00553-1

doi:10.1016/j.jpeds.2006.06.016

Refers to article:

  • Recommendation for an adolescent dose of tetanus and diphtheria toxoids and acellular pertussis vaccine: Reassurance for the future

    Scott A. Halperin
    The Journal of Pediatrics November 2006 (Vol. 149, Issue 5, Pages 589-591)

The Journal of Pediatrics
Volume 149, Issue 5 , Pages 603-610.e1, November 2006

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