Published online December 1, 2008
PEDIATRICS Vol. 122 No. 6 December 2008, pp. e1179-e1185 (doi:10.1542/10.1542/peds.2008-1977)
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ARTICLE

A Population-Based, Postlicensure Evaluation of the Safety of a Combination Diphtheria, Tetanus, Acellular Pertussis, Hepatitis B, and Inactivated Poliovirus Vaccine in a Large Managed Care Organization

Kenneth M. Zangwill, MDa, Eileen Eriksen, MPHa, Martin Lee, PhDa, Jennifer Lee, MSa, S. Michael Marcy, MDa,b, Leonard R. Friedland, MDc, Wayde Weston, PhDc, Barbara Howe, MDc and Joel I. Ward, MDa

a UCLA Center for Vaccine Research, Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Los Angeles, California
b Southern California Kaiser Permanente Health Care Plan, Los Angeles, California
c GlaxoSmithKline Biologicals, King of Prussia, Pennsylvania

BACKGROUND. Prelicensure studies of diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated polio virus vaccine suggested that there were higher rates of fever after its administration than when its component antigens were given separately.

METHODS. We conducted an open, controlled, cohort study to evaluate selected potential adverse events after receipt of diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus vaccine in the Southern California Kaiser Permanente Health Care Plan. From April 2003 through June 2005, we identified 61004 infants who received ≥1 dose of vaccine (120000 total doses). This group was compared with a previous cohort of 58251 age-, gender-, and medical center–matched infants (116637 doses) who received diphtheria, tetanus, acellular pertussis vaccine and separate doses of hepatitis B and inactivated poliovirus vaccines from January 2002 through March 2003. We compared the incidence of seizures, medically attended events that were associated with fever, and other selected adverse outcomes.

RESULTS. We identified 16 infants (8 with fever) who had a seizure in the diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus cohort and 15 infants (6 with fever) among control subjects in the 8-day period after receipt of any dose of vaccine. The incidence of all seizures or seizures associated with fever was not significantly different between cohorts. The incidence of medically attended events that were associated with fever in the 4-day period after any dose of vaccine was also similar in both cohorts. As well, no significant differences between the diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and control cohorts, were noted in the incidence of allergic reactions within 48 hours of any dose of vaccine, outpatient visits within 21 days, hospitalizations within 21 days, or death within 1 year.

CONCLUSIONS. We did not observe a statistically significant increase in any of several clinically important safety events after diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus vaccination compared with a historical cohort who received separate component vaccines.

Key Words: vaccine safety • DTaP-HepB-IPV vaccine

Abbreviations: DTaP-HepB-IPV—diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus • SCKP—Southern California Kaiser Permanente Health Care Plan • PCV—pneumococcal conjugate vaccine • MAEF—medically attended event associated with fever • ICD-9—International Classification of Diseases, Ninth Revision • CI—confidence interval

Accepted Sep 2, 2008.


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