Tags

Type your tag names separated by a space and hit enter

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.
Pediatrics. 2008 Dec; 122(6):e1179-85.Ped

Abstract

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 61,004 infants who received >or=1 dose of vaccine (120000 total doses). This group was compared with a previous cohort of 58,251 age-, gender-, and medical center-matched infants (116,637 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.

Authors+Show Affiliations

UCLA Center for Vaccine Research, Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Los Angeles, CA, USA. kzangwill@labiomed.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Evaluation Study
Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19047220

Citation

Zangwill, Kenneth M., et al. "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." Pediatrics, vol. 122, no. 6, 2008, pp. e1179-85.
Zangwill KM, Eriksen E, Lee M, et al. 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. Pediatrics. 2008;122(6):e1179-85.
Zangwill, K. M., Eriksen, E., Lee, M., Lee, J., Marcy, S. M., Friedland, L. R., Weston, W., Howe, B., & Ward, J. I. (2008). 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. Pediatrics, 122(6), e1179-85. https://doi.org/10.1542/peds.2008-1977
Zangwill KM, et al. 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. Pediatrics. 2008;122(6):e1179-85. PubMed PMID: 19047220.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Zangwill,Kenneth M, AU - Eriksen,Eileen, AU - Lee,Martin, AU - Lee,Jennifer, AU - Marcy,S Michael, AU - Friedland,Leonard R, AU - Weston,Wayde, AU - Howe,Barbara, AU - Ward,Joel I, PY - 2008/12/3/pubmed PY - 2009/1/16/medline PY - 2008/12/3/entrez SP - e1179 EP - 85 JF - Pediatrics JO - Pediatrics VL - 122 IS - 6 N2 - 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 61,004 infants who received >or=1 dose of vaccine (120000 total doses). This group was compared with a previous cohort of 58,251 age-, gender-, and medical center-matched infants (116,637 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. SN - 1098-4275 UR - https://www.unboundmedicine.com/medline/citation/19047220/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_ L2 - http://pediatrics.aappublications.org/cgi/pmidlookup?view=long&pmid=19047220 DB - PRIME DP - Unbound Medicine ER -