Safety of Zostavax™-A cohort study in a managed care organization

Vaccine

Volumn 30, Issue 47, 2012, Pages 6636-6641

  Baxter, Roger ^a   Tran, Trung Nam ^b   Hansen, John ^a   Emery, Michael ^a   Fireman, Bruce ^a   Bartlett, Joan ^a   Lewis, Ned ^a   Saddier, Patricia ^b  

^a KAISER PERMANENTE   (United States)

^b MERCK RESEARCH LABORATORIES   (United States)

Author keywords

Safety; Shingles; Vaccine; Varicella; Zoster

Indexed keywords

VARICELLA ZOSTER VACCINE;

ACUTE HEART INFARCTION; ADULT; AGED; ARTICLE; CEREBROVASCULAR ACCIDENT; CEREBROVASCULAR DISEASE; CLINICAL ASSESSMENT; COHORT ANALYSIS; CONTROLLED STUDY; DRUG EFFICACY; DRUG SAFETY; EMERGENCY WARD; FEMALE; HERPES ZOSTER; HOSPITALIZATION; HUMAN; INCIDENCE; MAJOR CLINICAL STUDY; MALE; MANAGED CARE ORGANIZATION; MEDICAL CARE; MEDICAL EXPERT; MEDICAL RECORD REVIEW; OBSERVATIONAL STUDY; PRIORITY JOURNAL; RETROSPECTIVE STUDY; RISK ASSESSMENT; RISK FACTOR; STATISTICAL SIGNIFICANCE; TREATMENT OUTCOME; UNITED STATES; VACCINATION;

AGED; AGED, 80 AND OVER; CALIFORNIA; COHORT STUDIES; FEMALE; HERPES ZOSTER; HERPES ZOSTER VACCINE; HUMANS; MALE; MANAGED CARE PROGRAMS; MIDDLE AGED; PRODUCT SURVEILLANCE, POSTMARKETING; RETROSPECTIVE STUDIES; RISK ASSESSMENT; VACCINATION; VACCINES, ATTENUATED;

EID: 84867450705     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2012.08.070     Document Type: Article

References (22)

1. Hope-Simpson R.E. The nature of herpes zoster: a long-term study and a new hypothesis. Proc R Soc Med 1965, 58:9-20.
2. Brisson M., Edmunds W.J., Law B., Gay N.J., Walld R., Brownell M., et al. Epidemiology of varicella zoster virus infection in Canada and the United Kingdom. Epidemiol Infect 2001, 127(2):305-314.
3. Insinga R.P., Itzler R.F., Pellissier J.M., Saddier P., Nikas A.A. The incidence of herpes zoster in a United States administrative database. J Gen Intern Med 2005, 20(8):748-753.
4. Lin Y.H., Huang L.M., Chang I.S., Tsai F.Y., Lu C.Y., Shao P.L., et al. Disease burden and epidemiology of herpes zoster in pre-vaccine Taiwan. Vaccine 2010, 28(5):1217-1220.
5. Yawn B.P., Saddier P., Wollan P.C., St Sauver J.L., Kurland M.J., Sy L.S. A population-based study of the incidence and complication rates of herpes zoster before zoster vaccine introduction. Mayo Clin Proc 2007, 82(11):1341-1349.
6. Rimland D., Moanna A. Increasing incidence of herpes zoster among Veterans. Clin Infect Dis 2010, 50(7):1000-1005.
7. Gaillat J., Gajdos V., Launay O., Malvy D., Demoures B., Lewden L., et al. Does monastic life predispose to the risk of Saint Anthony's fire (herpes zoster)?. Clin Infect Dis 2011, 53(5):405-410.
8. Leung J., Harpaz R., Molinari N.A., Jumaan A., Zhou F. Herpes zoster incidence among insured persons in the United States, 1993-2006: evaluation of impact of varicella vaccination. Clin Infect Dis 2011, 52(3):332-340.
9. Oxman M.N., Levin M.J., Johnson G.R., Schmader K.E., Straus S.E., Gelb L.D., et al. A vaccine to prevent herpes zoster and postherpetic neuralgia in older adults. N Engl J Med 2005, 352(22):2271-2284.
10. Simberkoff M.S., Arbeit R.D., Johnson G.R., Oxman M.N., Boardman K.D., Williams H.M., et al. Safety of herpes zoster vaccine in the shingles prevention study: a randomized trial. Ann Intern Med 2010, 152(9):545-554.
11. Schmader K.E., Levin M.J., Gnann J.W., McNeil S.A., Vesikari T., Betts R.F., et al. Efficacy, safety, and tolerability of herpes zoster vaccine in persons aged 50-59 years. Clin Infect Dis 2012, 54(7):922-928.
12. Murray A.V., Reisinger K.S., Kerzner B., Stek J.E., Sausser T.A., Xu J., et al. Safety and tolerability of zoster vaccine in adults≥60 years old. Hum Vac 2011, 7(11):1130-1136.
13. Krieger N. Overcoming the absence of socioeconomic data in medical records: validation and application of a census-based methodology. Am J Public Health 1992, 82(5):703-710.
14. Kaiser permanente medical care program 2005, Wiley, New York. 4th ed. J.V.S.D. Selby, E.S. Johnson, M.A. Raebel, G.D. Friedman, B.H. McFarland (Eds.).
15. Gordon N.P. Similarity of the Adult Kaiser Permanente Membership in Northern California to the insured and general population in Northern California: statistics from the 2007 California Health Interview Survey 2012, Kaiser Permanente Division of Research, Oakland, CA.
16. Mareedu J., Hanumaiah R.G., Hale E., Habte-Gabr E. Varicella zoster vasculopathy. J Int Assoc Phys AIDS Care (Chic) 2011, 10(3):144-145.
17. Lorber A., Zonis Z., Maisuls E., Dembo L., Palant A., Iancu T.C. The scale of myocardial involvement in varicella myocarditis. Int J Cardiol 1988, 20(2):257-262.
18. Mehrotra D.V., Heyse J.F. Use of the false discovery rate for evaluating clinical safety data. Stat Methods Med Res 2004, 13(3):227-238.
19. Benjamini Y., Hochberg Y. Controlling the false discovery rate: a practical and powerful approach to multiple testing. J Royal Stat Soc Ser B 1995, 57:289-300.
20. Tseng H.F., Liu A., Sy L., Marcy S.M., Fireman B., Weintraub E., et al. Safety of zoster vaccine in adults from a large managed-care cohort: a vaccine safety datalink study. J Intern Med 2012.
21. Bartlett J., Fireman B., Hansen J., Klein N., Baxter R. Mortality after zostavax vaccination: evidence of selection bias. NFID Vaccine Research Conference 2010.
22. Brookhart M.A., Sturmer T., Glynn R.J., Rassen J., Schneeweiss S. Confounding control in healthcare database research: challenges and potential approaches. Med Care 2010, 48(6 Suppl):S114-S120.