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Items: 1 to 20 of 118

1.

Optimal approaches to data collection and analysis of potential immune mediated disorders in clinical trials of new vaccines.

Tavares Da Silva F, De Keyser F, Lambert PH, Robinson WH, Westhovens R, Sindic C.

Vaccine. 2013 Apr 3;31(14):1870-6. doi: 10.1016/j.vaccine.2013.01.042. Epub 2013 Feb 4.

2.

Surveillance for safety after immunization: Vaccine Adverse Event Reporting System (VAERS)--United States, 1991-2001.

Zhou W, Pool V, Iskander JK, English-Bullard R, Ball R, Wise RP, Haber P, Pless RP, Mootrey G, Ellenberg SS, Braun MM, Chen RT.

MMWR Surveill Summ. 2003 Jan 24;52(1):1-24. Erratum in: MMWR Morb Mortal Wkly Rep. 2003 Feb 14;52(06):113.

3.

Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines.

Verstraeten T, Descamps D, David MP, Zahaf T, Hardt K, Izurieta P, Dubin G, Breuer T.

Vaccine. 2008 Dec 2;26(51):6630-8. doi: 10.1016/j.vaccine.2008.09.049.

PMID:
18845199
4.

Safety considerations for new vaccine development.

Ellenberg SS.

Pharmacoepidemiol Drug Saf. 2001 Aug-Sep;10(5):411-5.

PMID:
11802587
5.

The Brighton Collaboration: addressing the need for standardized case definitions of adverse events following immunization (AEFI).

Bonhoeffer J, Kohl K, Chen R, Duclos P, Heijbel H, Heininger U, Jefferson T, Loupi E.

Vaccine. 2002 Dec 13;21(3-4):298-302.

PMID:
12450705
6.

Reporting of vaccine safety data in publications: systematic review.

Bonhoeffer J, Zumbrunn B, Heininger U.

Pharmacoepidemiol Drug Saf. 2005 Feb;14(2):101-6. Review.

PMID:
15386705
8.

The measurement and monitoring of surgical adverse events.

Bruce J, Russell EM, Mollison J, Krukowski ZH.

Health Technol Assess. 2001;5(22):1-194. Review.

9.

Recommendations for safety planning, data collection, evaluation and reporting during drug, biologic and vaccine development: a report of the safety planning, evaluation, and reporting team.

Crowe BJ, Xia HA, Berlin JA, Watson DJ, Shi H, Lin SL, Kuebler J, Schriver RC, Santanello NC, Rochester G, Porter JB, Oster M, Mehrotra DV, Li Z, King EC, Harpur ES, Hall DB.

Clin Trials. 2009 Oct;6(5):430-40. doi: 10.1177/1740774509344101.

PMID:
19846894
10.

A systematic review of safety data reporting in clinical trials of vaccines against malaria, tuberculosis, and human immunodeficiency virus.

Tamminga C, Kavanaugh M, Fedders C, Maiolatesi S, Abraham N, Bonhoeffer J, Heininger U, Vasquez CS, Moorthy VS, Epstein JE, Richie TL.

Vaccine. 2013 Aug 2;31(35):3628-35. doi: 10.1016/j.vaccine.2013.01.045. Epub 2013 Feb 8. Review.

PMID:
23395586
11.

Comparison of the reactogenicity and immunogenicity of a split and a subunit-adjuvanted influenza vaccine in elderly subjects.

Squarcione S, Sgricia S, Biasio LR, Perinetti E.

Vaccine. 2003 Mar 7;21(11-12):1268-74.

PMID:
12559808
12.

Report of a US public health service workshop on hypotonic-hyporesponsive episode (HHE) after pertussis immunization.

Braun MM, Terracciano G, Salive ME, Blumberg DA, Vermeer-de Bondt PE, Heijbel H, Evans G, Patriarca PA, Ellenberg SS.

Pediatrics. 1998 Nov;102(5):E52.

PMID:
9794982
13.

MF59-adjuvanted versus non-adjuvanted influenza vaccines: integrated analysis from a large safety database.

Pellegrini M, Nicolay U, Lindert K, Groth N, Della Cioppa G.

Vaccine. 2009 Nov 16;27(49):6959-65. doi: 10.1016/j.vaccine.2009.08.101. Epub 2009 Sep 12.

PMID:
19751689
14.

An analysis of rotavirus vaccine reports to the vaccine adverse event reporting system: more than intussusception alone?

Haber P, Chen RT, Zanardi LR, Mootrey GT, English R, Braun MM; VAERS Working Group.

Pediatrics. 2004 Apr;113(4):e353-9.

PMID:
15060267
15.
16.

Application of the immunological disease continuum to study autoimmune and other inflammatory events after vaccination.

Koenig HC, Sutherland A, Izurieta HS, McGonagle D.

Vaccine. 2011 Jan 29;29(5):913-9. doi: 10.1016/j.vaccine.2010.10.044. Epub 2010 Oct 29. Review.

PMID:
21036134
17.

Natalizumab for relapsing remitting multiple sclerosis.

Pucci E, Giuliani G, Solari A, Simi S, Minozzi S, Di Pietrantonj C, Galea I.

Cochrane Database Syst Rev. 2011 Oct 5;(10):CD007621. doi: 10.1002/14651858.CD007621.pub2. Review.

PMID:
21975773
18.

Understanding the role of human variation in vaccine adverse events: the Clinical Immunization Safety Assessment Network.

LaRussa PS, Edwards KM, Dekker CL, Klein NP, Halsey NA, Marchant C, Baxter R, Engler RJ, Kissner J, Slade BA.

Pediatrics. 2011 May;127 Suppl 1:S65-73. doi: 10.1542/peds.2010-1722J. Epub 2011 Apr 18.

PMID:
21502239
19.

The path to a successful vaccine adjuvant--'the long and winding road'.

O'Hagan DT, De Gregorio E.

Drug Discov Today. 2009 Jun;14(11-12):541-51. doi: 10.1016/j.drudis.2009.02.009. Epub 2009 Mar 5. Review.

PMID:
19508916
20.

Oral vaccines for preventing cholera.

Sinclair D, Abba K, Zaman K, Qadri F, Graves PM.

Cochrane Database Syst Rev. 2011 Mar 16;(3):CD008603. doi: 10.1002/14651858.CD008603.pub2. Review.

PMID:
21412922

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