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Short Report

Adaptation of a previously validated vaccination report card for use in adult vaccine clinical trials to align with the 2007 FDA Toxicity Grading Scale Guidance

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Pages 1208-1212 | Received 19 Apr 2012, Accepted 08 Jul 2012, Published online: 21 Aug 2012

References

  • Coplan P, Chiacchierini L, Nikas A, Shea J, Baumritter A, Beutner K, et al. Development and evaluation of a standardized questionnaire for identifying adverse events in vaccine clinical trials. Pharmacoepidemiol Drug Saf 2000; 9:457 - 71; http://dx.doi.org/10.1002/1099-1557(200011)9:6<457::AID-PDS529>3.0.CO;2-R; PMID: 19025852
  • Sutradhar SC, Wang WWB, Schlienger K, Stek JE, Xu J, Chan ISF, et al. Comparison of the levels of immunogenicity and safety of Zostavax in adults 50 to 59 years old and in adults 60 years old or older. Clin Vaccine Immunol 2009; 16:646 - 52; http://dx.doi.org/10.1128/CVI.00407-08; PMID: 19261769
  • Tyring SK, Diaz-Mitoma F, Padget LG, Nunez M, Poland G, Cassidy WM, et al, Protocol 009 Study Group. Safety and tolerability of a high-potency zoster vaccine in adults >/= 50 or years of age. Vaccine 2007; 25:1877 - 83; http://dx.doi.org/10.1016/j.vaccine.2006.10.027; PMID: 17227688
  • Kerzner B, Murray AV, Cheng E, Ifle R, Harvey PR, Tomlinson M, et al. Safety and immunogenicity profile of the concomitant administration of ZOSTAVAX and inactivated influenza vaccine in adults aged 50 and older. J Am Geriatr Soc 2007; 55:1499 - 507; http://dx.doi.org/10.1111/j.1532-5415.2007.01397.x; PMID: 17908055
  • Vermeulen JN, Lange JM, Tyring SK, Peters PH, Nunez M, Poland G, et al. Safety, tolerability, and immunogenicity after 1 and 2 doses of zoster vaccine in healthy adults ≥60 years of age. Vaccine 2012; 30:904 - 10; http://dx.doi.org/10.1016/j.vaccine.2011.11.096; PMID: 22154769
  • Harro CD, Robertson MN, Lally MA, O'Neill LD, Edupuganti S, Goepfert PA, et al. Safety and immunogenicity of adenovirus-vectored near-consensus HIV type 1 clade B gag vaccines in healthy adults. AIDS Resear Hum Retro 2009; 25:1 - 12
  • Priddy FH, Brown D, Kublin J, Monahan K, Wright DP, Lalezari J, et al, Merck V520-016 Study Group. Safety and immunogenicity of a replication-incompetent adenovirus type 5 HIV-1 clade B gag/pol/nef vaccine in healthy adults. Clin Infect Dis 2008; 46:1769 - 81; http://dx.doi.org/10.1086/587993; PMID: 18433307
  • Vesikari T, Van Damme P, Lindblad N, Pfletschinger U, Radley D, Ryan D, et al. An open-label, randomized, multicenter study of the safety, tolerability, and immunogenicity of quadrivalent human papillomavirus (types 6/11/16/18) vaccine given concomitantly with diphtheria, tetanus, pertussis, and poliomyelitis vaccine in healthy adolescents 11 to 17 years of age. Pediatr Infect Dis J 2010; 29:314 - 8; PMID: 19952980
  • Levin MJ, Moscicki AB, Song LY, Fenton T, Meyer WA 3rd, Read JS, et al, IMPAACT P1047 Protocol Team. Safety and immunogenicity of a quadrivalent human papillomavirus (types 6, 11, 16, and 18) vaccine in HIV-infected children 7 to 12 years old. J Acquir Immune Defic Syndr 2010; 55:197 - 204; http://dx.doi.org/10.1097/QAI.0b013e3181de8d26; PMID: 20574412
  • Arguedas A, Soley C, Loaiza C, Rincon G, Guevara S, Perez A, et al. Safety and immunogenicity of one dose of MenACWY-CRM, an investigational quadrivalent meningococcal glycoconjugate vaccine, when administered to adolescents concomitantly or sequentially with Tdap and HPV vaccines. Vaccine 2010; 28:3171 - 9; http://dx.doi.org/10.1016/j.vaccine.2010.02.045; PMID: 20189491
  • Food and Drug Administration. Guidance for Industry: toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical. http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/ucm091977.pdf [accessed December 2011].

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