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Volumn 209, Issue SUPPL. 1, 2014, Pages

Clinical evaluation of pertussis vaccines: US food and drug administration regulatory considerations

Author keywords

pertussis vaccines; regulatory pathways; vaccine effectiveness

Indexed keywords

PERTUSSIS VACCINES; REGULATORY PATHWAYS; VACCINE EFFECTIVENESS;

EID: 84899008686     PISSN: 00221899     EISSN: 15376613     Source Type: Journal    
DOI: 10.1093/infdis/jit532     Document Type: Article
Times cited : (6)

References (14)
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    • 21 CFR §314.126. Adequate and wellcontrolled studies
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    • Code of Federal Regulations
  • 6
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    • Rockville, MD: US Food and Drug Administration, Center for Biologics Evaluation and Research, Accessed 16 September 2013
    • Guidance for industry: Clinical data needed to support the licensure of seasonal inactivated influenza vaccines. Rockville, MD: US Food and Drug Administration, Center for Biologics Evaluation and Research, 2007. http://www.fda.gov/BiologicsBloodVaccines/GuidanceCompliance RegulatoryInformation/Guidances/Vaccines/ucm074794.htm. Accessed 16 September 2013
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    • WHO meeting on case definition of pertussis, Geneva, 10-11 January 1991. Geneva, Switzerland: World Health Organization, 1991:4-5. http:// apps.who.int/iris/handle/10665/66921. Accessed 22 October 2013
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    • Güris D, Strebel PM, Bardenheier B, et al. Changing epidemiology of pertussis in the United States: Increasing reported incidence among adolescents and adults, 1990-1996. Clin Infect Dis 1999; 28:1230-7
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    • Association of childhood pertussis with receipt of 5 doses of pertussis vaccine by time since last vaccine dose, California, 2010
    • Misegades LK, Winter K, Harriman K, et al. Association of childhood pertussis with receipt of 5 doses of pertussis vaccine by time since last vaccine dose, California, 2010. JAMA 2012; 308:2126-32
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    • Misegades, L.K.1    Winter, K.2    Harriman, K.3
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    • Waning protection after fifth dose of acellular pertussis vaccine in children
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    • Waning immunity to pertussis following 5 doses of dtap
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* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.