Combination Vaccines: Postlicensure Safety Evaluation
نویسندگان
چکیده
منابع مشابه
Postlicensure safety surveillance for varicella vaccine.
CONTEXT Since its licensure in 1995, the extensive use of varicella vaccine and close surveillance of the associated anecdotal reports of suspected adverse effects provide the opportunity to detect potential risks not observed before licensure because of the relatively small sample size and other limitations of clinical trials. OBJECTIVES To detect potential hazards, including rare events, as...
متن کاملPrelicensure evaluation of combination vaccines.
There is considerable public health interest in licensing safe and effective combination vaccines. Because combination vaccines may progress rapidly from phase 1 to a pivotal phase 2 immunogenicity trial, a rigorous approach to address product issues early in development is warranted. Clinical studies to evaluate the safety, immunogenicity, and (when necessary) clinical end point efficacy of co...
متن کاملU.S. Postlicensure safety surveillance for adolescent and adult tetanus, diphtheria and acellular pertussis vaccines: 2005-2007.
BACKGROUND Pre-licensure clinical trials for two U.S. licensed tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccines did not reveal any major safety concerns. However, routine use in large adolescent and adult populations could reveal rare and potentially serious adverse events (AEs). METHODS To characterize reported AEs following Tdap vaccination and identify pote...
متن کاملInfluenza vaccines: Evaluation of the safety profile
The safety of vaccines is a critical factor in maintaining public trust in national vaccination programs. Vaccines are recommended for children, adults and elderly subjects and have to meet higher safety standards, since they are administered to healthy subjects, mainly healthy children. Although vaccines are strictly monitored before authorization, the possibility of adverse events and/or rare...
متن کاملPostlicensure safety surveillance for quadrivalent human papillomavirus recombinant vaccine.
CONTEXT In June 2006, the Food and Drug Administration licensed the quadrivalent human papillomavirus (types 6, 11, 16, and 18) recombinant vaccine (qHPV) in the United States for use in females aged 9 to 26 years; the Advisory Committee on Immunization Practices then recommended qHPV for routine vaccination of girls aged 11 to 12 years. OBJECTIVE To summarize reports to the Vaccine Adverse E...
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ژورنال
عنوان ژورنال: Clinical Infectious Diseases
سال: 2001
ISSN: 1058-4838,1537-6591
DOI: 10.1086/322569