Adapting Group Sequential Methods to Observational Postlicensure Vaccine Safety Surveillance: Results of a Pentavalent Combination DTaP-IPV-Hib Vaccine Safety Study
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 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...
متن کاملPostlicensure safety surveillance for 7-valent pneumococcal conjugate vaccine.
CONTEXT Clinical trials evaluate a vaccine's safety before approval, but some risks may escape detection or adequate characterization until larger population exposures occur after licensure. OBJECTIVE To summarize reports of events occurring after vaccination with 7-valent pneumococcal conjugate vaccine (PCV), including those that may warrant further investigation to assess possible causation...
متن کاملThe Immunogenicity and Safety of a Combined DTaP-IPV//Hib Vaccine Compared with Individual DTaP-IPV and Hib (PRP~T) Vaccines: a Randomized Clinical Trial in South Korean Infants
Recommended infant vaccination in Korea includes DTaP-IPV and Hib vaccines administered as separate injections. In this randomized, open, controlled study we assessed the non-inferiority of immunogenicity of DTaP-IPV//Hib pentavalent combination vaccine (Pentaxim™) compared with licensed DTaP-IPV and Hib (PRP~T) vaccines. We enrolled 418 healthy Korean infants to receive either separate DTaP-IP...
متن کاملImmunogenicity and safety of a DTaP–IPV//PRP~T combination vaccine given with hepatitis B vaccine: a randomized open- label trial
Objective To determine seroprotection and vaccine response rates produced by a diphtheria–tetanus–acellular pertussis–inactivated poliovirus–Haemophilus influenzae type-b conjugate (DTaP–IPV//PRP~T) vaccine containing a polyribosyl-ribitol-phosphate (PRP)– tetanus toxoid conjugate (PentaximTM) and given with a hepatitis B vaccine. Methods In this multicentre open-label trial, 424 infants who re...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
ژورنال
عنوان ژورنال: American Journal of Epidemiology
سال: 2013
ISSN: 1476-6256,0002-9262
DOI: 10.1093/aje/kws317