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7/12/2018 4:18 PM 744588 A SAFETY STUDY OF GARDASIL 9 IN PRISM-SENTINEL USING SEQUENTIAL ANALYSIS version 2; 27-Sep-2017 - Sentinel (FDA).pdf
7/12/2018 4:18 PM 86261 Approved Products _ Background on PCV.pdf
7/12/2018 4:18 PM 97530 Approved Products _ Information for Parents and Caregivers - presence PCV1 in Rotarix and DNA from PCV1 and PCV2 in RotaTeq..pdf
7/12/2018 4:18 PM 104982 Approved Products _ RotaTeq (Rotavirus Vaccine) Questions and Answers.pdf
7/12/2018 4:18 PM 102074 Approved Products _ Update on Rotavirus Vaccine.pdf
7/12/2018 4:18 PM 147498 Approved Products _ Update_ Information on Rotarix - Labeling Revision Pertaining to Intussusception.pdf
7/12/2018 4:18 PM 439079 ASSESSMENT OF FEBRILE SEIZURES AFTER TRIVALENT INFLUENZA VACCINES DURING THE 2010-2011 INFLUENZA SEASON IN THE POST-LICENSURE RAPID IMMUNIZATION SAFETY MONITORING PROGRAM; 15-May-2014 Sentinel (FDA).pdf
7/12/2018 4:18 PM 97186 Biologics Post-Market Activities _ FDA Sentinel study finds no association between venous thromboembolism and Gardasil vaccination.pdf
7/12/2018 4:18 PM 1391726 DEVELOPING THE INFRASTRUCTURE TO CONDUCT SURVEILLANCE OF PREGNANCY OUTCOMES FOLLOWING VACCINATION - A PROJECT UTILIZING INFLUENZA VACCINES AND SPONTANEOUS ABORTION AS A USE CASE 26-Jan-2018 - Sentinel (FDA).pdf
7/12/2018 4:18 PM 511943 Estimated number of Tdap vaccines given during pregnancy ending in a liveborn delivery and during the delivery visit from January 1, 2010 to September 30, 2015; 2-Nov-2016 Sentinel (FDA).pdf
7/12/2018 4:18 PM 606104 EVALUATION OF HPV9 (GARDASIL 9) VACCINE SAFETY SURVEILLANCE USING THE TREESCAN DATA MINING METHOD; 30-Jun-2016 Sentinel (FDA).pdf
7/12/2018 4:18 PM 716491 EVALUATION OF THE RISK OF VENOUS THROMBOEMBOLISM AFTER GARDASIL VACCINATION; 23-Apr-2015 Sentinel (FDA).pdf
7/12/2018 4:18 PM 13568 FDA & CDC Temporarily Suspend Use of Rotarix.pdf
7/12/2018 4:18 PM 89735 FDA - Background on Rotavirus.pdf
10/1/2017 4:46 PM 56450 FDA approval letter to Merck - include Henoch-Schonlein purpua and acute hemorrhagic edema of infancy-nr_STN 101069-5650 Approval LTR.pdf
7/12/2018 4:18 PM 117628 FDA Background on Rotavirus Vaccines.pdf
7/12/2018 4:18 PM 106418 FDA Background on Viral Vaccine Development.pdf
7/12/2018 4:18 PM 107951 FDA PRISM study demonstrates no statistically significant association between Trivalent Inactivated Influenza Vaccine and Febrile Seizures in Children during 2010-2011 season.pdf
10/17/2017 10:36 PM 54291 FDA_Guidance for Industry_Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications.pdf
10/17/2017 10:05 PM 59016 FDA_Guidance for Industry_General Principles for the Development of Vaccines to Protect Against Global Infectious Diseases Dec 2011.pdf
10/17/2017 10:04 PM 51529 FDA_POINTS TO CONSIDER ON PLASMID DNA VACCINES FOR PREVENTIVE INFECTIOUS DISEASE INDICATIONS_December 1996.pdf
10/17/2017 10:31 PM 648362 FDA_TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES ADVISORY COMMITTEE - VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE_JULY 27,200O.pdf
7/12/2018 4:18 PM 319468 Guidance for Industry- Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications.pdf
7/12/2018 4:18 PM 732814 History and Characterization of the Vero Cell Line.pdf
7/12/2018 4:18 PM 248653 INFLUENZA VACCINES AND FEBRILE SEIZURES IN THE 2013-2014 AND 2014-2015 INFLUENZA SEASONS version 2; 1-Aug-2016 - Sentinel (FDA).pdf
7/12/2018 4:18 PM 638096 INFLUENZA VACCINES AND FEBRILE SEIZURES IN THE 2013-2014 AND 2014-2015 INFLUENZA SEASONS; 10-Nov-2017 - Sentinel (FDA).pdf
7/12/2018 4:18 PM 425658 INTUSSUSCEPTION RISK AFTER ROTAVIRUS VACCINATION IN U.S. INFANTS; 12-Jun-2013 Sentinel (FDA).pdf
7/12/2018 4:18 PM 400089 KAWASAKI DISEASE AND PCV13 VACCINE version 2; 16-Aug-2016 Sentinel (FDA).pdf
7/12/2018 4:18 PM 1062789 MINI-SENTINEL CBER-PRISM SURVEILLANCE ACCESSING THE FRESHEST FEASIBLE DATA FOR CONDUCTING ACTIVE INFLUENZA VACCINE SAFETY SURVEILLANCE; 8-Apr-2015 Sentinel (FDA).pdf
7/12/2018 4:18 PM 284881 MINI-SENTINEL CBER-PRISM SURVEILLANCE PROTOCOL ACCESSING THE FRESHEST FEASIBLE DATA FOR CONDUCTING ACTIVE INFLUENZA VACCINE SAFETY SURVEILLANCE version 3; 31-Dec-2013 Sentinel (FDA).pdf
7/12/2018 4:18 PM 334722 MINI-SENTINEL CBER-PRISM SURVEILLANCE PROTOCOL INFLUENZA VACCINES AND FEBRILE SEIZURES version 2; 25-Jan-2013 Sentinel (FDA).pdf
7/12/2018 4:18 PM 1732397 MINI-SENTINEL CBER-PRISM SURVEILLANCE PROTOCOL INFLUENZA VACCINES AND PREGNANCY OUTCOMES version 3; 30-Dec-2015 - Sentinel (FDA).pdf
7/12/2018 4:18 PM 453452 MINI-SENTINEL CBER-PRISM SURVEILLANCE PROTOCOL MONITORING FOR INTUSSUSCEPTION AFTER TWO ROTAVIRUS VACCINES BY THE PRISM PROGRAM version 2; 3-Apr-2012 Sentinel (FDA).pdf
7/12/2018 4:18 PM 662662 MINI-SENTINEL CBER-PRISM SURVEILLANCE PROTOCOL MONITORING FOR VENOUS THROMBOEMBOLISM AFTER GARDASIL VACCINATION version 2.1; 11-Nov-2014 Sentinel (FDA).pdf
7/12/2018 4:18 PM 507226 Mini-Sentinel Modular Program Report - Flu vaccine GBS seizures Part 1; 6-Nov-2012 Sentinel (FDA).pdf
7/12/2018 4:18 PM 708990 Mini-Sentinel Modular Program Report - Flu vaccine GBS seizures Part 2; 6-Nov-2012 Sentinel (FDA).pdf
7/12/2018 4:18 PM 1089941 Mini-Sentinel Modular Program Report - Pneumococcal Conjugate Vaccines and Kawasaki Disease; 21-Sep-2012 Sentinel (FDA).pdf
7/12/2018 4:18 PM 267264 Mini-Sentinel_Modular-Program-Report_to09y05_mpr_wp48_v01_Enrollment-HPV-vaccinations.xls
7/12/2018 4:18 PM 329157 Mini-Sentinel_Summary-Table-Report_PRY2_STR64_67_Occurrence-of-Selected-Vaccinations-1.xlsx
7/12/2018 4:18 PM 3965952 MS_Brief_Report_to09y05_str_wp37-39_v01.xls
7/12/2018 4:18 PM 787427 Pertussis cases in infants under six months of age from January 1, 2010 to September 30, 2015; 18-Aug-2016 Sentinel (FDA).pdf
7/12/2018 4:18 PM 1031659 Postlicensure Medical Product Safety Data-Mining - Power Calculations For Bernoulli Data; 22-Dec-2017 - Sentinel (FDA).pdf
7/12/2018 4:18 PM 548904 RAPID SURVEILLANCE CAPABILITY PROTOCOL 2017-18 SEASONAL INFLUENZA VACCINES SURVEILLANCE version 3; 6-Nov-2017 - Sentinel (FDA).pdf
7/12/2018 4:18 PM 110638 Safety & Availability (Biologics) _ FDA Releases Final Study Results of a Mini-Sentinel Postlicensure Observational Study of Rotavirus Vaccines and Intussusception.pdf
7/12/2018 4:18 PM 356306 Trends of Tetanus, Diphtheria, and Acellular Pertussis (Tdap) Vaccination during Pregnancy in the Sentinel System (26-Aug-2017).pdf
7/12/2018 4:18 PM 1580819 VACCINES ADMINISTERED IN PREGNANCY AND BIRTH OUTCOMES - A PROJECT TO DEVELOP DATA INFRASTRUCTURE AND DESIGN FRAMEWORK version 3; 20-Jan-2017 Sentinel (FDA).pdf