The Food and Drug Administration's Post-Licensure Rapid Immunization Safety Monitoring program: strengthening the federal vaccine safety enterprise von Nguyen, Michael, Ball, Robert, Midthun, Karen, Lieu, Tracy A.

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The US Food and Drug Administration's Sentinel Initiative: Expanding the horizons of medical product safety von Robb, Melissa A., Racoosin, Judith A., Sherman, Rachel E., Gross, Thomas P., Ball, Robert, Reichman, Marsha E., Midthun, Karen, Woodcock, Janet

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Karen Midthun von Midthun, Karen, Mullard, Asher

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Developing the Nation's Biosimilars Program von Kozlowski, Steven, Woodcock, Janet, Midthun, Karen, Behrman Sherman, Rachel

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Immunization-safety monitoring systems for the 2009 H1N1 monovalent influenza vaccination program von Salmon, Daniel A, Akhtar, Aysha, Mergler, Michelle J, Vannice, Kirsten S, Izurieta, Hector, Ball, Robert, Lee, Grace M, Vellozzi, Claudia, Garman, Patrick, Cunningham, Francesca, Gellin, Bruce, Koh, Howard, Lurie, Nicole

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Evaluating the Safety of New Vaccines: Summary of a Workshop von Ellenberg, Susan S, Foulkes, Mary A, Midthun, Karen, Goldenthal, Karen L

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Rotavirus vaccines: an overview von Midthun, K, Kapikian, A Z

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Global safety of vaccines: strengthening systems for monitoring, management and the role of GACVS von Autran, Brigitte, Asturias, Edwin J, Evans, Stephen, Hartigan-Go, Kenneth, Hussey, Gregory, John, T Jacob, Lambert, Paul-Henri, Law, Barbara, Midthun, Karen, Nohynek, Hanna, Salmaso, Stefania, Smith, Peter G, Zuber, Patrick LF, Bentsi-Enchill, Adwoa, Caric, Aleksandra, Pfeifer, Dina, Duclos, Philippe, Wood, David

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Getting the Science Right and Doing the Right Science in Vaccine Safety von Bernier, Roger, Midthun, Karen

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Human milk mucin inhibits rotavirus replication and prevents experimental gastroenteritis von YOLKEN, R. H, PETERSON, J. A, VONDERFECHT, S. L, FOUTS, E. T, MIDTHUN, K, NEWBURG, D. S

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Safety, Immunogenicity, and Protective Efficacy of One and Three Doses of the Tetravalent Rhesus Rotavirus Vaccine in Infants in Lima, Peru von Lanata, Claudio F., Midthun, Karen, Black, Robert E., Butron, Betzabe, Huapaya, Ana, Penny, Mary E., Ventura, Gladis, Gil, Ana, Jett-Goheen, Mary, Davidson, Bruce L.

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Safety and immunogenicity of live attenuated human–bovine (UK) reassortant rotavirus vaccines with VP7-specificity for serotypes 1, 2, 3 or 4 in adults, children and infants von Clements-Mann, Mary Lou, Makhene, Mamodikoe K, Mrukowicz, Jacek, Wright, Peter F, Hoshino, Yasutaka, Midthun, Karen, Sperber, Ellen, Karron, Ruth, Kapikian, Albert Z

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FDA senior management perspectives von Woodcock, Janet, Temple, Robert, Midthun, Karen, Schultz, Daniel, Sundlof, Stephen

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Enhancing public confidence in vaccines through independent oversight of postlicensure vaccine safety. Commentary von SALMON, Daniel A, MOULTON, Lawrence H, HALSEY, Neal A, BERNIER, Roger, MIDTHUN, Karen

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Genetic relatedness among human rotaviruses von Flores, Jorge, Perez-Schael, Irene, Boeggeman, Elizabeth, White, Laura, Perez, Mireya, Purcell, Robert, Hoshino, Yasutaka, Midthun, Karen, Chanock, Robert M., Kapikian, Albert Z.

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Reactogenicity and antigenicity of rhesus rotavirus vaccine (MMU-18006) in newborn infants in Venezuela von FLORES, JORGE, DAOUD, GEORGETTE, DAOUD, NAIMEH, PUIG, MIRIAM, MARTINEZ, MARBELIA, PEREZ-SCHAEL, IRENE, SHAW, ROBERT, GREENBERG, HARRY B, MIDTHUN, KAREN, KAPIKIAN, ALBERT Z

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Vaccination of Vaccinia-Naive Adults with Human Immunodeficiency Virus Type 1 gp160 Recombinant Vaccinia Virus in a Blinded, Controlled, Randomized Clinical Trial von Graham, Barney S., Belshe, Robert B., Clements, Mary Lou, Dolin, Raphael, Corey, Lawrence, Wright, Peter F., Gorse, Geoffrey J., Midthun, Karen, Keefer, Michael C., Roberts, Norbert J., Schwartz, David H., Agosti, Jan M., Fernie, Bruce F., Stablein, Donald M., Montefiori, David C., Lambert, John S., Hu, Shiu-Lok, Esterlitz, Joy R., Lawrence, Dale N., Koff, Wayne C.

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Independent Segregation of Two Antigenic Specificities (VP3 and VP7) Involved in Neutralization of Rotavirus Infectivity von Hoshino, Yasutaka, Sereno, Mitzi M., Midthun, Karen, Flores, Jorge, Kapikian, Albert Z., Chanock, Robert M.

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Safety and Immunogenicity of a Live Attenuated Hepatitis A Virus Vaccine in Seronegative Volunteers von Midthun, Karen, Ellerbeck, Edward, Gershman, Kenneth, Calandra, Gary, Krah, David, McCaughtry, Mary, Nalin, David, Provost, Philip

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Selected regulatory and scientific topics for candidate vaccine development von Henchal, Laraine S, Midthun, Karen, Goldenthal, Karen L

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