17 results on '"Iyengar, Shalini"'
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2. Safety, immunogenicity, and efficacy of a COVID-19 vaccine (NVX-CoV2373) co-administered with seasonal influenza vaccines: an exploratory substudy of a randomised, observer-blinded, placebo-controlled, phase 3 trial
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Soiza, Roy L., Brittain-Long, Robin, Scicluna, Chiara, Edwards, Carole, Mackay, Lynn, D'Allesandro, Mariella, Nicol, Amy, Norris, Karen, Mann, Sandra, Lawrence, Heather, Valentine, Ruth, Viljoen, Marianne Elizabeth, Pretswell, Carol H., Nicholls, Helen, Munsoor, Imrozia, Meyrick, Agnieszka, Kyriakidou, Christina, Iyengar, Shalini, Jamal, Arham, Richards, Nick, Price, Helen, Rowbotham, Bridie, Bird, Danielle, Smith, Karen, Littler, Olga, Fielding, Kirsty, Townsend-Rose, Anna, Miller, Karen, Davis, Jessica, Elliot-Garwood, Alison, Trottier, Lauren, Edwards, Paul, McFarland, Margaret, Osanlou, Orod, Longshaw, Laura, Stockport, Jane, Grundy, Lynne, Broad, Katharine Lucy, Regan, Karen, Storton, Kim, Ryan-Wakeling, Declan, Wilson, Brad, Munisamy, Malathy, Wright, John, Shenoy, Anil, English, Beverley, Brear, Lucy, Cicconi, Paola, Boffito, Marta, Milinkovic, Ana, Byrne, Ruth, Movahedi, Roya, Housman, Rosalie, Kara, Naveed, Brown, Ellen, Cipriani, Andrea, Attenburrow, Mary-Jane, Smith, Katharine A., Packham, Jonathan, Sparrow, Geoff, Smith, Richard, Rosier, Josephine M., Saja, Khalid, Nago, Nyasha, Camilleri, Brian, Immanuel, Anita, Hamblin, Mike, Osagie, Rawlings, Mohan, Mahalakshmi, Floyd, Hilary, Goddard, Suzanne, Mutgi, Sanjay, Evans, John, McKeon, Sean, Vilimiene, Neringa, Chicano, Rosavic, Hayre, Rachel, Pandaan, Alice, Henshall, Catherine, Serrano, Sonia, Mazzella, Andrea, Rajeswaran, Thurkka, Mathew, Moncy, Bisnauthsing, Karen, Bremner, Laura, Fok, Henry, Morselli, Franca, Cinardo, Paola, Merrick, Blair, Sowole, Lucy, Broadhead, Samantha, Palmer, Natalie, Cordle, Jessica, Goldsmith, Jaimie Wilson, Cooney, Enya, Jackson, Beth, Jayatilleke, Thilina, Cheng, Zelda, Helliwell, Toby, Chudyk, Adrian, Giemza, Rafaela, Villajin, John Lord, Yogo, Noah, Makanju, Esther, Dulawan, Pearl, Nagra, Deepak, Buazon, April, Russell, Alice, Bird, Georgie, Heer, Amardeep, Sarmiento, Rex, Sanghera, Balraj, Mullin, Melanie, Champion, Adam, Bevan, Aisling, Iqbal, Kinzah, Johnson, Alshia, Clark, Rebecca, Shaw, Sarah, Shaw, Steven, Chalk, Amanda, Lovatt, Martin, Lillicrap, Caroline, Parker, Angela, Hansel, Jan, Wong, Zhi, Gan, Galvin, Tuma, Eyad, Minton, Jane, Murira, Jennifer, Saman, Razan, Hall, Alistair, Holliday, Kyra, Khan, Zara, Calderwood, James, Twigg, George, Baker, Helena, Corrigan, Julie, Houseman, Katy, Raguvanshi, Subhra, Heining, Dominic, Weddell, Jake, Glaves, Liz, Thompson, Kim, Davies, Francis, Lambley Burke, Ruth, Thomson, Emma C., Saralaya, Dinesh, Berry, Lisa, Hopewell, Nancy, Gerdes, Leigh, Pacurar, Mihaela, Faust, Saul N., Turner, Jeremy, Jeanes, Christopher, Cooper, Adele, Keshet-Price, Jocelyn, Coke, Lou, Cambell-Kelly, Melissa, Dhatariya, Ketan, Williams, Claire, Marks, Georgina, Sudbury, James, Rodolico, Lisa, Bradley, Judy, Carr, Sharon, Martin, Roisin, Madden, Angelina, Biagioni, Paul, McKenna, Sonia, Clinton, Alison, O'Kane, Maurice, Carter, Justin, Dewhurst, Matthew, Wetherill, Bill, Hoggarth, Thandiwe, Collins, Katrina Lennon, Chowdhury, Marie, Nathoo, Adil, Heinen, Anna, MacDonald, Orla, Hurducas, Claudia, Cifuentes, Liliana, Gill, Harjeevan, Gibson, Andy, West, Raha, Ewing, Jane, Blacow, Rachel, Haughney, John, MacDonald, Jonathan, Seenan, John Paul, Webb, Stewart, O'Leary, Colin, Muir, Scott, White, Beth, Ritchie, Neil, McAuley, Daniel F., Stewart, Jonathan, D'Alessandro, Mariella, Lakeman, Nicki, Purandare, Laura, Browne, Duncan, Tucker, David, Luck, Peter, Everden, Angharad, Trembath, Lisa, Visick, Michael, Morley, Nick, Reid, Laura, Chenoweth, Helen, Maclean, Kirsty, Sheridan, Ray P., Burden, Tom, Lunt, Craig Francis, Todd, Shirley, Estcourt, Stephanie, Pearce, Jasmine Marie, Wilkins, Suzanne, Love-Rouse, Cathryn, Torok-Pollok, Eva, Youle, Mike, Madge, Sara, Solomon, Danielle, Nandani, Aarti, North, Janet M., Hemat, Nargis, Newport, Rachel, Kalra, Philip A., Chukwu, Chukwuma, Wickens, Olivia, O'Loughlin, Vikki, Mistry, Hema, Harrison, Louise, Oliver, Robert, Peers, Anne-Marie, Zadik, Jess, Doyle, Katie, Chadwick, David R., Colling, Kerry, Wroe, Caroline, Branch, Marie, Chilvers, Alison, Essex, Sarah, Stone, Mark, San Francisco Ramos, Alberto, Beales, Emily, Bird, Olivia, Danos, Zsofia, Fofie, Hazel, Hultin, Cecilia, Ikram, Sabina, Mabesa, Fran, Mescall, Aoife, Pereira, Josyanne, Pearce, Jennifer, Sutton, Natalina, Snashall, Emma, Baxter, David Neil, Bennett, Sara, Suggitt, Debbie, Hughes, Kerry, Woodyatt, Wiesia, Beacon, Lynsey, Kent, Alissa, Cooper, Chris, Rudic, Milan, Tunstall, Simon, Jackson, Matthew, Hombersley, Claire, Moore, Patrick, Cutts, Rebecca, Higham, Andrew, Bukhari, Marwan, Elnaggar, Mohamed, Glover, Michelle, Richardson, Fiona, Dent, Alexandra, Mirza, Shahzeb, Ark, Rajiv, Han, Jennie, Hope, Suzy V., Mitchelmore, Philip J., Osanlou, Rostam, Freedman, Andrew, Cooper, Alison, Burton, Katherine, Katechia, Kashyap, Barrett, Michael, Salkeld, Jo, Hill, Natalie, Lee, Nathaniel, Perkins, Jon, Fox, Polly, Toback, Seth, Galiza, Eva, Cosgrove, Catherine, Galloway, James, Goodman, Anna L, Swift, Pauline A, Rajaram, Sankarasubramanian, Graves-Jones, Alison, Edelman, Jonathan, Burns, Fiona, Minassian, Angela M, Cho, Iksung, Kumar, Lakshmi, Plested, Joyce S, Rivers, E Joy, Robertson, Andreana, Dubovsky, Filip, Glenn, Greg, and Heath, Paul T
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- 2022
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3. THE PREDICTIVE ROLE OF SYMPTOMS IN COVID-19 DIAGNOSTIC MODELS – A LONGITUDINAL INSIGHT
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Bird, Olivia, primary, Galiza, Eva P., additional, Baxter, David Neil, additional, Boffito, Marta, additional, Browne, Duncan, additional, Burns, Fiona, additional, Chadwick, David R., additional, Clark, Rebecca, additional, Cosgrove, Catherine A., additional, Galloway, James, additional, Goodman, Anna L., additional, Heer, Amardeep, additional, Higham, Andrew, additional, Iyengar, Shalini, additional, Jeanes, Christopher, additional, Kalra, Philip A., additional, Kyriakidou, Christina, additional, Bradley, Judy M., additional, Munthali, Chigomezgo, additional, Minassian, Angela M., additional, McGill, Fiona, additional, Moore, Patrick, additional, Munsoor, Imrozia, additional, Nicholls, Helen, additional, Osanlou, Orod, additional, Packham, Jonathan, additional, Pretswell, Carol H., additional, San Francisco Ramos, Alberto, additional, Saralaya, Dinesh, additional, Sheridan, Ray P., additional, Smith, Richard, additional, Soiza, Roy L., additional, Swift, Pauline A., additional, Thomson, Emma C., additional, Turner, Jeremy, additional, Viljoen, Marianne Elizabeth, additional, Heath, Paul T., additional, and Chis Ster, Irina, additional
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- 2024
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4. Safety and Efficacy of the NVX-CoV2373 Coronavirus Disease 2019 Vaccine at Completion of the Placebo-Controlled Phase of a Randomized Controlled Trial
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Heath, Paul T, primary, Galiza, Eva P, additional, Baxter, David Neil, additional, Boffito, Marta, additional, Browne, Duncan, additional, Burns, Fiona, additional, Chadwick, David R, additional, Clark, Rebecca, additional, Cosgrove, Catherine A, additional, Galloway, James, additional, Goodman, Anna L, additional, Heer, Amardeep, additional, Higham, Andrew, additional, Iyengar, Shalini, additional, Jeanes, Christopher, additional, Kalra, Philip A, additional, Kyriakidou, Christina, additional, Bradley, Judy M, additional, Munthali, Chigomezgo, additional, Minassian, Angela M, additional, McGill, Fiona, additional, Moore, Patrick, additional, Munsoor, Imrozia, additional, Nicholls, Helen, additional, Osanlou, Orod, additional, Packham, Jonathan, additional, Pretswell, Carol H, additional, San Francisco Ramos, Alberto, additional, Saralaya, Dinesh, additional, Sheridan, Ray P, additional, Smith, Richard, additional, Soiza, Roy L, additional, Swift, Pauline A, additional, Thomson, Emma C, additional, Turner, Jeremy, additional, Viljoen, Marianne Elizabeth, additional, Fries, Louis, additional, Cho, Iksung, additional, McKnight, Irene, additional, Glenn, Greg, additional, Rivers, E Joy, additional, Robertson, Andreana, additional, Alves, Katia, additional, Smith, Kathy, additional, and Toback, Seth, additional
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- 2022
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5. Human rights and climate wrongs: Mapping the landscape of rights‐based climate litigation.
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Iyengar, Shalini
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HUMAN rights , *ACTIONS & defenses (Law) , *SOCIAL ecology , *CLIMATOLOGY , *LAWYERS - Abstract
Human rights‐based climate litigation cases have become increasingly prominent over the past decade. While absolute numbers of these cases are still relatively low, they have attracted significant praise and scrutiny, both from the standpoint of the media and the academy. However, while there is a large body of scholarly literature on these rights‐based climate cases, relatively little qualitative research has focused on the actors bringing these claims before the court. This article uses qualitative socio‐legal research methods to examine how lawyers and activists in the climate litigation space think about these cases, their strategies and their reasons for using human rights‐based arguments to address the climate crisis. By foregrounding these actors and their voices, this article tells the story of the human rights‐based climate litigation movement and how it came together. [ABSTRACT FROM AUTHOR]
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- 2023
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6. Safety and Efficacy of the NVX-CoV2373 Coronavirus Disease 2019 Vaccine at Completion of the Placebo-Controlled Phase of a Randomized Controlled Trial.
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Heath, Paul T, Galiza, Eva P, Baxter, David Neil, Boffito, Marta, Browne, Duncan, Burns, Fiona, Chadwick, David R, Clark, Rebecca, Cosgrove, Catherine A, Galloway, James, Goodman, Anna L, Heer, Amardeep, Higham, Andrew, Iyengar, Shalini, Jeanes, Christopher, Kalra, Philip A, Kyriakidou, Christina, Bradley, Judy M, Munthali, Chigomezgo, and Minassian, Angela M
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COVID-19 ,IMMUNOGLOBULINS ,CONFIDENCE intervals ,COVID-19 vaccines ,TIME ,CORONAVIRUS spike protein ,VACCINE effectiveness ,ANTIBODY formation ,SEVERITY of illness index ,INTERFERONS ,DESCRIPTIVE statistics ,RESEARCH funding ,T cells ,PATIENT safety ,SECONDARY analysis ,PHARMACODYNAMICS ,EVALUATION - Abstract
Background The recombinant protein-based vaccine, NVX-CoV2373, demonstrated 89.7% efficacy against coronavirus disease 2019 (COVID-19) in a phase 3, randomized, observer-blinded, placebo-controlled trial in the United Kingdom. The protocol was amended to include a blinded crossover. Data to the end of the placebo-controlled phase are reported. Methods Adults aged 18–84 years received 2 doses of NVX-CoV2373 or placebo (1:1) and were monitored for virologically confirmed mild, moderate, or severe COVID-19 (onset from 7 days after second vaccination). Participants who developed immunoglobulin G (IgG) against nucleocapsid protein but did not show symptomatic COVID-19 were considered asymptomatic. Secondary outcomes included anti-spike (S) IgG responses, wild-type virus neutralization, and T-cell responses. Results Of 15 185 participants, 13 989 remained in the per-protocol efficacy population (6989 NVX-CoV2373, 7000 placebo). At a maximum of 7.5 months (median, 4.5) postvaccination, there were 24 cases of COVID-19 among NVX-CoV2373 recipients and 134 cases among placebo recipients, a vaccine efficacy of 82.7% (95% confidence interval [CI], 73.3%–88.8%). Vaccine efficacy was 100% (95% CI, 17.9%–100.0%) against severe disease and 76.3% (95% CI, 57.4%–86.8%) against asymptomatic disease. High anti-S and neutralization responses to vaccination were evident, together with S-protein–specific induction of interferon-γ secretion in peripheral blood T cells. Incidence of serious adverse events and adverse events of special interest were similar between groups. Conclusions A 2-dose regimen of NVX-CoV2373 conferred a high level of ongoing protection against asymptomatic, symptomatic, and severe COVID-19 through >6 months postvaccination. A gradual decrease of protection suggests that a booster may be indicated. Clinical Trials Registration EudraCT, 2020-004123-16. [ABSTRACT FROM AUTHOR]
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- 2023
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7. Safety, immunogenicity, and efficacy of a COVID-19 vaccine (NVX-CoV2373) co-administered with seasonal influenza vaccines: an exploratory substudy of a randomised, observer-blinded, placebo-controlled, phase 3 trial
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Toback, Seth, primary, Galiza, Eva, additional, Cosgrove, Catherine, additional, Galloway, James, additional, Goodman, Anna L, additional, Swift, Pauline A, additional, Rajaram, Sankarasubramanian, additional, Graves-Jones, Alison, additional, Edelman, Jonathan, additional, Burns, Fiona, additional, Minassian, Angela M, additional, Cho, Iksung, additional, Kumar, Lakshmi, additional, Plested, Joyce S, additional, Rivers, E Joy, additional, Robertson, Andreana, additional, Dubovsky, Filip, additional, Glenn, Greg, additional, Heath, Paul T, additional, Soiza, Roy L., additional, Brittain-Long, Robin, additional, Scicluna, Chiara, additional, Edwards, Carole, additional, Mackay, Lynn, additional, D'Allesandro, Mariella, additional, Nicol, Amy, additional, Norris, Karen, additional, Mann, Sandra, additional, Lawrence, Heather, additional, Valentine, Ruth, additional, Viljoen, Marianne Elizabeth, additional, Pretswell, Carol H., additional, Nicholls, Helen, additional, Munsoor, Imrozia, additional, Meyrick, Agnieszka, additional, Kyriakidou, Christina, additional, Iyengar, Shalini, additional, Jamal, Arham, additional, Richards, Nick, additional, Price, Helen, additional, Rowbotham, Bridie, additional, Bird, Danielle, additional, Smith, Karen, additional, Littler, Olga, additional, Fielding, Kirsty, additional, Townsend-Rose, Anna, additional, Miller, Karen, additional, Davis, Jessica, additional, Elliot-Garwood, Alison, additional, Trottier, Lauren, additional, Edwards, Paul, additional, McFarland, Margaret, additional, Osanlou, Orod, additional, Longshaw, Laura, additional, Stockport, Jane, additional, Grundy, Lynne, additional, Broad, Katharine Lucy, additional, Regan, Karen, additional, Storton, Kim, additional, Ryan-Wakeling, Declan, additional, Wilson, Brad, additional, Munisamy, Malathy, additional, Wright, John, additional, Shenoy, Anil, additional, English, Beverley, additional, Brear, Lucy, additional, Cicconi, Paola, additional, Boffito, Marta, additional, Milinkovic, Ana, additional, Byrne, Ruth, additional, Movahedi, Roya, additional, Housman, Rosalie, additional, Kara, Naveed, additional, Brown, Ellen, additional, Cipriani, Andrea, additional, Attenburrow, Mary-Jane, additional, Smith, Katharine A., additional, Packham, Jonathan, additional, Sparrow, Geoff, additional, Smith, Richard, additional, Rosier, Josephine M., additional, Saja, Khalid, additional, Nago, Nyasha, additional, Camilleri, Brian, additional, Immanuel, Anita, additional, Hamblin, Mike, additional, Osagie, Rawlings, additional, Mohan, Mahalakshmi, additional, Floyd, Hilary, additional, Goddard, Suzanne, additional, Mutgi, Sanjay, additional, Evans, John, additional, McKeon, Sean, additional, Vilimiene, Neringa, additional, Chicano, Rosavic, additional, Hayre, Rachel, additional, Pandaan, Alice, additional, Henshall, Catherine, additional, Serrano, Sonia, additional, Mazzella, Andrea, additional, Rajeswaran, Thurkka, additional, Mathew, Moncy, additional, Bisnauthsing, Karen, additional, Bremner, Laura, additional, Fok, Henry, additional, Morselli, Franca, additional, Cinardo, Paola, additional, Merrick, Blair, additional, Sowole, Lucy, additional, Broadhead, Samantha, additional, Palmer, Natalie, additional, Cordle, Jessica, additional, Goldsmith, Jaimie Wilson, additional, Cooney, Enya, additional, Jackson, Beth, additional, Jayatilleke, Thilina, additional, Cheng, Zelda, additional, Helliwell, Toby, additional, Chudyk, Adrian, additional, Giemza, Rafaela, additional, Villajin, John Lord, additional, Yogo, Noah, additional, Makanju, Esther, additional, Dulawan, Pearl, additional, Nagra, Deepak, additional, Buazon, April, additional, Russell, Alice, additional, Bird, Georgie, additional, Heer, Amardeep, additional, Sarmiento, Rex, additional, Sanghera, Balraj, additional, Mullin, Melanie, additional, Champion, Adam, additional, Bevan, Aisling, additional, Iqbal, Kinzah, additional, Johnson, Alshia, additional, Clark, Rebecca, additional, Shaw, Sarah, additional, Shaw, Steven, additional, Chalk, Amanda, additional, Lovatt, Martin, additional, Lillicrap, Caroline, additional, Parker, Angela, additional, Hansel, Jan, additional, Wong, Zhi, additional, Gan, Galvin, additional, Tuma, Eyad, additional, Minton, Jane, additional, Murira, Jennifer, additional, Saman, Razan, additional, Hall, Alistair, additional, Holliday, Kyra, additional, Khan, Zara, additional, Calderwood, James, additional, Twigg, George, additional, Baker, Helena, additional, Corrigan, Julie, additional, Houseman, Katy, additional, Raguvanshi, Subhra, additional, Heining, Dominic, additional, Weddell, Jake, additional, Glaves, Liz, additional, Thompson, Kim, additional, Davies, Francis, additional, Lambley Burke, Ruth, additional, Thomson, Emma C., additional, Saralaya, Dinesh, additional, Berry, Lisa, additional, Hopewell, Nancy, additional, Gerdes, Leigh, additional, Pacurar, Mihaela, additional, Faust, Saul N., additional, Turner, Jeremy, additional, Jeanes, Christopher, additional, Cooper, Adele, additional, Keshet-Price, Jocelyn, additional, Coke, Lou, additional, Cambell-Kelly, Melissa, additional, Dhatariya, Ketan, additional, Williams, Claire, additional, Marks, Georgina, additional, Sudbury, James, additional, Rodolico, Lisa, additional, Bradley, Judy, additional, Carr, Sharon, additional, Martin, Roisin, additional, Madden, Angelina, additional, Biagioni, Paul, additional, McKenna, Sonia, additional, Clinton, Alison, additional, O'Kane, Maurice, additional, Carter, Justin, additional, Dewhurst, Matthew, additional, Wetherill, Bill, additional, Hoggarth, Thandiwe, additional, Collins, Katrina Lennon, additional, Chowdhury, Marie, additional, Nathoo, Adil, additional, Heinen, Anna, additional, MacDonald, Orla, additional, Hurducas, Claudia, additional, Cifuentes, Liliana, additional, Gill, Harjeevan, additional, Gibson, Andy, additional, West, Raha, additional, Ewing, Jane, additional, Blacow, Rachel, additional, Haughney, John, additional, MacDonald, Jonathan, additional, Seenan, John Paul, additional, Webb, Stewart, additional, O'Leary, Colin, additional, Muir, Scott, additional, White, Beth, additional, Ritchie, Neil, additional, McAuley, Daniel F., additional, Stewart, Jonathan, additional, D'Alessandro, Mariella, additional, Lakeman, Nicki, additional, Purandare, Laura, additional, Browne, Duncan, additional, Tucker, David, additional, Luck, Peter, additional, Everden, Angharad, additional, Trembath, Lisa, additional, Visick, Michael, additional, Morley, Nick, additional, Reid, Laura, additional, Chenoweth, Helen, additional, Maclean, Kirsty, additional, Sheridan, Ray P., additional, Burden, Tom, additional, Lunt, Craig Francis, additional, Todd, Shirley, additional, Estcourt, Stephanie, additional, Pearce, Jasmine Marie, additional, Wilkins, Suzanne, additional, Love-Rouse, Cathryn, additional, Torok-Pollok, Eva, additional, Youle, Mike, additional, Madge, Sara, additional, Solomon, Danielle, additional, Nandani, Aarti, additional, North, Janet M., additional, Hemat, Nargis, additional, Newport, Rachel, additional, Kalra, Philip A., additional, Chukwu, Chukwuma, additional, Wickens, Olivia, additional, O'Loughlin, Vikki, additional, Mistry, Hema, additional, Harrison, Louise, additional, Oliver, Robert, additional, Peers, Anne-Marie, additional, Zadik, Jess, additional, Doyle, Katie, additional, Chadwick, David R., additional, Colling, Kerry, additional, Wroe, Caroline, additional, Branch, Marie, additional, Chilvers, Alison, additional, Essex, Sarah, additional, Stone, Mark, additional, San Francisco Ramos, Alberto, additional, Beales, Emily, additional, Bird, Olivia, additional, Danos, Zsofia, additional, Fofie, Hazel, additional, Hultin, Cecilia, additional, Ikram, Sabina, additional, Mabesa, Fran, additional, Mescall, Aoife, additional, Pereira, Josyanne, additional, Pearce, Jennifer, additional, Sutton, Natalina, additional, Snashall, Emma, additional, Baxter, David Neil, additional, Bennett, Sara, additional, Suggitt, Debbie, additional, Hughes, Kerry, additional, Woodyatt, Wiesia, additional, Beacon, Lynsey, additional, Kent, Alissa, additional, Cooper, Chris, additional, Rudic, Milan, additional, Tunstall, Simon, additional, Jackson, Matthew, additional, Hombersley, Claire, additional, Moore, Patrick, additional, Cutts, Rebecca, additional, Higham, Andrew, additional, Bukhari, Marwan, additional, Elnaggar, Mohamed, additional, Glover, Michelle, additional, Richardson, Fiona, additional, Dent, Alexandra, additional, Mirza, Shahzeb, additional, Ark, Rajiv, additional, Han, Jennie, additional, Hope, Suzy V., additional, Mitchelmore, Philip J., additional, Osanlou, Rostam, additional, Freedman, Andrew, additional, Cooper, Alison, additional, Burton, Katherine, additional, Katechia, Kashyap, additional, Barrett, Michael, additional, Salkeld, Jo, additional, Hill, Natalie, additional, Lee, Nathaniel, additional, Perkins, Jon, additional, and Fox, Polly, additional
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- 2022
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8. Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine
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Heath, Paul T, Galiza, Eva P, Baxter, David N, Boffito, Marta, Browne, Duncan, Burns, Fiona, Chadwick, David R, Clark, Rebecca, Cosgrove, Catherine, Galloway, James, Goodman, Anna L, Heer, Amardeep, Higham, Andrew, Iyengar, Shalini, Jamal, Arham, Jeanes, Christopher, Kalra, Philip A, Kyriakidou, Christina, McAuley, Daniel F, Meyrick, Agnieszka, Minassian, Angela M, Minton, Jane, Moore, Patrick, Munsoor, Imrozia, Nicholls, Helen, Osanlou, Orod, Packham, Jonathan, Pretswell, Carol H, San Francisco Ramos, Alberto, Saralaya, Dinesh, Sheridan, Ray P, Smith, Richard, Soiza, Roy L, Swift, Pauline A, Thomson, Emma C, Turner, Jeremy, Viljoen, Marianne E, Albert, Gary, Cho, Iksung, Dubovsky, Filip, Glenn, Greg, Rivers, Joy, Robertson, Andreana, Smith, Kathy, Toback, Seth, 2019nCoV-302 Study Group, and Group, 2019nCoV-302 Study
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Adult ,2019-20 coronavirus outbreak ,COVID-19 Vaccines ,Coronavirus disease 2019 (COVID-19) ,Adolescent ,viruses ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,Injections, Intramuscular ,law.invention ,Young Adult ,Immunogenicity, Vaccine ,Randomized controlled trial ,SDG 3 - Good Health and Well-being ,law ,Medicine ,Humans ,Single-Blind Method ,Injections, Intramuscular/adverse effects ,Aged ,COVID-19/epidemiology ,COVID-19 Vaccines/administration & dosage ,Aged, 80 and over ,Vaccines, Synthetic ,Vaccines ,Vaccines, Synthetic/immunology ,business.industry ,SARS-CoV-2 ,Immunogenicity ,COVID-19 ,virus diseases ,General Medicine ,Middle Aged ,Clinical trial ,Immunology ,Original Article ,business ,Synthetic immunology - Abstract
BACKGROUND: Early clinical data from studies of the NVX-CoV2373 vaccine (Novavax), a recombinant nanoparticle vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that contains the full-length spike glycoprotein of the prototype strain plus Matrix-M adjuvant, showed that the vaccine was safe and associated with a robust immune response in healthy adult participants. Additional data were needed regarding the efficacy, immunogenicity, and safety of this vaccine in a larger population.METHODS: In this phase 3, randomized, observer-blinded, placebo-controlled trial conducted at 33 sites in the United Kingdom, we assigned adults between the ages of 18 and 84 years in a 1:1 ratio to receive two intramuscular 5-μg doses of NVX-CoV2373 or placebo administered 21 days apart. The primary efficacy end point was virologically confirmed mild, moderate, or severe SARS-CoV-2 infection with an onset at least 7 days after the second injection in participants who were serologically negative at baseline.RESULTS: A total of 15,187 participants underwent randomization, and 14,039 were included in the per-protocol efficacy population. Of the participants, 27.9% were 65 years of age or older, and 44.6% had coexisting illnesses. Infections were reported in 10 participants in the vaccine group and in 96 in the placebo group, with a symptom onset of at least 7 days after the second injection, for a vaccine efficacy of 89.7% (95% confidence interval [CI], 80.2 to 94.6). No hospitalizations or deaths were reported among the 10 cases in the vaccine group. Five cases of severe infection were reported, all of which were in the placebo group. A post hoc analysis showed an efficacy of 86.3% (95% CI, 71.3 to 93.5) against the B.1.1.7 (or alpha) variant and 96.4% (95% CI, 73.8 to 99.5) against non-B.1.1.7 variants. Reactogenicity was generally mild and transient. The incidence of serious adverse events was low and similar in the two groups.CONCLUSIONS: A two-dose regimen of the NVX-CoV2373 vaccine administered to adult participants conferred 89.7% protection against SARS-CoV-2 infection and showed high efficacy against the B.1.1.7 variant. (Funded by Novavax; EudraCT number, 2020-004123-16.).
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- 2021
9. Efficacy of the NVX-CoV2373 Covid-19 Vaccine Against the B.1.1.7 Variant
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Heath, Paul T., primary, Galiza, Eva P., additional, Baxter, David Neil, additional, Boffito, Marta, additional, Browne, Duncan, additional, Burns, Fiona, additional, Chadwick, David R., additional, Clark, Rebecca, additional, Cosgrove, Catherine, additional, Galloway, James, additional, Goodman, Anna L., additional, Heer, Amardeep, additional, Higham, Andrew, additional, Iyengar, Shalini, additional, Jamal, Arham, additional, Jeanes, Christopher, additional, Kalra, Philip A., additional, Kyriakidou, Christina, additional, McAuley, Daniel F., additional, Meyrick, Agnieszka, additional, Minassian, Angela M., additional, Minton, Jane, additional, Moore, Patrick, additional, Munsoor, Imrozia, additional, Nicholls, Helen, additional, Osanlou, Orod, additional, Packham, Jonathan, additional, Pretswell, Carol H., additional, Francisco Ramos, Alberto San, additional, Saralaya, Dinesh, additional, Sheridan, Ray P., additional, Smith, Richard, additional, Soiza, Roy L., additional, Swift, Pauline A., additional, Thomson, Emma C., additional, Turner, Jeremy, additional, Viljoen, Marianne Elizabeth, additional, Albert, Gary, additional, Cho, Iksung, additional, Dubovsky, Filip, additional, Glenn, Greg, additional, Rivers, Joy, additional, Robertson, Andreana, additional, Smith, Kathy, additional, and Toback, Seth, additional
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- 2021
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10. Safety, immunogenicity, and efficacy of a COVID-19 vaccine (NVX-CoV2373) co-administered with seasonal influenza vaccines: an exploratory substudy of a randomised, observer-blinded, placebo-controlled, phase 3 trial
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Toback, Seth, Galiza, Eva, Cosgrove, Catherine, Galloway, James, Goodman, Anna L, Swift, Pauline A, Rajaram, Sankarasubramanian, Graves-Jones, Alison, Edelman, Jonathan, Burns, Fiona, Minassian, Angela M, Cho, Iksung, Kumar, Lakshmi, Plested, Joyce S, Rivers, E Joy, Robertson, Andreana, Dubovsky, Filip, Glenn, Greg, Heath, Paul T, Soiza, Roy L., Brittain-Long, Robin, Scicluna, Chiara, Edwards, Carole, Mackay, Lynn, D'Allesandro, Mariella, Nicol, Amy, Norris, Karen, Mann, Sandra, Lawrence, Heather, Valentine, Ruth, Viljoen, Marianne Elizabeth, Pretswell, Carol H., Nicholls, Helen, Munsoor, Imrozia, Meyrick, Agnieszka, Kyriakidou, Christina, Iyengar, Shalini, Jamal, Arham, Richards, Nick, Price, Helen, Rowbotham, Bridie, Bird, Danielle, Smith, Karen, Littler, Olga, Fielding, Kirsty, Townsend-Rose, Anna, Miller, Karen, Davis, Jessica, Elliot-Garwood, Alison, Trottier, Lauren, Edwards, Paul, McFarland, Margaret, Osanlou, Orod, Longshaw, Laura, Stockport, Jane, Grundy, Lynne, Broad, Katharine Lucy, Regan, Karen, Storton, Kim, and Ryan-Wakeling, Declan
- Abstract
Background: Safety and immunogenicity of COVID-19 vaccines when co-administered with influenza vaccines have not yet been reported. Methods: A sub-study on influenza vaccine co-administration was conducted as part of the phase 3 randomised trial of NVX-CoV2373’s safety and efficacy; ~400 participants meeting main study entry criteria, with no contraindications to influenza vaccination, were enroled. After randomisation to receive NVX-CoV2373 or placebo, sub-study participants received an open-label influenza vaccine at the same time as the first dose of NVX-CoV2373. Reactogenicity was evaluated for 7 days post-vaccination plus monitoring for unsolicited adverse events (AEs), medically-attended AEs (MAAEs), and serious AEs (SAEs). Vaccine efficacy against COVID-19 was assessed. Findings: Sub-study participants were younger (median age 39; 6.7 % ≥65 years), more racially diverse, and had fewer comorbid conditions than main study participants. Reactogenicity events more common in co-administration group included tenderness (70.1% vs 57.6%) or pain (39.7% vs 29.3%) at injection site, fatigue (27.7% vs 19.4%), and muscle pain (28.3% vs 21.4%). Rates of unsolicited AEs, MAAEs, and SAEs were low and balanced between the two groups. Co-administration resulted in no change to influenza vaccine immune response, while a reduction in antibody responses to the NVX-CoV2373 vaccine was noted. Vaccine efficacy against COVID-19 was 87.5% (95% CI: -0.2, 98.4) in those 18
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- 2021
11. Accuracy of liver function tests for predicting adverse maternal and fetal outcomes in women with preeclampsia: a systematic review
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Thangaratinam, Shakila, Koopmans, Corine M., Iyengar, Shalini, Zamora, Javier, Ismail, Khaled M.K., Mol, Ben W.J., and Khan, Khalid S.
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- 2011
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12. Selectively Assertive: Interventions of India’s Supreme Court to Enforce Environmental Laws
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Iyengar, Shalini, primary, Dolšak, Nives, additional, and Prakash, Aseem, additional
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- 2019
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13. What’s Past Should be Prologue: India’s Forest Commons and the Rights of Traditional Communities
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Dhar, Preeta, primary and Iyengar, Shalini, additional
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- 2019
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14. A Legal Guide to Immigration Detention in Italy. An English overview of the Italian, European and international legal framework that governs immigration detention in Italy
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Iyengar, Shalini, Landri, Carla, Mini, Margherita, Ogada-Osir, Abigael, Roman, Emanuela, Skalon, Tatiana, Stege, Ulrich, Veglio, Maurizio, and IUC Turin
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International human rights law ,Council of Europe human rights law ,European Union law on immigration detention ,Immigration detention ,Italian law on immigration detention - Abstract
The information contained in this document was produced to introduce university students to Italian and European migration law. Part I.Italian law on immigration detention.Part II.European Union law on immigration detention.Part III: International and Council of Europe human rights law.Glossary.Useful websites and articles on migration and immigration detention in Europe.
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- 2013
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15. Betwixt and Between – A Human Rights Investigation Into Turin's Immigration Detention center
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Iyengar, Shalini, Landri, Carla, Mini, Margherita, Ogada-Osir, Abigael, Roman, Emanuela, Skalon, Tatiana, Stege, Ulrich, Veglio, Maurizio, IUC Turin, Stege, Ulrich, Veglio, Maurizio, Roman, Emanuela, and Ogada-Osir, Abigael
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human rights and migration law ,detained migrants ,immigration detention ,migration research ,Turin centro di identificazione ed espulsione - Abstract
This report investigates the extent to which Italian, European and international human rights and migration law is applied inTurin’scentro di identificazione ed espulsione(Turin’s CIE)- an immigration detention centre in northern Italy. This study was motivated by the fact that a number of institutions and organisations at local, national and international level have expressed concern about the current praxis of administrative detention of irregular migrants in Italy. The inconsistency between the explicit and implicit aims of immigration detention centers is of particular concern because it gives rise to a situation that is a fertile ground for abuse, inefficiencies and shocking human rights violations. In order to evaluate the application ofhuman rights law in Turin’s CIE, the CIE Research Project considers both individual and systemic problems faced by detainees, their families and people who have direct contact with the centre in a professional or voluntary capacity. These problems are analysed in terms of the conditions of detention as well as the judicial and legal processes that surround immigration detention. Throughout the research a concerted attempt was made to give voice to the lived experience of interviewed migrants; an element which is unfortunately all too often missing from research on immigration in Italy.The research was limited to experiences of detention in Turin’s CIE in theperiod January 2011 - June 2012 inclusive. As part of this research project, twenty-nine recorded interviews of between forty and ninety minutes were conducted with current and former immigration detainees and experienced lawyers, NGO workers, religious volunteers and a journalist. The interviews were semi structured and different but comparable interview forms were used with different categories of interviewees. These forms were designed in a manner that aimed to reveal information necessary to evaluate the application of civil and political rights, as well as economic, cultural and social rights. Moreover, in order to try to access a broad cross-section of people with experienceinside Turin’s CIE,researchers were available to conduct interviews fluently with foreign citizens in their choice of seven languages. The report also draws on a range of secondary sources both in terms of background research and methodological modelling. Estratti in italiano– Responses from Authorities
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- 2012
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16. Betwixt and Between: Turin's CIE. Un'indagine sui diritti umani all'interno del centro di identificazione ed espulsione di Torino
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Roman, Emanuela, Veglio, Maurizio, Iyengar, Shalini, Landri, Carla, Mini, Margherita, Ogada-Osir, Abigael, Skalon, Tatiana, Stege, Ulrich, IUC Turin, Stege, Ulrich, Veglio, Maurizio, Roman, Emanuela, and Ogada-Osir, Abigael
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diritti fondamentali ,migranti irregolari ,legislazione sull'immigrazione ,Centro di Identificazione ed Espulsione (CIE) di Torino ,trattenuti in Italia - Abstract
L’obiettivo del presente studio è quello di analizzare in quale misura i diritti fondamentali e la legislazione italiana, europea ed internazionale sull’immigrazione trovino applicazione all’interno del Centro di Identificazione ed Espulsione (CIE) di Torino. Il rapporto nasce in seguito alle gravi preoccupazionimanifestate da istituzioni ed organizzazioni a livello locale, nazionale ed internazionale in merito alle esperienze di detenzione amministrativa dei migranti irregolari in Italia. Le discordanze tra gli scopi espliciti ed impliciti dei centri per il trattenimento degli stranieri possono infatti rappresentare un terreno fertile per abusi, inefficienze e violazioni dei diritti umani. Il progetto di ricerca sul CIE di Torino ha analizzato, in chiave individuale e in una prospettiva di sistema, i problemi affrontati quotidianamente dai trattenuti, dalle loro famiglie e dalle persone che hanno un contatto diretto con il centro, professionisti e volontari. In particolare la ricerca ha tentato di dare voce all’esperienza vissuta dei migranti trattenuti, la cui prospettiva ha raramente trovato riconoscimento e diffusione in Italia. A tal fine, considerato il periodo compreso tra gennaio 2011 e giugno 2012, sono state svolte ventinove interviste – di durata compresa tra i quaranta e i novanta minuti – con trattenuti ed ex trattenuti, nonché con avvocati, membri di ONG, volontari religiosi edun giornalista. Full English version–Responses from Authorities
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- 2012
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17. Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine.
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Heath PT, Galiza EP, Baxter DN, Boffito M, Browne D, Burns F, Chadwick DR, Clark R, Cosgrove C, Galloway J, Goodman AL, Heer A, Higham A, Iyengar S, Jamal A, Jeanes C, Kalra PA, Kyriakidou C, McAuley DF, Meyrick A, Minassian AM, Minton J, Moore P, Munsoor I, Nicholls H, Osanlou O, Packham J, Pretswell CH, San Francisco Ramos A, Saralaya D, Sheridan RP, Smith R, Soiza RL, Swift PA, Thomson EC, Turner J, Viljoen ME, Albert G, Cho I, Dubovsky F, Glenn G, Rivers J, Robertson A, Smith K, and Toback S
- Subjects
- Adolescent, Adult, Aged, Aged, 80 and over, COVID-19 epidemiology, Humans, Injections, Intramuscular adverse effects, Middle Aged, SARS-CoV-2, Single-Blind Method, Vaccines, Synthetic immunology, Young Adult, COVID-19 prevention & control, COVID-19 Vaccines administration & dosage, COVID-19 Vaccines adverse effects, COVID-19 Vaccines immunology, Immunogenicity, Vaccine
- Abstract
Background: Early clinical data from studies of the NVX-CoV2373 vaccine (Novavax), a recombinant nanoparticle vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that contains the full-length spike glycoprotein of the prototype strain plus Matrix-M adjuvant, showed that the vaccine was safe and associated with a robust immune response in healthy adult participants. Additional data were needed regarding the efficacy, immunogenicity, and safety of this vaccine in a larger population., Methods: In this phase 3, randomized, observer-blinded, placebo-controlled trial conducted at 33 sites in the United Kingdom, we assigned adults between the ages of 18 and 84 years in a 1:1 ratio to receive two intramuscular 5-μg doses of NVX-CoV2373 or placebo administered 21 days apart. The primary efficacy end point was virologically confirmed mild, moderate, or severe SARS-CoV-2 infection with an onset at least 7 days after the second injection in participants who were serologically negative at baseline., Results: A total of 15,187 participants underwent randomization, and 14,039 were included in the per-protocol efficacy population. Of the participants, 27.9% were 65 years of age or older, and 44.6% had coexisting illnesses. Infections were reported in 10 participants in the vaccine group and in 96 in the placebo group, with a symptom onset of at least 7 days after the second injection, for a vaccine efficacy of 89.7% (95% confidence interval [CI], 80.2 to 94.6). No hospitalizations or deaths were reported among the 10 cases in the vaccine group. Five cases of severe infection were reported, all of which were in the placebo group. A post hoc analysis showed an efficacy of 86.3% (95% CI, 71.3 to 93.5) against the B.1.1.7 (or alpha) variant and 96.4% (95% CI, 73.8 to 99.5) against non-B.1.1.7 variants. Reactogenicity was generally mild and transient. The incidence of serious adverse events was low and similar in the two groups., Conclusions: A two-dose regimen of the NVX-CoV2373 vaccine administered to adult participants conferred 89.7% protection against SARS-CoV-2 infection and showed high efficacy against the B.1.1.7 variant. (Funded by Novavax; EudraCT number, 2020-004123-16.)., (Copyright © 2021 Massachusetts Medical Society.)
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- 2021
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