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Efficacy of a bivalent (D614 + B.1.351) SARS-CoV-2 recombinant protein vaccine with AS03 adjuvant in adults: a phase 3, parallel, randomised, modified double-blind, placebo-controlled trial.
Dayan GH, Rouphael N, Walsh SR, Chen A, Grunenberg N, Allen M, Antony J, Asante KP, Bhate AS, Beresnev T, Bonaparte MI, Celle M, Ceregido MA, Corey L, Dobrianskyi D, Fu B, Grillet MH, Keshtkar-Jahromi M, Juraska M, Kee JJ, Kibuuka H, Koutsoukos M, Masotti R, Michael NL, Neuzil KM, Reynales H, Robb ML, Villagómez Martínez SM, Sawe F, Schuerman L, Tong T, Treanor J, Wartel TA, Diazgranados CA, Chicz RM, Gurunathan S, Savarino S, Sridhar S; VAT00008 Study Team. Dayan GH, et al. Among authors: wartel ta. Lancet Respir Med. 2023 Nov;11(11):975-990. doi: 10.1016/S2213-2600(23)00263-1. Epub 2023 Sep 13. Lancet Respir Med. 2023. PMID: 37716365 Clinical Trial.
Clinical efficacy and safety of a novel tetravalent dengue vaccine in healthy children in Asia: a phase 3, randomised, observer-masked, placebo-controlled trial.
Capeding MR, Tran NH, Hadinegoro SR, Ismail HI, Chotpitayasunondh T, Chua MN, Luong CQ, Rusmil K, Wirawan DN, Nallusamy R, Pitisuttithum P, Thisyakorn U, Yoon IK, van der Vliet D, Langevin E, Laot T, Hutagalung Y, Frago C, Boaz M, Wartel TA, Tornieporth NG, Saville M, Bouckenooghe A; CYD14 Study Group. Capeding MR, et al. Among authors: wartel ta. Lancet. 2014 Oct 11;384(9951):1358-65. doi: 10.1016/S0140-6736(14)61060-6. Epub 2014 Jul 10. Lancet. 2014. PMID: 25018116 Clinical Trial.
Efficacy and Long-Term Safety of a Dengue Vaccine in Regions of Endemic Disease.
Hadinegoro SR, Arredondo-García JL, Capeding MR, Deseda C, Chotpitayasunondh T, Dietze R, Muhammad Ismail HI, Reynales H, Limkittikul K, Rivera-Medina DM, Tran HN, Bouckenooghe A, Chansinghakul D, Cortés M, Fanouillere K, Forrat R, Frago C, Gailhardou S, Jackson N, Noriega F, Plennevaux E, Wartel TA, Zambrano B, Saville M; CYD-TDV Dengue Vaccine Working Group. Hadinegoro SR, et al. Among authors: wartel ta. N Engl J Med. 2015 Sep 24;373(13):1195-206. doi: 10.1056/NEJMoa1506223. Epub 2015 Jul 27. N Engl J Med. 2015. PMID: 26214039 Free article. Clinical Trial.
Symptomatic Dengue Disease in Five Southeast Asian Countries: Epidemiological Evidence from a Dengue Vaccine Trial.
Nealon J, Taurel AF, Capeding MR, Tran NH, Hadinegoro SR, Chotpitayasunondh T, Chong CK, Wartel TA, Beucher S, Frago C, Moureau A, Simmerman M, Laot T, L'Azou M, Bouckenooghe A. Nealon J, et al. Among authors: wartel ta. PLoS Negl Trop Dis. 2016 Aug 17;10(8):e0004918. doi: 10.1371/journal.pntd.0004918. eCollection 2016 Aug. PLoS Negl Trop Dis. 2016. PMID: 27532617 Free PMC article. Clinical Trial.
Four-year safety follow-up of the tetravalent dengue vaccine efficacy randomized controlled trials in Asia and Latin America.
Arredondo-García JL, Hadinegoro SR, Reynales H, Chua MN, Rivera Medina DM, Chotpitayasunondh T, Tran NH, Deseda CC, Wirawan DN, Cortés Supelano M, Frago C, Langevin E, Coronel D, Laot T, Perroud AP, Sanchez L, Bonaparte M, Limkittikul K, Chansinghakul D, Gailhardou S, Noriega F, Wartel TA, Bouckenooghe A, Zambrano B; CYD-TDV Dengue Vaccine Study Group. Arredondo-García JL, et al. Among authors: wartel ta. Clin Microbiol Infect. 2018 Jul;24(7):755-763. doi: 10.1016/j.cmi.2018.01.018. Epub 2018 Feb 8. Clin Microbiol Infect. 2018. PMID: 29408333 Free article.
Challenges and opportunities in setting up a phase III vaccine clinical trial in resource limited settings: Experience from Nepal.
Saluja T, Giri BR, Chaudhary S, Tamrakar D, Kanodia P, Palkar S, Vemula S, Chinaworapong S, Kim B, Gupta BP, Kyoung Jo S, Aspinall S, Rai GK, Steele D, Kim JH, Wartel TA, Sahastrabuddhe S. Saluja T, et al. Among authors: wartel ta. Hum Vaccin Immunother. 2021 Jul 3;17(7):2149-2157. doi: 10.1080/21645515.2020.1855955. Epub 2021 Feb 1. Hum Vaccin Immunother. 2021. PMID: 33524278 Free PMC article.
Safety and immunogenicity of the Vi-DT typhoid conjugate vaccine in healthy volunteers in Nepal: an observer-blind, active-controlled, randomised, non-inferiority, phase 3 trial.
Kumar Rai G, Saluja T, Chaudhary S, Tamrakar D, Kanodia P, Giri BR, Shrestha R, Uranw S, Kim DR, Yang JS, Park IY, Kyung SE, Vemula S, Reddy E J, Kim B, Gupta BP, Jo SK, Ryu JH, Park HK, Shin JH, Lee Y, Kim H, Kim JH, Mojares ZR, Wartel TA, Sahastrabuddhe S. Kumar Rai G, et al. Among authors: wartel ta. Lancet Infect Dis. 2022 Apr;22(4):529-540. doi: 10.1016/S1473-3099(21)00455-2. Epub 2021 Dec 20. Lancet Infect Dis. 2022. PMID: 34942090 Free PMC article. Clinical Trial.
Efficacy of a monovalent (D614) SARS-CoV-2 recombinant protein vaccine with AS03 adjuvant in adults: a phase 3, multi-country study.
Dayan GH, Rouphael N, Walsh SR, Chen A, Grunenberg N, Allen M, Antony J, Bhate AS, Beresnev T, Bonaparte MI, Celle M, Ceregido MA, Corey L, Fu B, Grillet MH, Keshtkar-Jahromi M, Juraska M, Kee JJ, Kaali S, Koutsoukos M, Masotti R, Michael NL, Neuzil KM, Reynales H, Robb ML, Uchiyama A, Sawe F, Schuerman L, Shrestha R, Tong T, Treanor J, Diazgranados CA, Chicz RM, Gurunathan S, Savarino S, Sridhar S; VAT00008 study team. Dayan GH, et al. EClinicalMedicine. 2023 Sep 12;64:102168. doi: 10.1016/j.eclinm.2023.102168. eCollection 2023 Oct. EClinicalMedicine. 2023. PMID: 37936652 Free PMC article.
36 results