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A Phase III open-label, randomized, active controlled clinical study to assess safety, immunogenicity and lot-to-lot consistency of a bovine-human reassortant pentavalent rotavirus vaccine in Indian infants.
Rathi N, Desai S, Kawade A, Venkatramanan P, Kundu R, Lalwani SK, Dubey AP, Venkateswara Rao J, Narayanappa D, Ghildiyal R, Gogtay N, Venugopal P, Palkar S, Munshi R, Kang G, Babji S, Bavdekar A, Juvekar S, Ganguly N, Niyogi P, Ghosh Uttam K, Rajani HS, Kondekar A, Kumbhar D, Mohanlal S, Agarwal MC, Shetty P, Antony K, Gunale B, Dharmadhikari A, Tang Y, Kulkarni PS, Flores J. Rathi N, et al. Among authors: gunale b. Vaccine. 2018 Dec 18;36(52):7943-7949. doi: 10.1016/j.vaccine.2018.11.006. Epub 2018 Nov 9. Vaccine. 2018. PMID: 30420116 Free PMC article. Clinical Trial.
Safety and immunogenicity of dry powder measles vaccine administered by inhalation: a randomized controlled Phase I clinical trial.
MVDP author group; Cape S, Chaudhari A, Vaidya V, Mulay R, Agarkhedkar S, Shermer C, Collins M, Anderson R, Agarkhedkar S, Kulkarni PS, Winston S, Sievers R, Dhere RM, Gunale B, Powell K, Rota PA, Papania M. MVDP author group, et al. Among authors: gunale b. Vaccine. 2014 Nov 28;32(50):6791-7. doi: 10.1016/j.vaccine.2014.09.071. Epub 2014 Oct 22. Vaccine. 2014. PMID: 25446830 Clinical Trial.
A randomized non-inferiority clinical study to assess post-exposure prophylaxis by a new purified vero cell rabies vaccine (Rabivax-S) administered by intramuscular and intradermal routes.
Bose A, Munshi R, Tripathy RM, Madhusudana SN, Harish BR, Thaker S, Mahendra BJ, Gunale B, Gogtay NJ, Thatte UM, Mani RS, Manjunath K, George K, Yajaman AB, Sahai A, Dhere RM, Alex RG, Adhikari DD, Abhilash, Raghava V, Kumbhar D, Behera TR, Kulkarni PS. Bose A, et al. Among authors: gunale b. Vaccine. 2016 Sep 14;34(40):4820-6. doi: 10.1016/j.vaccine.2016.08.005. Epub 2016 Aug 21. Vaccine. 2016. PMID: 27554534 Clinical Trial.
Comparison of a Novel Human Rabies Monoclonal Antibody to Human Rabies Immunoglobulin for Postexposure Prophylaxis: A Phase 2/3, Randomized, Single-Blind, Noninferiority, Controlled Study.
Gogtay NJ, Munshi R, Ashwath Narayana DH, Mahendra BJ, Kshirsagar V, Gunale B, Moore S, Cheslock P, Thaker S, Deshpande S, Karande S, Kumbhar D, Ravish HS, Harish BR, Pisal SS, Dhere R, Parulekar V, Blackwelder WC, Molrine DC, Kulkarni PS. Gogtay NJ, et al. Among authors: gunale b. Clin Infect Dis. 2018 Jan 18;66(3):387-395. doi: 10.1093/cid/cix791. Clin Infect Dis. 2018. PMID: 29020321 Clinical Trial.
Immunogenicity and safety of measles-mumps-rubella vaccine delivered by disposable-syringe jet injector in India: A randomized, parallel group, non-inferiority trial.
Bavdekar A, Oswal J, Ramanan PV, Aundhkar C, Venugopal P, Kapse D, Miller T, McGray S, Zehrung D, Kulkarni PS; SII MMR author group. Bavdekar A, et al. Vaccine. 2018 Feb 21;36(9):1220-1226. doi: 10.1016/j.vaccine.2018.01.006. Epub 2018 Feb 1. Vaccine. 2018. PMID: 29395526 Free PMC article. Clinical Trial.
Non-interference of Bovine-Human reassortant pentavalent rotavirus vaccine ROTASIIL® with the immunogenicity of infant vaccines in comparison with a licensed rotavirus vaccine.
Desai S, Rathi N, Kawade A, Venkatramanan P, Kundu R, Lalwani SK, Dubey AP, Venkateswara Rao J, Narayanappa D, Ghildiyal R, Gogtay NJ, Venugopal P, Palkar S, Munshi R, Bavdekar A, Juvekar S, Ganguly N, Niyogi P, Uttam KG, Kondekar A, Kumbhar D, Mohanlal S, Agarwal MC, Shetty P, Antony K, Gunale B, Dharmadhikari A, Deshpande J, Nalavade U, Sharma D, Bansal A, Tang Y, Flores J, Kulkarni PS. Desai S, et al. Among authors: gunale b. Vaccine. 2018 Sep 5;36(37):5519-5523. doi: 10.1016/j.vaccine.2018.07.064. Epub 2018 Aug 10. Vaccine. 2018. PMID: 30104114 Free PMC article. Clinical Trial.
Clinical study of safety and immunogenicity of pentavalent DTP-HB-Hib vaccine administered by disposable-syringe jet injector in India.
Bavdekar A, Malshe N, Ravichandran L, Sapru A, Kawade A, Lalwani S, Palkar S, Hanumante N, Gunale B, Kapse D, Chaudhari A, Miller T, Saganic L, Jarrahian C, McGray S, Zehrung D, Kulkarni PS. Bavdekar A, et al. Among authors: gunale b. Contemp Clin Trials Commun. 2019 Jan 9;14:100321. doi: 10.1016/j.conctc.2019.100321. eCollection 2019 Jun. Contemp Clin Trials Commun. 2019. PMID: 30899835 Free PMC article.
26 results