Clinical Research Department, Panacea Biotec Ltd., G-3, B-1 Extn/Mohan Co-op, Industrial Estate, Mathura Road, New Delhi, Delhi 110044, India.
Vaccine. 2018 Apr 19;36(17):2378-2384. doi: 10.1016/j.vaccine.2017.09.029. Epub 2018 Mar 23.
Immunogenicity and safety of a newly developed liquid DTwP-Hib/HepB-IPV hexavalent vaccine (EasySix™) was evaluated and compared with administration of commercially licensed Pentavac SD® (DTwP-HepB/Hib) and Imovax Polio® vaccine in an open-label, randomized multi-centric trial. 284 participants, aged 6-10weeks, randomized in a 1:1 allocation, received three doses of test or comparator vaccines, administered 4weeks apart. Immunogenicity of the vaccines was determined by measuring the baseline and post-vaccination antibody responses and comparing the proportions of subjects achieving seroprotection against the vaccine antigens; safety was evaluated in terms of solicited (local and systemic) and unsolicited incidences in the follow up phase. Post-vaccination, seroprotection was achieved against all six vaccine antigens in both vaccine groups. The seroresponse rate as well as geometric mean titers of antibody for all vaccine components were comparable between EasySix™ and Pentavac SD®-Imovax Polio® group. Both vaccines had similar reactogenicity profiles and were well tolerated; all adverse events resolved completely without any sequelae. Only one serious adverse event was reported that completely resolved; it was regarded unconnected to the vaccine administered. This study demonstrated that immunogenicity and safety profiles of EasySix™ vaccine, manufactured by Panacea Biotec Ltd, are non-inferior to the commercially available vaccines.
CTRI/2015/02/005578.
新开发的液体 DTwP-Hib/HepB-IPV 六价疫苗（EasySix™）的免疫原性和安全性进行了评估，并与市售 Pentavac SD®（DTwP-HepB/Hib）和 Imovax Polio®疫苗进行了比较，这是一项开放性、随机、多中心试验。284 名年龄在 6-10 周的参与者以 1:1 的比例随机分配，接受三剂试验或对照疫苗，间隔 4 周。通过测量基线和接种后抗体反应，并比较达到疫苗抗原血清保护的受试者比例来确定疫苗的免疫原性；在随访阶段，从征状（局部和全身）和不征状两个方面评估安全性。接种后，两组疫苗均能针对所有六种疫苗抗原达到血清保护。EasySix™和 Pentavac SD®-Imovax Polio®组之间，疫苗的血清反应率和抗体几何平均滴度（GMT）均相当。两种疫苗的反应原性相似，均具有良好的耐受性；所有不良事件均完全消退，无任何后遗症。仅报告了 1 例严重不良事件，完全消退；被认为与接种的疫苗无关。这项研究表明，由 Panacea Biotec Ltd 生产的 EasySix™疫苗具有与市售疫苗相当的免疫原性和安全性。
CTRI/2015/02/005578。
