A randomized, open label trial to evaluate and compare the immunogenicity and safety of a novel liquid hexavalent DTwP-Hib/Hep B-IPV (EasySix™) to licensed combination vaccines in healthy infants.

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. CLINICAL TRIAL REGISTRATION: CTRI/2015/02/005578.

A randomized, open-label clinical trial to evaluate immunogenicity and safety of an indigenously developed DTwP-Hib tetravalent combination vaccine (Easyfour®-TT) with Quadrovax® in Indian infants.

An open-label, randomized, multi-center trial was conducted to compare the immunogenicity and safety of an indigenously developed tetravalent DTwP-Hib vaccine, Easyfour®-TT with a commercially available vaccine, Quadrovax®. A total of 244 infants in good health, aged 6-10 weeks, were randomized in a 1:1 allocation to receive three doses of the test or comparator vaccine. Immunogenicity of the vaccines was determined by measuring the baseline and post-vaccination antibody response against the vaccine antigens; safety was evaluated in terms of local and systemic reactions (solicited and unsolicited) reported during the trial. Similar levels of seroprotection/seroresponse were achieved, 4 weeks after receiving 3 doses of Easyfour®-TT and Quadrovax®, and the antibody response of Easyfour®-TT was found non-inferior to Quadrovax®, against all four vaccine antigens. Both vaccines were well tolerated and had similar reactogenicity profiles, with a significantly lower occurrence of local (redness at injection site) and systemic reactions (irritability post-vaccination) with Easyfour®-TT vaccine as compared to Quadrovax® (p < 0.05). All adverse events resolved completely with no sequelae. All through the study, only one serious adverse event was observed that completely resolved upon treatment and was deemed unrelated to the vaccine administered. This study demonstrated that Easyfour®-TT vaccine was safe and immunogenic. CLINICAL TRIAL REGISTRATION NUMBER: CTRI/2014/12/005326 (registered with the Clinical Trial Registry of India (CTRI)).