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

Abstract

CTRI/2014/12/005326 (registered with the Clinical Trial Registry of India (CTRI)).

Lot-to-lot consistency of a hexavalent DTwP-IPV-HB-PRP∼T vaccine and non-inferiority to separate DTwP-HB-PRP∼T and IPV antigen-matching vaccines at 6–8, 10–12, and 14–16 weeks of age co-administered with oral rotavirus vaccine in healthy infants in India: A multi-center, randomized, controlled study

“…The use of the ECL assay for the evaluation of the pertussis response in our study provides data that are precise, accurate, and reproducible [8] . Commercially available assays developed for routine pertussis diagnostic purposes that have been used in the evaluation of pertussis immunogenicity in many other clinical studies of wP-containing vaccines [28] , [29] , [30] , [31] , [32] , [41] , [42] , [43] have unknown specificity and are less well-suited to the robust evaluation that is required in clinical trials. Additionally, the pertussis component of the DTwP-IPV-HB-PRP∼T vaccine is similar to that contained in an established range of vaccines (DTCoq, Tetracoq, Pentacoq) that have been used extensively and have shown efficacy and field effectiveness against pertussis [44] , [45] , [46] .…”

Cost‐minimization analysis of DTaP‐IPV‐Hib combination vaccine in China: A nationwide cross‐sectional study

“…11 World Health Organization (WHO) has promoted the use of combination vaccines for immunization programs in 2017. 12 Countries, notably the US, Canada, and India, have introduced the DTaP-IPV-Hib combination vaccine into the routine childhood immunization program, replacing the separated DTaP, IPV, and Hib vaccines. In China, the DTaP-IPV-Hib combination vaccine has been approved; however, it is not integrated into NIP.…”

“…A systematic evaluation and meta‐analysis also suggested that the DTaP‐IPV‐Hib combination vaccine and separate vaccines did not differ concerning immunogenicity parameters 11 . World Health Organization (WHO) has promoted the use of combination vaccines for immunization programs in 2017 12 . Countries, notably the US, Canada, and India, have introduced the DTaP‐IPV‐Hib combination vaccine into the routine childhood immunization program, replacing the separated DTaP, IPV, and Hib vaccines.…”