Safety and immunogenicity of diphtheria-tetanus-pertussis vaccine and hepatitis B vaccine as a new tetravalent combination (DTwP/HB) administered alone and at separate sites (DTwP & HB) including comparison with standard commercially available combination vaccine in Indian infants 6-14 weeks of age

Efficacy of antigen dosage on the hepatitis B vaccine response in infants born to hepatitis B-uninfected and hepatitis B-infected mothers

“…Except for mild pain at the injection site, there were no clinically meaningful injection-site ARs or systemic ARs at either vaccine dosage. This finding was consistent with those of previous safety studies of HB vaccines [14][15][16][17]. The results of our study indicated that the recombinant HB vaccine could be administered safely to neonates and infants and was well tolerated at either dosage.…”

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] .…”

Immunogenicity and safety of an indigenously manufactured reconstituted pentavalent (DTwP-HBV+Hib) vaccine in comparison with a foreign competitor following primary and booster immunization in Indian children

“…11,12 In the current study, we reconstituted both these vaccines and compared this formulation with another similar formulation of a foreign manufacturer's, established vaccine. The results of our study demonstrate that the antibody response of both vaccines were excellent and there was no immunological …”