Results
A total of 460 subjects were enrolled between December 22, 2018, and April 08, 2019, and randomized into 2 groups, group 1 (Investigational DTwP-HepB-Hib vaccine formulation, primary series, n = 232) and group 2 (Comparator (licensed) DTwP-HepB-Hib vaccine formulation, primary series, n = 228). A total of 447 subjects completed the vaccination schedule (3-dose primary series) (225 and 222 subjects in groups 1 and 2 respectively), whereas 439 patients completed the study till D84 (221 and 218 subjects in groups 1 and 2 respectively). Protocol deviations including incomplete vaccination schedule, out of window visits, and randomization errors were reported among 45 subjects (19 and 26 subjects in groups 1 and 2 respectively); (