Lot-to-lot consistency, safety and immunogenicity of 3 lots of Haemophilus influenzae type b conjugate vaccine: results from a phase III randomized, multicenter study in infants

•The study vaccine (Hib-TT) administered according to a 3+1 schedule is immunogenic.•Immune responses to Hib-TT vaccination and to licensed Hib vaccines are comparable.•Hib-TT primary and booster vaccination safety profiles are similar to other Hib vaccines.•Immune response to routine vaccines is not impacted by co-administration with Hib-TT.