Safety and immunogenicity of Biological E's typhoid conjugate vaccine TYPHIBEVⓇ concomitantly administered with measles rubella vaccine: a phase IV prospective, multicenter study

• Typhoid conjugate vaccines induce long-lasting T-cell responses, superior to Vi polysaccharide vaccines. • TYPHIBEV is World Health Organization–prequalified after phase I-III trials and now in routine use. • No safety signals when TYPHIBEV is co-administered with measles rubella in this phase IV trial. • TYPHIBEV and measles component of measles rubella vaccine show no immunogenic interference. • No safety signals with data in 1000+ participants aged 6 months to 45 years. Typhoid infections remain one of the major health concerns worldwide. Vaccines that prevent typhoid, particularly, the conjugated polysaccharide ones, are an important tool in addressing this major health concern. Here, we report on the safety profile of Biological E's TYPHIBEV Ⓡ when administered to infants, children, and young adults and immunogenic non-interference data of TYPHIBEV when co-administered with the measles rubella (MR) vaccine to infants. This phase IV multicenter, open-label study enrolled 1252 healthy subjects aged 6 months to 45 years, stratified into three age subsets. In the 6 months to 2 years age group, 400 subjects aged 9-12 months were randomly allocated 1:1 to receive TYPHIBEV Ⓡ and MR vaccine or MR vaccine only. Blood samples were collected at baseline, day 28 (anti-measles immunoglobulin G by enzyme-linked immunosorbent assay), and day 42 (anti-Vi immunoglobulin G by enzyme-linked immunosorbent assay). Solicited adverse events (AEs) were monitored for 7 days after vaccination, whereas unsolicited events, serious AEs, and medically attended events were recorded throughout. TYPHIBEV Ⓡ was well-tolerated, with injection site pain (5.5%), pyrexia (2.5%), and swelling (2%) being the most frequent AEs. One serious AE of pyrexia was unrelated to the vaccine. Seroprotection rates for Vi and measles antigens were comparable between groups. No safety signals were identified during this study and no immunogenic inference was seen when TYPHIBEV was co-administered with MR. CTRI/2022/02/040285