We specified no a-priori null hypothesis for the immunogenicity or safety objectives and all analyses were descriptive. Analyses were by modified intention-to-treat. These studies are registered with, numbers NCT01229176 and NCT01437267.įindings: 320 participants were enrolled and vaccinated in the two trials: 200 in study A (all age groups) and 120 in study B (children and infants only), of whom 317 (99%) were included in the modified intention-to-treat analysis. One dose of Vi-CRM 197 significantly increased concentrations of anti-Vi antibody in adults (from 113 U/mL to 208 U/mL ), children (201 U/mL to 368 U/mL ), and older infants (179 U/mL to 249 U/mL ). However, in children and older infants, a second dose of conjugate vaccine had no incremental effect on antibody titres and, at all ages, concentrations of antibodies increased substantially 6 months after vaccination (from 55 U/mL to 63 U/mL in adults, from 23 U/mL to 51 U/mL in children, and from 21 U/mL to 22 U/mL in older infants). Immune response in infants aged 6–8 weeks was lower than that in older participants and, 6 months after third vaccination, antibody concentrations were significantly higher than pre-vaccination concentrations in Filipino (21 U/mL vs 2♸8 U/mL ), but not Pakistani (3♷6 U/mL vs 2♷7 U/mL ), infants. Vi-CRM 197 was safe and well tolerated and did not induce any significant interference with EPI vaccines. No deaths or vaccine-related serious adverse events were reported throughout the studies. Interpretation: Vi-CRM 197 is safe and immunogenic in endemic populations of all ages.
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