Interpretation: Vi-CRM 197 is safe and immunogenic in endemic populations of all ages. No deaths or vaccine-related serious adverse events were reported throughout the studies. Vi-CRM 197 was safe and well tolerated and did not induce any significant interference with EPI vaccines. ![]() 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. ![]() 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). 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 ). 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. Analyses were by modified intention-to-treat. We specified no a-priori null hypothesis for the immunogenicity or safety objectives and all analyses were descriptive. With the exception of designated study site personnel responsible for vaccine preparation, study investigators, those assessing outcomes, and data analysts were masked to treatment allocation. ![]() Both infant populations received Vi-CRM 197 concomitantly with vaccines of the Expanded Programme on Immunization (EPI), according to WHO schedule. ![]() Adults aged 18–45 years, children aged 24–59 months, older infants aged 9–12 months, and infants aged 6–8 weeks were randomly assigned (1:1) with a computer-generated randomisation list (block size of four) to receive either 5 μg Vi-CRM 197 or 25 μg Vi-polysaccharide vaccine (or 13-valent pneumococcal conjugate vaccine in children younger than 2 years). Methods : We did two randomised, observer-blind, age de-escalation, phase 2 trials at two sites in Pakistan and India (study A), and at one site in the Philippines (study B), between March 2, 2011, and Aug 9, 2012. We aimed to assess the immunogenicity and safety of Vi-CRM 197 in participants of various ages in endemic countries in south and southeast Asia. Because present vaccines are not recommended for children younger than 2 years, the Novartis Vaccines Institute for Global Health developed a conjugate vaccine (Vi-CRM 197) for infant immunisation. Zulfiqar A Bhutta, Maria Rosario Capeding, Ashish Bavdekar, Elisa Marchetti, Shabina Ariff, Sajid B Soofi, Alessandra Anemona, Muhammad A Habib, Edison Alberto, Sanjay Juvekar, Rana M Qasim Khan, Rachid Marhaba, Noshad Ali, Nelia Malubay, Anand Kawade, Allan Saul, Laura B Martin, Audino Podda Abstractīackground : Typhoid vaccination is a public health priority in developing countries where young children are greatly affected by typhoid fever.
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