A first-in-human, multicenter, randomized, active-controlled, observer-blind Phase 1/2 age de-escalation study of IVT PCV 25 designed to evaluate the safety, tolerability, and immunogenicity of the vaccine. Adult subjects will be randomized 1:1 to receive either IVT PCV-25 or Prevnar 20™, and the young children subjects will be randomized 1:1 to receive either IVT PCV-25 or Prevnar 13®. The infant subjects will receive a series of four vaccinations with IVT-PCV-25 at 2, 4, 6 and 12 months of age co-administered with all routine vaccines except for Prevnar 13. The three age-group cohorts will be conducted sequentially to allow for safety and tolerability assessment of IVT PCV 25 in adults prior to age de-escalation to children, and for assessment of immunogenicity in adults, and safety and tolerability in children, prior to age de-escalation to infants.
A first-in-human, Phase 1/2 age de-escalation trial to evaluate safety, tolerability, and immunogenicity of Inventprise's (IVT) 25-valent pneumococcal conjugate vaccine (IVT PCV-25)