Clinical Trial Info

Phase 3 Study of 10-valent Pneumococcal Conjugate Vaccine (PNEUMOSIL) Administered in a 2+1 Schedule to Healthy Infants

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The current Phase 3 descriptive study will provide data necessary to evaluate the safety and immunogenicity of PNEUMOSIL when administered in an alternative schedule to the 3 dose primary schedule (3+0) evaluated in the Phase 3 pivotal trial (VAC-056) - namely in a 2 dose primary and booster (2+1) schedule - and compare immunogenicity to that of both currently licensed second-generation PCVs administered in the same 2+1 schedule.

This prospective, single-center, randomized, active-controlled, observer-blind, Phase 3 descriptive study, 660 healthy Gambian pneumococcal conjugate vaccine (PCV)-naïve infants will be randomized 1:1:1 to receive 3 doses of either PNEUMOSIL, Synflorix or Prevenar 13 at 6 weeks, 14 weeks and 9 months of age. Standard EPI vaccinations in The Gambia, will be given concomitantly with all 3 doses of study vaccine.Blood will be collected 4 weeks post second dose, pre-booster and 4 weeks post booster dose for immunogenicity assessments.