Abstract
Immunogenicity and safety of a novel ten-valent pneumococcal conjugate vaccine in healthy infants in The Gambia: a phase 3, randomised, double-blind, non-inferiority trial
Highlights
An affordable pneumococcal conjugate vaccine (PCV) is needed to ensure sustainable access in low-income and middle-income countries
As recommended by the WHO Technical Report Series, geometric mean concentrations (GMCs) and seroresponse rates for serotypes 6A and 19A, the non-matched serotypes in SIIPL-PCV, were compared with data for the serotype in PHiD-CV with the lowest seroresponse rate.[12]
The deaths were not considered to be related to the study vaccine or protocol. This phase 3 trial was designed to show that SIIPL-PCV meets the specifications set out in the WHO Technical Report Series for the clinical assessment of PCVs and the target product profile, which defines the criteria that new PCVs must meet to secure purchase for Gavi-supported countries.[11,26]
Summary
An affordable pneumococcal conjugate vaccine (PCV) is needed to ensure sustainable access in low-income and middle-income countries. This trial examined the immunogenicity and safety of a novel ten-valent PCV (SIIPL-PCV) containing serotypes 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F, and 23F compared with the pneumococcal polysaccharide protein D-conjugate vaccine (PHiD-CV; Synflorix; GlaxoSmithKline; Brentford, UK)
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