Potential clinical efficacy of the 10-valent pneumococcal-Protein D conjugate vaccine in children with chronic suppurative lung diseases: A double-blind randomised controlled trial
Background • Chronic suppurative lung diseases (CSLD) in children are important causes of morbidity and recurrent acute exacerbations are associated with long term lung function decline. • Non-‐typeable H. influenzae (NTHi) and S. pneumoniae are commonly isolated from the lower airways of both children and adults with CSLD. • The potential clinical impact of a non-‐typeable Haemophilus influenzae (NTHi) vaccine in children with CSLD has not been investigated. • We aimed to determine the clinical efficacy of the 10-‐valent pneumococcal-‐Protein D conjugate vaccine (10vPHiD-‐CV) in children aged 18-‐months to <18-‐years with CSLD (Immunogenicity data are presented in Poster xxx). Primary clinical objective. • Determine the efficacy of 10vPHiD-‐CV in reducing the incidence of acute exacerbations in the 12-‐months following the 2nd dose of study vaccine. Secondary clinical objectives. • Determine the efficacy of 10vPHiD-‐CV in reducing the incidence of any parent/carer-‐reported respiratory symptoms in the 12 months following the second dose of study vaccine. • Determine the efficacy of 10vPHiD-‐CV in reducing antibiotic use in the 12 months following the second dose of study vaccine