At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Determining Whether Mass Campaigns With Fractional Dose PCV10 Would Accelerate Herd Protection Against Pneumococcal Transmission in Sub-Saharan Africa
In Brief
A Phase 4 clinical trial evaluating PCV10 full dose and PCV10 fractional dose for Pneumococcal Carriage. Completed, enrolled 44,618 participants across 1 site.
Detailed Summary
The aim of this study is to assess the impact of a mass campaign with a single, fractional dose of Pneumosil®, a PCV10, on VT carriage. A 20% fractional dose (1/5th) will be used as a practical formulation to prepare and administer. This study will assess whether the impact of a single fractional dose mass campaign on carriage is non-inferior to a single full dose mass campaign in a cluster randomized trial in a low coverage setting in Niger. The results would provide evidence of the population-level direct and indirect impact of fractional dose in older children which will be completed by mathematical modelling, to inform the policy debate regarding PCV dosing schedules in different contexts. This trial and the modelling exercises that follow, would allow for larger scale evaluation of fractional dose PCV strategies in multiple contexts.
Study Details
Timeline
Interventions
Mass vaccination campaign with one single dose PCV10 vaccine administered as a full dose.
Mass vaccination campaign with one single dose PCV10 vaccine administered as a fractional dose.