Mass Campaigns With Fractional Dose Pneumococcal Vaccines in Sub-Saharan Africa (fPCV) (NCT05175014) | Clinical Trial Compass
CompletedPhase 4
Mass Campaigns With Fractional Dose Pneumococcal Vaccines in Sub-Saharan Africa (fPCV)
Niger44,618 participantsStarted 2021-12-30
Plain-language 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.
Who can participate
Age range1 Year – 9 Years
SexALL
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Inclusion criteria
✓. Aged 1-9 years
✓. Residing in the villages included in the study
✓. Parent or caretaker provides informed consent for the child to participate in the study
Exclusion criteria
✕. Head or facial injuries that contraindicate nasopharyngeal swabbing
✕. Any condition or criteria, including acute or chronic clinically significant abnormality that in the opinion of the investigator might compromise the wellbeing of the participant or interfere with the outcome of the study
✕. Aged 1-9 years
✕. Residing in the villages included in the study and allocated to vaccination
✕. Head of the household or main caretaker provides consent for the child to be vaccinated
✕. Hypersensitivity to any component of the vaccine, including diphtheria toxoid
✕
What they're measuring
1
Effect of a Single Dose PCV10 Campaign in the Reduction of VT Carriage
Timeframe: During three months of vaccination campaign, and 6 months post-vaccination campaign