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Mass Campaigns With Fractional Dose Pneumococcal Vaccines in Sub-Saharan Africa (fPCV)

NCT05175014 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 44618

Last updated 2024-12-05

Study results available
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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.

Conditions

  • Pneumococcal Carriage

Interventions

BIOLOGICAL

PCV10 full dose

Mass vaccination campaign with one single dose PCV10 vaccine administered as a full dose.

BIOLOGICAL

PCV10 fractional dose

Mass vaccination campaign with one single dose PCV10 vaccine administered as a fractional dose.

Sponsors & Collaborators

  • London School of Hygiene and Tropical Medicine

    collaborator OTHER

  • Kenya Medical Research Institute

    collaborator OTHER

  • Universite Abdou Moumouni de Niamey, Niger

    collaborator OTHER

  • Epicentre

    lead OTHER

Principal Investigators

  • Dr. Rebecca Grais · Epicentre Research Department Director

  • Dr. Matthew Coldiron · Epicentre Research Department Investigator

  • Dr. Issaka Soumana · Epicentre Niger Research Center Assistant Manager

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
9 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-30
Primary Completion
2023-03-14
Completion
2023-10-03

Countries

  • Niger

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05175014 on ClinicalTrials.gov