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Evaluating the Effectiveness of a Pneumococcal Immunisation Campaign in a Camp for Internally Displaced People

Study acronym: EEPICC
StatusActive, Not Recruiting
PhasePhase 4
Started
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Record History

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  1. Notable Primary completion date changed from estimate of Dec 2023 to Jan 18, 2025v2 Show 7 more changesShow less
    • Start date changed from estimate of Nov 2021 to Nov 27, 2022
    • Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 1500 to confirmed 2882
    • Study completion date: Dec 2023 to Feb 28, 2026
    • Eligibility criteria shortened, about 142 words
    • Site contact updated
    • Publications: 1 to 2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Pneumococcal conjugate vaccine (PCV) is used routinely worldwide as part of infant immunisations to prevent acquisition of S. pneumoniae, the aetiologic agent responsible for a large proportion of early childhood pneumonia and invasive disease. However, PCV has seen minimal uptake in populations affected by forced displacement and humanitarian crises, where the burden of pneumococcal disease is plausibly elevated. This study seeks to generate evidence on appropriate vaccination strategies for crisis-affected populations. The investigators plan to exhaustively vaccinate children aged between six months and four years in a camp for displaced persons outside Hargeisa, the capital of Somaliland. The study will deliver PCV in a campaign modality, so as to achieve both short- and long-term herd immunity effects that, the investigators hypothesise, will reduce population-wide nasopharyngeal S. pneumoniae transmission and thereby protect young children from pneumococcal disease. The study will adopt a quasi-experimental design, with baseline and post-intervention surveys to evaluate changes in pneumococcal carriage, complemented by safety assessment in children aged over 2 years, who fall outside of the WHO prequalification age range for the vaccine that will be used in this study (i.e. PNEUMOSIL) and for whom PCV safety data are scarce. In addition, we the study will also collect longitudinal data on incidence of pneumonia and antibiotic prescriptions in the camp.
Trial Details
NCT Number NCT04945681
Lead Sponsor London School of Hygiene and Tropical Medicine
Collaborators: Save the Children, Murdoch Childrens Research Institute, Ministry of Health Development, Somaliland
Conditions
(from sponsor)
Pneumococcal Infections
Related terms Pneumococcal Infections
Enrollment 2,882 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov