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

NCT04945681 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2882

Last updated 2025-06-04

No results posted yet for this study

Summary

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.

Conditions

  • Pneumococcal Infections

Interventions

BIOLOGICAL

Pneumococcal conjugate vaccine

Mass campaign offering simultaneous pneumococcal conjugate vaccination to all children aged below 5 years of age living in Digaale camp, Somaliland. Children aged below 12 months receive 2 doses of vaccine, spaced 4 weeks apart. All other children receive one dose.

Sponsors & Collaborators

  • Save the Children

    collaborator OTHER

  • Murdoch Childrens Research Institute

    collaborator OTHER

  • Ministry of Health Development, Somaliland

    collaborator UNKNOWN

  • London School of Hygiene and Tropical Medicine

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Weeks
Max Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-27
Primary Completion
2025-01-18
Completion
2026-02-28

Countries

  • Somalia

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 NCT04945681 on ClinicalTrials.gov