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

NCT ID: NCT04945681

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 2882 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-27
• Study Completion Date: 2026-02-28

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Mass vaccination

Mass vaccination of children aged 6 weeks to 4 years old with pneumococcal conjugate vaccine (PNEUMOSIL). Children 6 weeks to 11 months old receive two doses, spaced 4 weeks apart. All other children receive a single dose. Vaccination is simultaneous, as per a campaign delivery strategy.

Group Type: EXPERIMENTAL

Pneumococcal conjugate vaccine

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Resident in Digaale camp

2. Voluntary written/thumb-printed informed consent has been provided by a parent or caregiver

3. Subject's parent/caregiver must be able to comprehend and comply with study requirements and procedures

4. Subject's parents/caregivers must have a readily identifiable place of residence in the study area

Exclusion Criteria

1. Known hypersensitivity to any component of any of the EPI vaccines, including diphtheria toxoid, in the child or any sibling

2. History of allergic disease or history of a serious reaction to any prior vaccination in the child or any sibling

3. History of anaphylactic shock, regardless of cause

4. History of long-term treatment (defined as 14 or more consecutive days) with immunosuppressants or other immune modifying drugs, including glucocorticoids, but excluding topical and inhaled glucocorticoids

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Save the Children

OTHER

Sponsor Role: collaborator

Murdoch Childrens Research Institute

OTHER

Sponsor Role: collaborator

Ministry of Health Development, Somaliland

UNKNOWN

Sponsor Role: collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Digaale internally displaced persons camp

Hargeisa, Hargeisa, Somaliland, Somalia

Countries

Somalia

References

van Zandvoort K, Hassan AI, Bobe MO, Pell CL, Ahmed MS, Ortika BD, Ibrahim S, Abdi MI, Karim MA, Eggo RM, Ali SY, Hinds J, Soleman SM, Cummings R, McGowan CR, Mulholland EK, Hergeye MA, Satzke C, Checchi F, Flasche S. Pre-vaccination carriage prevalence of Streptococcus pneumoniae serotypes among internally displaced people in Somaliland: a cross-sectional study. Pneumonia (Nathan). 2024 Dec 5;16(1):25. doi: 10.1186/s41479-024-00148-6.

Reference Type: BACKGROUND

PMID: 39633426 (View on PubMed)

Other Identifiers

OPP1211787

Identifier Type: -

Identifier Source: org_study_id