Pneumococcal InfectionsPhase 4EEPICCNCT04945681
Evaluating the Effectiveness of a Pneumococcal Immunisation Campaign in a Camp for Internally Displaced People
A Phase 4 study testing Pneumococcal conjugate vaccine in people with Pneumococcal Infections, run by London School of Hygiene and Tropical Medicine at 1 site in Somalia.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 weeks to 4 years
- Conditions the study is for
- Pneumococcal Infections
- What is being tested?
- Pneumococcal conjugate vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,882 participants
- Where
- 1 siteSomalia
- Study dates
- 27 Nov 2022to 28 Feb 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 weeks to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Resident in Digaale camp
- Voluntary written/thumb-printed informed consent has been provided by a parent or caregiver
- Subject's parent/caregiver must be able to comprehend and comply with study requirements and procedures
- Subject's parents/caregivers must have a readily identifiable place of residence in the study area
Who cannot join
- Known hypersensitivity to any component of any of the EPI vaccines, including diphtheria toxoid, in the child or any sibling
- History of allergic disease or history of a serious reaction to any prior vaccination in the child or any sibling
- History of anaphylactic shock, regardless of cause
- 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
Trial locations and contacts
1 site in 1 country.
Somalia1 site
Digaale internally displaced persons camp
Hargeisa, Hargeisa, Somaliland
About this study
Official title: Evaluating the Effectiveness of a Pneumococcal Immunisation Campaign in a Camp for Internally Displaced People: A Non-randomised, Quasi-experimental Phase IV Intervention Study
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
- Being tested
- Pneumococcal conjugate vaccine
- Keywords
- Pneumococcal conjugate vaccine, Humanitarian, Crisis, Forced displacement, Mass vaccination, Quasi-experimental
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pneumococcal conjugate vaccineBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Mass vaccination | Experimental | 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. Receives: Biological: Pneumococcal conjugate vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasopharyngeal carriage of one or more colonies of vaccine-type Streptococcus pneumoniae serotypes in children below 24 months old
The outcome is determined at the individual level, through polymerase chain reaction (PCR) microarray analysis of nasal swab samples collected during a cross-sectional, population-representative sample survey of camp residents. The analysis will be stratified by age group (0-11 months, 12-23 months). Vaccine-type serotypes are defined as those that the Pneumosil vaccine (Serum Institute, India) is designed to provide immunity for, and include serotypes serotypes 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F and 23F.
Measured: 6 months, relative to baseline (pre-vaccination)
Nasopharyngeal carriage of one or more colonies of vaccine-type Streptococcus pneumoniae serotypes in children below 24 months old
The outcome is determined at the individual level, through PCR microarray analysis of nasal swab samples collected during a cross-sectional, population-representative sample survey of camp residents. The analysis will be stratified by age group (0-11 months, 12-23 months). Vaccine-type serotypes are defined as those that the Pneumosil vaccine (Serum Institute, India) is designed to provide immunity for, and include serotypes serotypes 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F and 23F.
Measured: 12 months, relative to baseline (pre-vaccination)
Nasopharyngeal carriage of one or more colonies of vaccine-type Streptococcus pneumoniae serotypes in children below 24 months old
The outcome is determined at the individual level, through PCR microarray analysis of nasal swab samples collected during a cross-sectional, population-representative sample survey of camp residents. The analysis will be stratified by age group (0-11 months, 12-23 months). Vaccine-type serotypes are defined as those that the Pneumosil vaccine (Serum Institute, India) is designed to provide immunity for, and include serotypes serotypes 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F and 23F.
Measured: 24 months, relative to baseline (pre-vaccination)
Number and proportion of vaccination recipients who experience solicited local and systemic adverse events following immunisation (AEFI)
The outcome is determined at the individual level. 'Solicited' indicates that adverse events are identified by study staff using a pre-defined checklist of signs and symptoms and proactive monitoring or follow-up of vaccine recipients. AEFI will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) (version 24.0 or later). Outcome ascertainment will occur through (i) in-person monitoring of vaccine recipients for 30 minutes after vaccine administration, and (ii) exhaustive follow-up of all vaccine recipients 7 days after vaccination, with administration of a structured questionnaire to their parents or caregivers. All AEFI will be graded using a severity scale (0 - none; 1 - mild; 2 - moderate; 3- severe; 4 - very severe; 5 - fatal), and analysis will be stratified by severity and age group (6 weeks to 11 months old, 12 to 23 months old, 24 to 59 months old).
Measured: within 7 days of receipt of each vaccine dose
Number and proportion of vaccination recipients who experience solicited or unsolicited severe adverse events (SAE) following vaccination
The outcome is determined at the individual level. SAE are defined as any AEFI with severity >= 3. Outcome ascertainment will occur through (i) in-person monitoring of vaccine recipients for 30 min after vaccine administration, (ii) exhaustive follow-up of all vaccine recipients 7 days after vaccination, with administration of a structured questionnaire to their parents or caregivers; (iii) availability of a 24/7 phone number which caregivers of vaccine recipients will be encouraged to contact; (iv) visits to the camp's single primary healthcare facility, during each day on which vaccination takes place, to identify any children presenting for care with a SAE; and (v) availability of a 24/7 phone number which clinicians at the primary healthcare facility will be encouraged to contact. Each SAE will be followed up until resolution. Relatedness of each SAE to vaccine receipt will be classified as 'unrelated', 'unlikely', 'possible', 'probable', 'definite' and 'not assessable'.
Measured: within 7 days of receipt of each vaccine dose
Secondary outcomes (12)
Nasopharyngeal carriage of one or more colonies of vaccine-type Streptococcus pneumoniae serotypes in children and adults 24 months old or older
The outcome is determined at the individual level, through PCR microarray analysis of nasal swab samples collected during a cross-sectional, population-representative sample survey of camp residents. The analysis will be stratified by age group (24-59 months, 5 to 14 years, 15 to 29 years, 30 to 49 years, 50 years and above). Vaccine-type serotypes are defined as those that the Pneumosil vaccine (Serum Institute, India) is designed to provide immunity for, and include serotypes serotypes 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F and 23F.
Measured: 6 months, relative to baseline (pre-vaccination)
Nasopharyngeal carriage of one or more colonies of vaccine-type Streptococcus pneumoniae serotypes in children and adults 24 months old or older
The outcome is determined at the individual level, through PCR microarray analysis of nasal swab samples collected during a cross-sectional, population-representative sample survey of camp residents. The analysis will be stratified by age group (24-59 months, 5 to 14 years, 15 to 29 years, 30 to 49 years, 50 years and above). Vaccine-type serotypes are defined as those that the Pneumosil vaccine (Serum Institute, India) is designed to provide immunity for, and include serotypes serotypes 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F and 23F.
Measured: 12 months, relative to baseline (pre-vaccination)
Nasopharyngeal carriage of one or more colonies of vaccine-type Streptococcus pneumoniae serotypes in children and adults 24 months old or older
The outcome is determined at the individual level, through PCR microarray analysis of nasal swab samples collected during a cross-sectional, population-representative sample survey of camp residents. The analysis will be stratified by age group (24-59 months, 5 to 14 years, 15 to 29 years, 30 to 49 years, 50 years and above). Vaccine-type serotypes are defined as those that the Pneumosil vaccine (Serum Institute, India) is designed to provide immunity for, and include serotypes serotypes 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F and 23F.
Measured: 24 months, relative to baseline (pre-vaccination)
Nasopharyngeal carriage of one or more colonies of non-vaccine-type Streptococcus pneumoniae serotypes in children and adults
The outcome is determined at the individual level, through PCR microarray analysis of nasal swab samples collected during a cross-sectional, population-representative sample survey of camp residents. The analysis will be stratified by age group (0-11 months, 12-23 months, 24-59 months, 5 to 14 years, 15 to 29 years, 30 to 49 years, 50 years and above). Non-vaccine-type serotypes are defined as those that the Pneumosil vaccine (Serum Institute, India) is not designed to provide immunity for, i.e. any serotypes other than 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F or 23F.
Measured: 6 months, relative to baseline (pre-vaccination)
Nasopharyngeal carriage of one or more colonies of non-vaccine-type Streptococcus pneumoniae serotypes in children and adults
The outcome is determined at the individual level, through PCR microarray analysis of nasal swab samples collected during a cross-sectional, population-representative sample survey of camp residents. The analysis will be stratified by age group (0-11 months, 12-23 months, 24-59 months, 5 to 14 years, 15 to 29 years, 30 to 49 years, 50 years and above). Non-vaccine-type serotypes are defined as those that the Pneumosil vaccine (Serum Institute, India) is not designed to provide immunity for, i.e. any serotypes other than 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F or 23F.
Measured: 12 months, relative to baseline (pre-vaccination)
Nasopharyngeal carriage of one or more colonies of non-vaccine-type Streptococcus pneumoniae serotypes in children and adults
The outcome is determined at the individual level, through PCR microarray analysis of nasal swab samples collected during a cross-sectional, population-representative sample survey of camp residents. The analysis will be stratified by age group (0-11 months, 12-23 months, 24-59 months, 5 to 14 years, 15 to 29 years, 30 to 49 years, 50 years and above). Non-vaccine-type serotypes are defined as those that the Pneumosil vaccine (Serum Institute, India) is not designed to provide immunity for, i.e. any serotypes other than 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F or 23F.
Measured: 24 months, relative to baseline (pre-vaccination)
Mean bacteriological density of vaccine- and non-vaccine-type Streptococcus pneumoniae infections, among children and adults with at least one infecting colony in the nasopharynx
The outcome is determined at the individual level, through PCR microarray analysis of nasal swab samples collected during a cross-sectional, population-representative sample survey of camp residents. Bacteriological density is estimated after PCR analysis as copies per milliliter. The analysis will be stratified by age group (0-11 months, 12-23 months, 24-59 months, 5 to 14 years, 15 to 29 years, 30 to 49 years, 50 years and above), and by vaccine-type versus non-vaccine-type serotype colonies. Vaccine-type serotypes are defined as those that the Pneumosil vaccine (Serum Institute, India) is designed to provide immunity for, i.e. 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F or 23F. Non-vaccine serotypes are defined as any other serotype.
Measured: 6 months, relative to baseline (pre-vaccination)
Mean bacteriological density of vaccine- and non-vaccine-type Streptococcus pneumoniae infections, among children and adults with at least one infecting colony in the nasopharynx
The outcome is determined at the individual level, through PCR microarray analysis of nasal swab samples collected during a cross-sectional, population-representative sample survey of camp residents. Bacteriological density is estimated after PCR analysis as copies per milliliter. The analysis will be stratified by age group (0-11 months, 12-23 months, 24-59 months, 5 to 14 years, 15 to 29 years, 30 to 49 years, 50 years and above), and by vaccine-type versus non-vaccine-type serotype colonies. Vaccine-type serotypes are defined as those that the Pneumosil vaccine (Serum Institute, India) is designed to provide immunity for, i.e. 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F or 23F. Non-vaccine serotypes are defined as any other serotype.
Measured: 12 months, relative to baseline (pre-vaccination)
Mean bacteriological density of vaccine- and non-vaccine-type Streptococcus pneumoniae infections, among children and adults with at least one infecting colony in the nasopharynx
The outcome is determined at the individual level, through PCR microarray analysis of nasal swab samples collected during a cross-sectional, population-representative sample survey of camp residents. Bacteriological density is estimated after PCR analysis as copies per milliliter. The analysis will be stratified by age group (0-11 months, 12-23 months, 24-59 months, 5 to 14 years, 15 to 29 years, 30 to 49 years, 50 years and above), and by vaccine-type versus non-vaccine-type serotype colonies. Vaccine-type serotypes are defined as those that the Pneumosil vaccine (Serum Institute, India) is designed to provide immunity for, i.e. 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F or 23F. Non-vaccine serotypes are defined as any other serotype.
Measured: 24 months, relative to baseline (pre-vaccination)
Incidence rate of hospitalisations due to acute lower respiratory infection (ALRI) among children aged below 2 years of age
The outcome is determined at the population level, as a rate per person-time after division by the camp's estimated population of children aged below 2 years of age, updated through exhaustive census every 6 months. Hospitalisation is defined as admission of a child residing in the camp to a paediatric inpatient facility, with a final diagnosis of acute lower respiratory infection or pneumonia. The outcome is ascertained through a manual search of registers of all paediatric facilities that the camp population can realistically utilise, complemented by perusal of outpatient register records of the camp's single primary healthcare facility, to identify instances of children referred to hospitals. The diagnosis is as per clinical records. The outcome is ascertained retrospectively at baseline (vaccination campaign), and once every 6 months post-vaccination, for 24 months. However, only results after 24 months are analysed.
Measured: 24 months, relative to baseline (pre-vaccination)
Rate of antibiotic prescription at outpatient care among children aged below 5 years of age
The outcome is determined at the aggregate (population) level, as a rate per person-time after division by the camp's estimated population of children aged below 5 years of age, which will also be updated through an exhaustive census every 6 months. The outcome is ascertained through consultation of the pharmacy register of the camp's single primary healthcare facility, by tallying the number of single prescriptions issued by the pharmacy to outpatients. Antibiotics are defined as per the World Health Organization's Model List of Essential Medicines. The outcome is ascertained retrospectively through record review conducted at baseline (vaccination campaign), and once every 6 months post-vaccination, for 24 months. However, only results after 24 months are analysed.
Measured: 24 months, relative to baseline (pre-vaccination)
Proportion of the target population who receive the specified dosing regimen of pneumococcal conjugate vaccine during the vaccination campaign
The outcome is determined at the individual level, but will be analysed at an aggregate (population) level, with stratification by age group (6 weeks to 11 months old, 12 to 23 months old, 24 to 59 months old, 5 to 14 years old). Before the vaccination campaign, all children aged 6 weeks old to 14 years old living in the camp will be systematically identified and registered. This list will serve as the denominator for the outcome, while the numerator will be children on the list who are successfully vaccinated, as per campaign administrative records. Successful vaccination is defined as injection with two doses of Pneumosil vaccine, spaced 4 weeks apart, in children aged 6 weeks to 11 months old, and one dose of Pneumosil vaccine in children aged 1 to 14 years old.
Measured: Single time point - baseline (vaccination campaign)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start27 Nov 2022
- Primary completion18 Jan 2025
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pneumococcal InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Before vs. after quasi-experimental study. Entire study population of age-eligible children will be offered the intervention.
- Masking
- None (open label)
- Enrolment
- 2,882 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Save the Children, Murdoch Childrens Research Institute, Ministry of Health Development, Somaliland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04945681
- Sponsor's protocol ID
- OPP1211787
- Acronym
- EEPICC
- Status last verified
- May 2025
- First submitted
- 14 Jun 2021
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised participant data will be deposited in a curated digital repository and made available subject to meeting access conditions.
Publications
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.
PubMed 39633426McGowan CR, van Zandvoort K, Ibrahim SA, Hassan AI, Ahmed AM, Magan MA, Muhumed MH, Mohamed MS, Cummings R, Ali SY, Mohamed MA, Saed MA, Karim MA, Hergeye MA, Flasche S, Checchi F. Safety and coverage of Pneumosil pneumococcal polysaccharide conjugate vaccine (10-valent PCV) in a camp for internally displaced persons in Somaliland. Vaccine. 2026 Jan 1;69:127991. doi: 10.1016/j.vaccine.2025.127991. Epub 2025 Nov 19.
PubMed 41265006
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of a Pneumococcal Immunisation Campaign in a Camp for Internally Displaced People: A Non-randomised, Quasi-experimental Phase IV Intervention Study
- ClinicalTrials.gov ID
- NCT04945681
- Acronym / sponsor ID
- EEPICC / OPP1211787
- Conditions
- Pneumococcal Infections
- Keywords
- Pneumococcal conjugate vaccine, Humanitarian, Crisis, Forced displacement, Mass vaccination, Quasi-experimental
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,882 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Save the Children, Murdoch Childrens Research Institute, Ministry of Health Development, Somaliland
- Study start
- 27 Nov 2022 (actual)
- Primary completion
- 18 Jan 2025 (actual)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 30 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Before vs. after quasi-experimental study. Entire study population of age-eligible children will be offered the intervention.
| Arm | Type | Receives |
|---|---|---|
| Mass vaccination | Experimental | Biological: Pneumococcal conjugate vaccineMass 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. |
Who may qualify
- Ages
- 6 weeks to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Resident in Digaale camp
- Voluntary written/thumb-printed informed consent has been provided by a parent or caregiver
- Subject's parent/caregiver must be able to comprehend and comply with study requirements and procedures
- Subject's parents/caregivers must have a readily identifiable place of residence in the study area
Key exclusion criteria (4 listed)
- Known hypersensitivity to any component of any of the EPI vaccines, including diphtheria toxoid, in the child or any sibling
- History of allergic disease or history of a serious reaction to any prior vaccination in the child or any sibling
- History of anaphylactic shock, regardless of cause
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pneumococcal conjugate vaccineMass 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. | Biological | Mass vaccination |
Primary outcome
Nasopharyngeal carriage of one or more colonies of vaccine-type Streptococcus pneumoniae serotypes in children below 24 months old
Time frame: 6 months, relative to baseline (pre-vaccination)
The outcome is determined at the individual level, through polymerase chain reaction (PCR) microarray analysis of nasal swab samples collected during a cross-sectional, population-representative sample survey of camp residents. The analysis will be stratified by age group (0-11 months, 12-23 months). Vaccine-type serotypes are defined as those that the Pneumosil vaccine (Serum Institute, India) is designed to provide immunity for, and include serotypes serotypes 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F and 23F.
Nasopharyngeal carriage of one or more colonies of vaccine-type Streptococcus pneumoniae serotypes in children below 24 months old
Time frame: 12 months, relative to baseline (pre-vaccination)
The outcome is determined at the individual level, through PCR microarray analysis of nasal swab samples collected during a cross-sectional, population-representative sample survey of camp residents. The analysis will be stratified by age group (0-11 months, 12-23 months). Vaccine-type serotypes are defined as those that the Pneumosil vaccine (Serum Institute, India) is designed to provide immunity for, and include serotypes serotypes 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F and 23F.
Nasopharyngeal carriage of one or more colonies of vaccine-type Streptococcus pneumoniae serotypes in children below 24 months old
Time frame: 24 months, relative to baseline (pre-vaccination)
The outcome is determined at the individual level, through PCR microarray analysis of nasal swab samples collected during a cross-sectional, population-representative sample survey of camp residents. The analysis will be stratified by age group (0-11 months, 12-23 months). Vaccine-type serotypes are defined as those that the Pneumosil vaccine (Serum Institute, India) is designed to provide immunity for, and include serotypes serotypes 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F and 23F.
Number and proportion of vaccination recipients who experience solicited local and systemic adverse events following immunisation (AEFI)
Time frame: within 7 days of receipt of each vaccine dose
The outcome is determined at the individual level. 'Solicited' indicates that adverse events are identified by study staff using a pre-defined checklist of signs and symptoms and proactive monitoring or follow-up of vaccine recipients. AEFI will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) (version 24.0 or later). Outcome ascertainment will occur through (i) in-person monitoring of vaccine recipients for 30 minutes after vaccine administration, and (ii) exhaustive follow-up of all vaccine recipients 7 days after vaccination, with administration of a structured questionnaire to their parents or caregivers. All AEFI will be graded using a severity scale (0 - none; 1 - mild; 2 - moderate; 3- severe; 4 - very severe; 5 - fatal), and analysis will be stratified by severity and age group (6 weeks to 11 months old, 12 to 23 months old, 24 to 59 months old).
Number and proportion of vaccination recipients who experience solicited or unsolicited severe adverse events (SAE) following vaccination
Time frame: within 7 days of receipt of each vaccine dose
The outcome is determined at the individual level. SAE are defined as any AEFI with severity >= 3. Outcome ascertainment will occur through (i) in-person monitoring of vaccine recipients for 30 min after vaccine administration, (ii) exhaustive follow-up of all vaccine recipients 7 days after vaccination, with administration of a structured questionnaire to their parents or caregivers; (iii) availability of a 24/7 phone number which caregivers of vaccine recipients will be encouraged to contact; (iv) visits to the camp's single primary healthcare facility, during each day on which vaccination takes place, to identify any children presenting for care with a SAE; and (v) availability of a 24/7 phone number which clinicians at the primary healthcare facility will be encouraged to contact. Each SAE will be followed up until resolution. Relatedness of each SAE to vaccine receipt will be classified as 'unrelated', 'unlikely', 'possible', 'probable', 'definite' and 'not assessable'.
12 secondary outcomes
Nasopharyngeal carriage of one or more colonies of vaccine-type Streptococcus pneumoniae serotypes in children and adults 24 months old or older
Time frame: 6 months, relative to baseline (pre-vaccination)
Nasopharyngeal carriage of one or more colonies of vaccine-type Streptococcus pneumoniae serotypes in children and adults 24 months old or older
Time frame: 12 months, relative to baseline (pre-vaccination)
Nasopharyngeal carriage of one or more colonies of vaccine-type Streptococcus pneumoniae serotypes in children and adults 24 months old or older
Time frame: 24 months, relative to baseline (pre-vaccination)
Nasopharyngeal carriage of one or more colonies of non-vaccine-type Streptococcus pneumoniae serotypes in children and adults
Time frame: 6 months, relative to baseline (pre-vaccination)
Nasopharyngeal carriage of one or more colonies of non-vaccine-type Streptococcus pneumoniae serotypes in children and adults
Time frame: 12 months, relative to baseline (pre-vaccination)
Nasopharyngeal carriage of one or more colonies of non-vaccine-type Streptococcus pneumoniae serotypes in children and adults
Time frame: 24 months, relative to baseline (pre-vaccination)
Mean bacteriological density of vaccine- and non-vaccine-type Streptococcus pneumoniae infections, among children and adults with at least one infecting colony in the nasopharynx
Time frame: 6 months, relative to baseline (pre-vaccination)
Mean bacteriological density of vaccine- and non-vaccine-type Streptococcus pneumoniae infections, among children and adults with at least one infecting colony in the nasopharynx
Time frame: 12 months, relative to baseline (pre-vaccination)
Mean bacteriological density of vaccine- and non-vaccine-type Streptococcus pneumoniae infections, among children and adults with at least one infecting colony in the nasopharynx
Time frame: 24 months, relative to baseline (pre-vaccination)
Incidence rate of hospitalisations due to acute lower respiratory infection (ALRI) among children aged below 2 years of age
Time frame: 24 months, relative to baseline (pre-vaccination)
Rate of antibiotic prescription at outpatient care among children aged below 5 years of age
Time frame: 24 months, relative to baseline (pre-vaccination)
Proportion of the target population who receive the specified dosing regimen of pneumococcal conjugate vaccine during the vaccination campaign
Time frame: Single time point - baseline (vaccination campaign)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Results publication: PubMed 39633426van 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.
- Derived from this study: PubMed 41265006McGowan CR, van Zandvoort K, Ibrahim SA, Hassan AI, Ahmed AM, Magan MA, Muhumed MH, Mohamed MS, Cummings R, Ali SY, Mohamed MA, Saed MA, Karim MA, Hergeye MA, Flasche S, Checchi F. Safety and coverage of Pneumosil pneumococcal polysaccharide conjugate vaccine (10-valent PCV) in a camp for internally displaced persons in Somaliland. Vaccine. 2026 Jan 1;69:127991. doi: 10.1016/j.vaccine.2025.127991. Epub 2025 Nov 19.
- Individual participant dataSharing planned: Yes. Anonymised participant data will be deposited in a curated digital repository and made available subject to meeting access conditions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pneumococcal conjugate vaccine in people with Pneumococcal Infections, run by London School of Hygiene and Tropical Medicine at 1 site in Somalia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Somalia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasopharyngeal carriage of one or more colonies of vaccine-type Streptococcus pneumoniae serotypes in children below 24 months old (time frame: 6 months, relative to baseline (pre-vaccination)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04945681, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.