Pneumococcal CarriagePhase 4fPCVNCT05175014
Mass Campaigns With Fractional Dose Pneumococcal Vaccines in Sub-Saharan Africa (fPCV)
A Phase 4 study testing PCV10 full dose and PCV10 fractional dose in people with Pneumococcal Carriage, run by Epicentre at 1 site in Niger.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Carriage
- What is being tested?
- PCV10 full dose and PCV10 fractional dose
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44,618 participants
- Where
- 1 siteNiger
- Study dates
- 30 Dec 2021to 3 Oct 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 year to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 1-9 years
- Residing in the villages included in the study
- Parent or caretaker provides informed consent for the child to participate in the study
- Aged 1-9 years
- Residing in the villages included in the study and allocated to vaccination
- Head of the household or main caretaker provides consent for the child to be vaccinated
Who cannot join
- Head or facial injuries that contraindicate nasopharyngeal swabbing
- Any condition or criteria, including acute or chronic clinically significant abnormality that in the opinion of the investigator might compromise the wellbeing of the participant or interfere with the outcome of the study
- For participation in mass vaccination campaigns (with full or fractional dose PCV10)
- Hypersensitivity to any component of the vaccine, including diphtheria toxoid
- Vaccination with a PCV vaccine within the previous 4 weeks, as there should be a minimum of 4 weeks between doses
- Moderate or severe febrile illness (temperature ≥39°C) is a temporal contraindication and the child should not be vaccinated until improvement
- Any condition or criteria, including acute or chronic clinically significant abnormality that in the opinion of the clinical staff might compromise the wellbeing of the volunteer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining Whether Mass Campaigns With Fractional Dose PCV10 Would Accelerate Herd Protection Against Pneumococcal Transmission in Sub-Saharan Africa
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.
Read the detailed description
In 2015, there were an estimated 8.9 million cases (uncertainty range 7.7-10.6 million) of clinical pneumococcal pneumonia globally, with 2.4 million cases estimated in Africa alone (uncertainty range 2.1-3.1 million). These figures represent a global reduction of 37% from 14.2 million cases (12.3 million-16.9 million) in 2000. However, pneumococcal disease continues to be a leading cause of severe disease and death representing 10% of all death in children under 5 years of age (1). These deaths occur disproportionally in low- and middle-income countries (LMICs), with approximately 50% of global pneumococcal deaths estimated to occur in 4 countries: India, Nigeria, Pakistan and the Democratic Republic of Congo.
Vaccination campaigns targeting children up to 5 years of age have an effect in the reduction of VT carriage disease. However, in crises or settings with high prevalence of malnutrition, the high pneumococcal carriage prevalence is likely to extend to older age groups. Single dose vaccination of a larger age group might be needed to control VT circulation. Currently, for GAVI-supported countries such as Niger, PCV13 vaccine has a cost of US$3 per dose. Pneumosil®, a PCV10 manufactured by Serum institute of India Ltd has the lowest price of all WHO prequalified vaccines, at US$2 per dose.
Mass campaigns targeting large groups require many doses and might not be sustainable over time. Fractional doses of PCV could be a solution to overcome the high PCV costs, increase vaccine access and expand vaccination benefits through alternative strategies. The study population (ages 1-9) stems from an LSHTM modelling study.
Objectives of the study Primary objective: evaluate whether the full dose of PCV is superior to the absence of vaccine and then if a single 20% dose of PCV is non-inferior to a full dose in carriage reduction.
Secondary objectives:
- To measure the age-stratified prevalence of NP carriage of S. pneumoniae in children 1-9 years of age in the study area.
- To determine the impact of a mass vaccination campaign with one full dose of PCV in children 1 to 9 years of age on VT pneumococci carriage 6 months after vaccination
- To assess the occurrence of adverse events (AE) and serious adverse events (SAE) during 28 days after administration of fractional and full doses and SAEs throughout the duration of follow-up
- To model the potential impact of fractional dose PCV campaigns in other contexts using the results of the clinical trial.
- To develop recommendations on how a potential future fractional dose PCV mass campaign could be successfully planned, communicated, delivered, and integrated into national immunization programmes using qualitative analysis.
Note: the 1-9 years age group targeted for the mass campaign is based on data from a model in Kilifi, Kenya. Baseline carriage survey data together with data will be used on interactions between age groups and PCV coverage data collected during the baseline survey, to estimate the age group that should be targeted for vaccination.
Methodology A cluster-randomized, blinded, non-inferiority trial will be implemented in rural villages of the Madarounfa District of Niger. Clusters will be randomized to full dose, fractional dose or control arm in 2:2:1 allocation ratio. Clusters will be composed of a village or group of neighbouring villages that share a school or market. Stratified randomization will be used to consider size of clusters and proximity to health centre. Vaccination will target all children aged approximately 1 to 9 years of age residing in the selected villages Prior to the mass vaccination campaign, a cross-sectional survey will be implemented to estimate community-level carriage of VT pneumococci, as well as to collect data on household composition, social interactions and PCV vaccination coverage.
- Conditions
- Pneumococcal Carriage
- Being tested
- PCV10 full dose, PCV10 fractional dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCV10 full doseBiological
Mass vaccination campaign with one single dose PCV10 vaccine administered as a full dose.
PCV10 fractional doseBiological
Mass vaccination campaign with one single dose PCV10 vaccine administered as a fractional dose.
| Study group | Role | What they receive |
|---|---|---|
| Single full dose of PCV 10 | Experimental | 27 clusters randomized to receive a vaccination campaign with the full dose. Receives: Biological: PCV10 full dose |
| Single fractional dose of PCV10 (1/5) | Experimental | 27 clusters randomized to receive a vaccination campaign with the fractional dose (1/5). Receives: Biological: PCV10 fractional dose |
| Control Group | No intervention | 9 clusters randomized to the control arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of a Single Dose PCV10 Campaign in the Reduction of VT Carriage
The effect of a single dose PCV10 campaign in the reduction of VT carriage will be assessed by: first, assessing the superiority of a campaign using full doses of PCV10 compared to control group without vaccination; and second, by establishing the non-inferiority of a campaign using fractional doses of PCV10 compared to a campaign using full doses. NP carriage will be measured in the 3 study arms (full dose arm, fractional dose arm and control arm) in a baseline survey implemented prior to the vaccination campaign and in a post-vaccination survey. The NP carriage of VT S. pneumoniae will be measured as the proportion of participants that are colonized with any of the 10 serotypes covered by PCV10 at each time point. The reduction in NP carriage will be calculated by comparing the proportion of children carrying VT pneumococci 6 months post-vaccination to baseline, at the time of vaccination. The prevalence of colonization of non-VT serotypes will also be described at both timepoints.
Measured: During three months of vaccination campaign, and 6 months post-vaccination campaign
Secondary outcomes (3)
Vaccine Safety Monitoring
Vaccine safety will be monitored up to 28 days after vaccination and all AEs and SAEs will be recorded.
Measured: Up to 28 days after vaccination
Cost-effectiveness and Modeling
An age-structured, dynamic, deterministic model of pneumococcal transmission will be constructed to estimate the impact of mass fractional dose PCV campaigns on VT carriage. The model will use the data on social interactions between age groups and PCV coverage estimates collected during the baseline survey as well as the results of the VT carriage from the baseline survey. Based on the modeled epidemiological impact of PCV10 mass campaigns, with both full and fractional doses, a cost-effectiveness analysis will be performed to estimate the incremental cost-effectiveness ratio of routine PCV10 mass campaigns. The modeled epidemiological impact and cost-effectiveness of a fractional dose mass campaign will be used to inform ongoing discussions of dose-sparing strategies and the use of single-dose fractional PCV in acute humanitarian emergencies.
Measured: Within 2 years of study start.
Facilitators and Barriers to Implementing Mass Campaigns of Fractional Dose PCV
A qualitative study will be conducted among parents, healthcare workers, national and international stakeholders to develop insights and recommendations on how a potential future fractional dose PCV mass campaign could be successfully planned, communicated, delivered and integrated into national immunization programs.
Measured: Within 2 years of study start.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2022
- Study start30 Dec 2021
- Primary completion14 Mar 2023
- Study completion3 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pneumococcal CarriageStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Phase IV, 3-arm, observer-blinded, cluster-randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44,618 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epicentre
- Sponsor type
- University, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, Kenya Medical Research Institute, Universite Abdou Moumouni de Niamey, Niger
- Responsible party
- Sponsor
- Investigators
- Dr. Rebecca Grais, Study director, Epicentre Research Department DirectorDr. Matthew Coldiron, Principal investigator, Epicentre Research Department InvestigatorDr. Issaka Soumana, Principal investigator, Epicentre Niger Research Center Assistant Manager
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05175014
- Sponsor's protocol ID
- fPCV
- Acronym
- fPCV
- Status last verified
- Nov 2024
- First submitted
- 13 Dec 2021
- Last updated
- 5 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will consist of sociodemographic data collected in baseline and post-vaccination surveys, as well as results of pneumococcal isolation and serotyping.
Publications
Coldiron ME, Soumana I, Baudin E, Langendorf C, Mamiafo Tchoula C, Brah S, Karani A, Gallagher KE, Kagucia EW, Scott JAG, Grais RF. Effect of mass campaigns with full and fractional doses of pneumococcal conjugate vaccine (Pneumosil) on the reduction of nasopharyngeal pneumococcal carriage in Niger: a three-arm, open-label, cluster-randomised trial. Lancet Infect Dis. 2025 Jun;25(6):634-642. doi: 10.1016/S1473-3099(24)00719-9. Epub 2025 Jan 8.
PubMed 39798587
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Whether Mass Campaigns With Fractional Dose PCV10 Would Accelerate Herd Protection Against Pneumococcal Transmission in Sub-Saharan Africa
- ClinicalTrials.gov ID
- NCT05175014
- Acronym / sponsor ID
- fPCV / fPCV
- Conditions
- Pneumococcal Carriage
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44,618 participants (actual)
- Lead sponsor
- EpicentreUniversity, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, Kenya Medical Research Institute, Universite Abdou Moumouni de Niamey, Niger
- Study start
- 30 Dec 2021 (actual)
- Primary completion
- 14 Mar 2023 (actual)
- Study completion
- 3 Oct 2023 (actual)
- First posted
- 3 Jan 2022 (actual)
- Results
- Posted 5 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In 2015, there were an estimated 8.9 million cases (uncertainty range 7.7-10.6 million) of clinical pneumococcal pneumonia globally, with 2.4 million cases estimated in Africa alone (uncertainty range 2.1-3.1 million). These figures represent a global reduction of 37% from 14.2 million cases (12.3 million-16.9 million) in 2000. However, pneumococcal disease continues to be a leading cause of severe disease and death representing 10% of all death in children under 5 years of age (1). These deaths occur disproportionally in low- and middle-income countries (LMICs), with approximately 50% of global pneumococcal deaths estimated to occur in 4 countries: India, Nigeria, Pakistan and the Democratic Republic of Congo.
Vaccination campaigns targeting children up to 5 years of age have an effect in the reduction of VT carriage disease. However, in crises or settings with high prevalence of malnutrition, the high pneumococcal carriage prevalence is likely to extend to older age groups. Single dose vaccination of a larger age group might be needed to control VT circulation. Currently, for GAVI-supported countries such as Niger, PCV13 vaccine has a cost of US$3 per dose. Pneumosil®, a PCV10 manufactured by Serum institute of India Ltd has the lowest price of all WHO prequalified vaccines, at US$2 per dose.
Mass campaigns targeting large groups require many doses and might not be sustainable over time. Fractional doses of PCV could be a solution to overcome the high PCV costs, increase vaccine access and expand vaccination benefits through alternative strategies. The study population (ages 1-9) stems from an LSHTM modelling study.
Objectives of the study Primary objective: evaluate whether the full dose of PCV is superior to the absence of vaccine and then if a single 20% dose of PCV is non-inferior to a full dose in carriage reduction.
Secondary objectives:
- To measure the age-stratified prevalence of NP carriage of S. pneumoniae in children 1-9 years of age in the study area.
- To determine the impact of a mass vaccination campaign with one full dose of PCV in children 1 to 9 years of age on VT pneumococci carriage 6 months after vaccination
- To assess the occurrence of adverse events (AE) and serious adverse events (SAE) during 28 days after administration of fractional and full doses and SAEs throughout the duration of follow-up
- To model the potential impact of fractional dose PCV campaigns in other contexts using the results of the clinical trial.
- To develop recommendations on how a potential future fractional dose PCV mass campaign could be successfully planned, communicated, delivered, and integrated into national immunization programmes using qualitative analysis.
Note: the 1-9 years age group targeted for the mass campaign is based on data from a model in Kilifi, Kenya. Baseline carriage survey data together with data will be used on interactions between age groups and PCV coverage data collected during the baseline survey, to estimate the age group that should be targeted for vaccination.
Methodology A cluster-randomized, blinded, non-inferiority trial will be implemented in rural villages of the Madarounfa District of Niger. Clusters will be randomized to full dose, fractional dose or control arm in 2:2:1 allocation ratio. Clusters will be composed of a village or group of neighbouring villages that share a school or market. Stratified randomization will be used to consider size of clusters and proximity to health centre. Vaccination will target all children aged approximately 1 to 9 years of age residing in the selected villages Prior to the mass vaccination campaign, a cross-sectional survey will be implemented to estimate community-level carriage of VT pneumococci, as well as to collect data on household composition, social interactions and PCV vaccination coverage.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A Phase IV, 3-arm, observer-blinded, cluster-randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Single full dose of PCV 10 | Experimental | Biological: PCV10 full dose27 clusters randomized to receive a vaccination campaign with the full dose. |
| Single fractional dose of PCV10 (1/5) | Experimental | Biological: PCV10 fractional dose27 clusters randomized to receive a vaccination campaign with the fractional dose (1/5). |
| Control Group | No intervention | –9 clusters randomized to the control arm. |
Who may qualify
- Ages
- 1 year to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Aged 1-9 years
- Residing in the villages included in the study
- Parent or caretaker provides informed consent for the child to participate in the study
- Aged 1-9 years
- Residing in the villages included in the study and allocated to vaccination
Key exclusion criteria (7 listed)
- Head or facial injuries that contraindicate nasopharyngeal swabbing
- Any condition or criteria, including acute or chronic clinically significant abnormality that in the opinion of the investigator might compromise the wellbeing of the participant or interfere with the outcome of the study
- For participation in mass vaccination campaigns (with full or fractional dose PCV10)
- Hypersensitivity to any component of the vaccine, including diphtheria toxoid
- Vaccination with a PCV vaccine within the previous 4 weeks, as there should be a minimum of 4 weeks between doses
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 |
|---|---|---|
| PCV10 full doseMass vaccination campaign with one single dose PCV10 vaccine administered as a full dose. | Biological | Single full dose of PCV 10 |
| PCV10 fractional doseMass vaccination campaign with one single dose PCV10 vaccine administered as a fractional dose. | Biological | Single fractional dose of PCV10 (1/5) |
Primary outcome
Effect of a Single Dose PCV10 Campaign in the Reduction of VT Carriage
Time frame: During three months of vaccination campaign, and 6 months post-vaccination campaign
The effect of a single dose PCV10 campaign in the reduction of VT carriage will be assessed by: first, assessing the superiority of a campaign using full doses of PCV10 compared to control group without vaccination; and second, by establishing the non-inferiority of a campaign using fractional doses of PCV10 compared to a campaign using full doses. NP carriage will be measured in the 3 study arms (full dose arm, fractional dose arm and control arm) in a baseline survey implemented prior to the vaccination campaign and in a post-vaccination survey. The NP carriage of VT S. pneumoniae will be measured as the proportion of participants that are colonized with any of the 10 serotypes covered by PCV10 at each time point. The reduction in NP carriage will be calculated by comparing the proportion of children carrying VT pneumococci 6 months post-vaccination to baseline, at the time of vaccination. The prevalence of colonization of non-VT serotypes will also be described at both timepoints.
3 secondary outcomes
Vaccine Safety Monitoring
Time frame: Up to 28 days after vaccination
Cost-effectiveness and Modeling
Time frame: Within 2 years of study start.
Facilitators and Barriers to Implementing Mass Campaigns of Fractional Dose PCV
Time frame: Within 2 years of study start.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39798587Coldiron ME, Soumana I, Baudin E, Langendorf C, Mamiafo Tchoula C, Brah S, Karani A, Gallagher KE, Kagucia EW, Scott JAG, Grais RF. Effect of mass campaigns with full and fractional doses of pneumococcal conjugate vaccine (Pneumosil) on the reduction of nasopharyngeal pneumococcal carriage in Niger: a three-arm, open-label, cluster-randomised trial. Lancet Infect Dis. 2025 Jun;25(6):634-642. doi: 10.1016/S1473-3099(24)00719-9. Epub 2025 Jan 8.
- Individual participant dataSharing planned: Yes. IPD will consist of sociodemographic data collected in baseline and post-vaccination surveys, as well as results of pneumococcal isolation and serotyping.
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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.
Dr. Rebecca Grais study director
Epicentre Research Department Director
Dr. Matthew Coldiron principal investigator
Epicentre Research Department Investigator
Dr. Issaka Soumana principal investigator
Epicentre Niger Research Center Assistant Manager
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 PCV10 full dose and PCV10 fractional dose in people with Pneumococcal Carriage, run by Epicentre at 1 site in Niger.
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 6 inclusion and 7 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: finished, as of the sponsor's last update on 5 Dec 2024. 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 Niger. 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?
Yes. Results are posted in the registry (first posted 5 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Effect of a Single Dose PCV10 Campaign in the Reduction of VT Carriage (time frame: During three months of vaccination campaign, and 6 months post-vaccination campaign). 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 NCT05175014, which also lists 1 linked publication.
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 5 Dec 2024.