Mass Campaigns With Fractional Dose Pneumococcal Vaccines in Sub-Saharan Africa (fPCV)
NCT ID: NCT05175014
Last Updated: 2024-12-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
44618 participants
INTERVENTIONAL
2021-12-30
2023-10-03
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Single full dose of PCV 10
27 clusters randomized to receive a vaccination campaign with the full dose.
PCV10 full dose
Mass vaccination campaign with one single dose PCV10 vaccine administered as a full dose.
Single fractional dose of PCV10 (1/5)
27 clusters randomized to receive a vaccination campaign with the fractional dose (1/5).
PCV10 fractional dose
Mass vaccination campaign with one single dose PCV10 vaccine administered as a fractional dose.
Control Group
9 clusters randomized to the control arm.
No interventions assigned to this group
Interventions
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PCV10 full dose
Mass vaccination campaign with one single dose PCV10 vaccine administered as a full dose.
PCV10 fractional dose
Mass vaccination campaign with one single dose PCV10 vaccine administered as a fractional dose.
Eligibility Criteria
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Inclusion Criteria
2. Residing in the villages included in the study
3. Parent or caretaker provides informed consent for the child to participate in the study
1. Aged 1-9 years
2. Residing in the villages included in the study and allocated to vaccination
3. Head of the household or main caretaker provides consent for the child to be vaccinated
Exclusion Criteria
2. 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)
1. Hypersensitivity to any component of the vaccine, including diphtheria toxoid
2. Vaccination with a PCV vaccine within the previous 4 weeks, as there should be a minimum of 4 weeks between doses
3. Moderate or severe febrile illness (temperature ≥39°C) is a temporal contraindication and the child should not be vaccinated until improvement
4. 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
1 Year
9 Years
ALL
Yes
Sponsors
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London School of Hygiene and Tropical Medicine
OTHER
Kenya Medical Research Institute
OTHER
Universite Abdou Moumouni de Niamey, Niger
OTHER
Epicentre
OTHER
Responsible Party
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Principal Investigators
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Dr. Rebecca Grais
Role: STUDY_DIRECTOR
Epicentre Research Department Director
Dr. Matthew Coldiron
Role: PRINCIPAL_INVESTIGATOR
Epicentre Research Department Investigator
Dr. Issaka Soumana
Role: PRINCIPAL_INVESTIGATOR
Epicentre Niger Research Center Assistant Manager
Locations
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Epicentre
Maradi, , Niger
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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fPCV
Identifier Type: -
Identifier Source: org_study_id