Mass Campaigns With Fractional Dose Pneumococcal Vaccines in Sub-Saharan Africa (fPCV) (fPCV)
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ClinicalTrials.gov Identifier: NCT05175014 |
Recruitment Status :
Active, not recruiting
First Posted : January 3, 2022
Last Update Posted : September 22, 2023
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Condition or disease | Intervention/treatment | Phase |
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Pneumococcal Carriage | Biological: PCV10 full dose Biological: PCV10 fractional dose | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 32000 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | A Phase IV, 3-arm, observer-blinded, cluster-randomized controlled trial |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Masking Description: | Vaccinators will not be blinded, but participants will not know vaccine dosage allocation. Laboratory staff (outcome assessors) will be blinded to their group allocation. |
Primary Purpose: | Prevention |
Official Title: | Determining Whether Mass Campaigns With Fractional Dose PCV10 Would Accelerate Herd Protection Against Pneumococcal Transmission in Sub-Saharan Africa |
Actual Study Start Date : | December 30, 2021 |
Actual Primary Completion Date : | May 31, 2023 |
Estimated Study Completion Date : | December 31, 2023 |
Arm | Intervention/treatment |
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Experimental: Single full dose of PCV 10
27 clusters randomized to receive a vaccination campaign with the full dose.
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Biological: PCV10 full dose
Mass vaccination campaign with one single dose PCV10 vaccine administered as a full dose. |
Experimental: Single fractional dose of PCV10 (1/5)
27 clusters randomized to receive a vaccination campaign with the fractional dose (1/5).
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Biological: PCV10 fractional dose
Mass vaccination campaign with one single dose PCV10 vaccine administered as a fractional dose. |
No Intervention: Control Group
9 clusters randomized to the control arm.
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- 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.
- Vaccine Safety Monitoring [ Time Frame: Up to 28 days after vaccination ]Vaccine safety will be monitored up to 28 days after vaccination and all AEs and SAEs will be recorded.
- Cost-effectiveness and modeling [ Time Frame: Within 2 years of study start. ]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.
- Facilitators and barriers to implementing mass campaigns of fractional dose PCV [ Time Frame: Within 2 years of study start. ]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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 1 Year to 9 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
For participation in pneumococcal carriage surveys:
Inclusion criteria:
- 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
Exclusion criteria:
- 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)
Inclusion criteria:
- 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
Exclusion criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05175014
Niger | |
Epicentre | |
Maradi, Niger |
Study Director: | Dr. Rebecca Grais | Epicentre Research Department Director | |
Principal Investigator: | Dr. Matthew Coldiron | Epicentre Research Department Investigator | |
Principal Investigator: | Dr. Issaka Soumana | Epicentre Niger Research Center Assistant Manager |
Responsible Party: | Epicentre |
ClinicalTrials.gov Identifier: | NCT05175014 |
Other Study ID Numbers: |
fPCV |
First Posted: | January 3, 2022 Key Record Dates |
Last Update Posted: | September 22, 2023 |
Last Verified: | September 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | IPD will consist of sociodemographic data collected in baseline and post-vaccination surveys, as well as results of pneumococcal isolation and serotyping. |
Time Frame: | De-identified IPD will be available after final data collection and cleaning, and once laboratory quality control procedures have been conducted. |
Access Criteria: | Any interested party may request access to the data for the purposes of secondary analysis or meta-analysis. The process for requesting data, and the criteria upon which requests will be judged are described in Epicentre Standard Operating Procedures. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |