Phase 4
N=44,618
Mass Campaigns With Fractional Dose Pneumococcal Vaccines in Sub-Saharan Africa (fPCV)
Pneumococcal Carriage
Bottom Line
View on ClinicalTrials.gov: NCT05175014 ↗Enrolled (actual)
44,618
Serious AEs
0.2%
Results posted
Dec 2024
Primary outcome: Primary: Effect of a Single Dose PCV10 Campaign in the Reduction of VT Carriage — 4.6; 8.0; 16.5 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- PCV10 full dose (Biological); PCV10 fractional dose (Biological)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- Epicentre
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effect of a Single Dose PCV10 Campaign in the Reduction of VT Carriage |
4.6; 8.0; 16.5 | — |
| SECONDARY Vaccine Safety Monitoring |
— | — |
| SECONDARY Cost-effectiveness and Modeling |
— | — |
| SECONDARY Facilitators and Barriers to Implementing Mass Campaigns of Fractional Dose PCV |
— | — |
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. 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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05175014). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.