None listed
Conditions
Interventions
Single full dose of PCV 10
Single fractional dose of PCV10
No intervention
Sponsors
Epicentre
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Prevalence of colonization of non-VT serotypes will also be described at both timepoints. | — |
Secondary
| Measure | Time frame |
|---|---|
| Vaccine safety will be monitored up to 28 days after vaccination and all AEs and SAEs will be recorded.;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. ;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. | — |
Countries
Niger
Contacts
Public ContactOusmane Guindo
Epicentre Niger Research Center Manager
Outcome results
None listed