STUDY TYPE
Real-world evidence
LOCATION
Brazil
THERAPEUTIC AREA
Dengue virus
Client Challenge
The client developed a dengue virus (DENV) vaccine, which the European Medicines Agency approved, based on Phase 3 clinical trial data. Subsequently, the client needed to evaluate the vaccine’s real-world impact in terms of reducing hospitalizations due to dengue virus infection in endemic regions where vaccination is implemented. As a CRO specializing in RWE for dengue vaccines, we supported this effort with a robust study design and expert epidemiological insights
Our solution
We designed a controlled Interrupted Time Series study using linked surveillance data to compare trends in laboratory-confirmed DENV hospitalizations before and after vaccine introduction while meticulously addressing population-level biases. Our team of epidemiologists and statisticians developed an appropriate methodological approach to answer the client’s research challenge. To support the study, we collaborated with a local dengue virus expert in Brazil who served as Principal Investigator. Together, we conducted a feasibility assessment of linked databases, and identified suitable municipalities for study implementation based on dengue virus epidemiology. Additionally, we prepared the study protocol and supporting documents, all while ensuring smooth progress through ongoing collaboration between the client, P95, and the local team.
Our IMPACT
- The local health ministry officially approved the study
- We successfully developed a comprehensive report on the background dengue virus and arbovirus incidences
- The study is currently ongoing and is supported by strong partnerships and thorough preparation. Our strong methodological and operational support ensures the study remains on track and within budget.
With our experience as a CRO specializing in RWE for dengue vaccines and a strong track record across other infectious diseases, we are ready to support your research needs. Contact us to explore how we can help.
FAQ
Here are some answers to Frequently Asked Questions.
What is the main goal of the dengue vaccine real-world evidence study in Brazil?
The study aims to measure how effectively the dengue vaccine reduces hospitalizations in a real-life, endemic setting through a controlled Interrupted Time Series design. It helps verify vaccine impact beyond controlled trial environments.
How did P95 design the study to ensure reliable, unbiased results?
P95 used linked surveillance data and selected municipalities based on dengue epidemiology, collaborated with local experts, and built a protocol that adjusts for population-level biases. They also did feasibility assessments prior to rollout.
What makes the methodology (Interrupted Time Series) appropriate for this vaccine impact evaluation?
Interrupted Time Series allows comparison of hospitalization trends before and after vaccine introduction, which helps account for existing patterns over time. By including control elements and robust surveillance data, it isolates the vaccine’s effect in context.
What are the key deliverables and current status of this dengue vaccine RWE study?
Key deliverables include feasibility findings, study protocol, background incidence reports, regulatory approval by the local health ministry, and ongoing data collection. The study is actively ongoing, with strong stakeholder partnerships in place.
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