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- PILOT: Pilot for a Test-Negative Case-Control Study to Evaluate the Effectiveness of a New Adult Pneumococcal Vaccine Against Pneumococcal Pneumonia in Older Adults
Clinical Trial
PILOT: Pilot for a Test-Negative Case-Control Study to Evaluate the Effectiveness of a New Adult Pneumococcal Vaccine Against Pneumococcal Pneumonia in Older Adults
This study will assess the completeness of vaccine history, comorbid conditions, and medical history data in collaboration with partner health systems and sites. Secondly, it aims to utilize site data to inform expected country, site selection requirements, and refine the full Test Negative Design (TND) study protocol. Finally, the study will evaluate laboratory processes, as well as imaging retrieval and file transfer capabilities, informing the feasibility and approach for the full TND study. In addition, process-oriented objectives related to site start-up activities, as well as feedback from sites on the implementation of the study will be used to identify efficiencies and improvements for the full TND study.
Eligibility Criteria
- Inclusion Criteria: 1. Male or female, ?65 years of age, at the time of signing informed consent and has given written consent to participate in the study. 2. Assessed in hospital or referred to hospital from urgent care setting with clinical suspicion of CAP (Note: Patients referred from assisted living care/centers will be eligible) 3. Meets protocol defined guidelines for CAP Exclusion Criteria: 1. Transfer from other hospitals, skilled nursing care, or acute rehabilitation 2. Protocol defined co-morbidities/medical history