B7471015 - A PHASE 4 STUDY USING A TEST-NEGATIVE DESIGN TO EVALUATE THE EFFECTIVENESS OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE AGAINST VACCINE-TYPE RADIOLOGICALLY-CONFIRMED COMMUNITY-ACQUIRED PNEUMONIA IN ADULTS =65 YEARS OF AGE - B7471015

Pfizer Inc.0 个研究点目标入组 12,500 人开始时间: 2023年10月31日最近更新: 2024年7月22日

适应症

试验速览

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•Male or female participants =65 years of age., Hospitalized participant with physician clinical suspicion of CAP with the presence of =2 of the following 10 clinical signs or symptoms: ? fever (oral temperature >38.0°C/100.4°F or tympanic temperature >38.5°C/101.2°F), ? hypothermia (<35.5°C/95.9°F measured by a healthcare provider)? chills or rigors, ? pleuritic chest pain, ? new or worsening cough, ? sputum production, ? dyspnea (shortness of breath), ? tachypnea (respiratory rate >20/min), ? malaise, or ? abnormal auscultatory findings suggestive of pneumonia (rales or evidence of pulmonary consolidation including dullness on percussion, bronchial breath sounds, or egophony)., Has a radiographic finding that is consistent with pneumonia (e.g., pleural effusion, increased pulmonary density due to infection, the presence of alveolar infiltrates [multi-lobar, lobar, or segmental] containing air bronchograms)., Capable of giving signed informed consent as described in Appendix 1 of the Protocol, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.

•Any participant who develops signs and symptoms of pneumonia after being hospitalized for =48 hours (either at the study site, another transferring hospital, or a combination of these)., Received any pneumococcal vaccine =30 days prior to enrollment., Unable to provide urine specimen (e.g. anuric)., Previous enrollment in the study within the past 30 days.

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