VACCINE EFFECTIVENESS OF 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE AGAINST VACCINE-TYPE CAP USING A TEST-NEGATIVE DESIG

Phase 1

Recruiting

• Conditions: VACCINE-TYPE RADIOLOGICALLY-CONFIRMED COMMUNITY-ACQUIRED PNEUMONIA; MedDRA version: 20.1Level: LLTClassification code: 10010120Term: Community acquired pneumonia Class: 10021881; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: CTIS2023-507293-40-00
• Lead Sponsor: Pfizer Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-31
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 12500

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified