VACCINE EFFECTIVENESS OF 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE AGAINST VACCINE-TYPE CAP USING A TEST-NEGATIVE DESIGN
EU CTIS ID: 2023-507293-40-00
What this study is testing
To determine the effectiveness of 20vPnC against all RAD+CAP due to any 20vPnC serotype plus 6C and 15C.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.