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
Pfizer
Summary
The purpose of this study is to learn about how well the 20-valent pneumococcal conjugate vaccine (20vPnC) works against radiologically-confirmed community-acquired pneumonia (RAD+CAP) due to the 7 new serotypes (types of a bacteria called Streptococcus pneumoniae that cause pneumonia) included in 20vPnC vaccine. This study is seeking participants who: * are male or female ≥65 years of age. * are hospitalized with physician suspicion of community acquired pneumonia (CAP). * have pneumonia confirmed with imaging like a chest x-ray Participants will be asked to provide demographic and medical history information, and to provide a urine sample that will be used to test for pneumonia caused by specific strains of a bacteria called Streptococcus pneumoniae. We will compare the proportion of participants who have pneumonia caused by specific strains of the bacteria Streptococcus pneumoniae and were previously vaccinated with 20vPnC with the proportion of participants who have pneumonia caused by something other than vaccine type Streptococcus pneumoniae and have been vaccinated with 20vPnC. Participants will actively take part in the study for about 1-2 days. Information on participant's illness and hospitalization details will be collected through day 30 of their hospitalization through medical chart review.
Description
This is an observational test-negative design study in which all study participants are adults ≥65 years of age hospitalized with RAD+CAP at one of the study sites. The only protocol-specified study procedure is a non-invasive urine specimen collection for pneumococcal detection using BinaxNOW® S. pneumoniae and the serotype-specific urinary antigen detection (UAD) assays. Cases and controls will be differentiated by the presence of vaccine serotypes that are identified by any method, including Quellung reaction of pneumococcal isolates obtained from standard of care (SOC) cultures from blood…
Eligibility
- Age range
- 65+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male or female participants ≥65 years of age. 2. 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 fin…
Interventions
- Diagnostic TestDiagnostic test on urine samples
Testing by BinaxNOW® S. pneumoniae and serotype-specific urine antigen detection (UAD) assays (UAD-1 and UAD-2).
Locations (93)
- Kaiser Permanete Baldwin ParkBaldwin Park, California
- Kaiser Permanete DowneyDowney, California
- El Centro Regional Medical CenterEl Centro, California
- Kaiser Permanente Fontana Medical CenterFontana, California
- University of California San Francisco - FresnoFresno, California
- Kaiser PermanenteLos Angeles, California