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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-507293-40-00 | Registry Identifier | CTIS (EU) |
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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:
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.
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 or high-quality respiratory tract specimens, or serotype specific UAD assays performed on urine specimens. The serotype-specific UAD assays, termed UAD-1 and UAD-2, detect the 13 serotypes in 13vPnC (1, 3, 4, 5, 6A/C, 6B/D, 7F/A, 9V/A, 14, 18C/A/ B/ F, 19A, 19F, 23F) (UAD-1) and 11 additional serotypes (2, 8, 9N, 10A/39, 11A/D/F, 12F, 15B/C, 17F/A, 20A/B, 22F/A, 33F/A) (UAD-2). For the primary objective, cases will be defined as participants hospitalized for RAD+CAP in whom the 7 additional serotypes in 20vPnC beyond 13vPnC plus 15C are identified. All other participants who meet study inclusion criteria but for whom 20vPnC serotypes are not identified from any source and all other RAD+CAP of non-pneumococcal etiologies will serve as test-negative controls.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case | Cases will be defined as participants hospitalized for RAD+CAP in whom the 7 additional serotypes in 20vPnC beyond 13vPnC plus 15C are identified. |
| |
| Control | All other participants who meet study inclusion criteria but for whom 20vPnC serotypes are not identified from any source and all other RAD+CAP of non-pneumococcal etiologies will serve as test-negative controls. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic test on urine samples | Diagnostic Test | Testing by BinaxNOW® S. pneumoniae and serotype-specific urine antigen detection (UAD) assays (UAD-1 and UAD-2). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of 20vPnC against all (invasive + non-invasive) RAD+CAP due to the 7 additional serotypes in 20vPnC beyond 13vPnC plus 15C | Vaccine effectiveness as calculated as 1 minus the odds ratio for 20vPnC vaccination among cases vs. controls multiplied by 100 adjusted for potentially confounding variables | 55 months |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of 20vPnC against non-invasive RAD+CAP due to the 7 additional serotypes in 20vPnC beyond 13vPnC plus 15C | Vaccine effectiveness calculated as 1 minus the OR for 20vPnC vaccination among cases and controls multiplied by 100 adjusted for potentially confounding variables | 55 months |
| Effectiveness of 20vPnC against all RAD+CAP due to any 20vPnC serotype plus 6C and 15C |
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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:
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
Exclusion Criteria:
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Males and females ages 65 and older hospitalized for suspected community acquired pneumonia.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| El Centro Regional Medical Center | Recruiting | El Centro | California | 92243 | United States | |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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Vaccine effectiveness calculated as 1 minus the OR for 20vPnC vaccination among cases and controls multiplied by 100 adjusted for potentially confounding variables |
| 55 months |
| Effectiveness of 20vPnC against non-invasive RAD+CAP due to any 20vPnC serotype plus 6C and 15C | Vaccine effectiveness calculated as 1 minus the OR for 20vPnC vaccination among cases and controls multiplied by 100 adjusted for potentially confounding variables | 55 months |
| Proportion of participants with RAD+CAP due to the 7 additional serotypes in 20vPnC beyond 13vPnC plus 15C, individually and aggregately | The proportion of participants with RAD+CAP who are positive for any of the 7 additional serotypes contained in 20vPnC beyond 13vPnC plus 15C as detected by UAD-2 or culture | 55 months |
| The proportion of all RAD+CAP due to any 20vPnC serotype plus 6C and 15C, individually and aggregately | The proportion of participants with RAD+CAP who are positive for any of the serotypes contained in 20vPnC plus 6C and 15C as detected by UAD-1, UAD-2, or culture | 55 months |
| The proportion of all RAD+CAP due to any 13vPnC serotype plus 6C, individually and aggregately | The proportion of participants with RAD+CAP who are positive for any of the serotypes contained in 13vPnC plus 6C as detected by either UAD-1 or culture | 55 months |
| Among those positive for a serotype detected by serotype-specific UAD, the proportion of participants with any RAD+CAP due to each UAD serotype individually and aggregately | Among those positive for a serotype detected by serotype-specific UAD, the proportion of participants with RAD+CAP who are positive for any of the UAD serotypes as detected by UAD-1, UAD-2, or culture | 55 months |
| The proportion of participants with any RAD+CAP due to S. pneumoniae | The proportion of participants with RAD+CAP who have S. pneumoniae identified by culture, BinaxNOW®, or serotype-specific UADs | 55 months |
| Clinical characteristics of disease and hospitalization among those with any RAD+CAP due to all 13vPnC and/or 20vPnC serotypes plus 6C and 15C individually and aggregately | In participants with RAD+CAP, the following metrics overall, and among those positive for any of the serotypes contained in 13vPnC and/or 20vPnC plus 6C and 15C, or positive for individual serotypes contained in 13vPnC and/or 20vPnC plus 6C and 15C: • Proportion with PSI Grade I-V | 55 months |
| Clinical characteristics of disease and hospitalization among those with any RAD+CAP due to all 13vPnC and/or 20vPnC serotypes plus 6C and 15C individually and aggregately | In participants with RAD+CAP, the following metrics overall, and among those positive for any of the serotypes contained in 13vPnC and/or 20vPnC plus 6C and 15C, or positive for individual serotypes contained in 13vPnC and/or 20vPnC plus 6C and 15C: • Mean, Median, Min, and Max PSI Grade | 55 months |
| Clinical characteristics of disease and hospitalization among those with any RAD+CAP due to all 13vPnC and/or 20vPnC serotypes plus 6C and 15C individually and aggregately | In participants with RAD+CAP, the following metrics overall, and among those positive for any of the serotypes contained in 13vPnC and/or 20vPnC plus 6C and 15C, or positive for individual serotypes contained in 13vPnC and/or 20vPnC plus 6C and 15C: • Proportion in ICU | 55 months |
| Clinical characteristics of disease and hospitalization among those with any RAD+CAP due to all 13vPnC and/or 20vPnC serotypes plus 6C and 15C individually and aggregately | In participants with RAD+CAP, the following metrics overall, and among those positive for any of the serotypes contained in 13vPnC and/or 20vPnC plus 6C and 15C, or positive for individual serotypes contained in 13vPnC and/or 20vPnC plus 6C and 15C: • Mean, Median, Min, and Max length (in days) of ICU stay | 55 months |
| Clinical characteristics of disease and hospitalization among those with any RAD+CAP due to all 13vPnC and/or 20vPnC serotypes plus 6C and 15C individually and aggregately | In participants with RAD+CAP, the following metrics overall, and among those positive for any of the serotypes contained in 13vPnC and/or 20vPnC plus 6C and 15C, or positive for individual serotypes contained in 13vPnC and/or 20vPnC plus 6C and 15C: • Proportion on ventilator and by type of ventilation used | 55 months |
| Clinical characteristics of disease and hospitalization among those with any RAD+CAP due to all 13vPnC and/or 20vPnC serotypes plus 6C and 15C individually and aggregately | In participants with RAD+CAP, the following metrics overall, and among those positive for any of the serotypes contained in 13vPnC and/or 20vPnC plus 6C and 15C, or positive for individual serotypes contained in 13vPnC and/or 20vPnC plus 6C and 15C: • Mean, Median, Min, and Max length (in days) of ventilator use | 55 months |
| Clinical characteristics of disease and hospitalization among those with any RAD+CAP due to all 13vPnC and/or 20vPnC serotypes plus 6C and 15C individually and aggregately | In participants with RAD+CAP, the following metrics overall, and among those positive for any of the serotypes contained in 13vPnC and/or 20vPnC plus 6C and 15C, or positive for individual serotypes contained in 13vPnC and/or 20vPnC plus 6C and 15C: • Mean, Median, Min, and Max length (in days) of hospital stay | 55 months |
| Clinical characteristics of disease and hospitalization among those with any RAD+CAP due to all 13vPnC and/or 20vPnC serotypes plus 6C and 15C individually and aggregately | In participants with RAD+CAP, the following metrics overall, and among those positive for any of the serotypes contained in 13vPnC and/or 20vPnC plus 6C and 15C, or positive for individual serotypes contained in 13vPnC and/or 20vPnC plus 6C and 15C: • Proportion with respiratory rate ≥30 breaths/min | 55 months |
| Clinical characteristics of disease and hospitalization among those with any RAD+CAP due to all 13vPnC and/or 20vPnC serotypes plus 6C and 15C individually and aggregately | In participants with RAD+CAP, the following metrics overall, and among those positive for any of the serotypes contained in 13vPnC and/or 20vPnC plus 6C and 15C, or positive for individual serotypes contained in 13vPnC and/or 20vPnC plus 6C and 15C: • Proportion with PaO2/FiO2 ratio ≤250 | 55 months |
| Clinical characteristics of disease and hospitalization among those with any RAD+CAP due to all 13vPnC and/or 20vPnC serotypes plus 6C and 15C individually and aggregately | In participants with RAD+CAP, the following metrics overall, and among those positive for any of the serotypes contained in 13vPnC and/or 20vPnC plus 6C and 15C, or positive for individual serotypes contained in 13vPnC and/or 20vPnC plus 6C and 15C: • Proportion with each discharge disposition | 55 months |
| Kaiser Permanente Fontana Medical Center |
| Recruiting |
| Fontana |
| California |
| 92335 |
| United States |
| Kaiser Permanente West Los Angeles Medical Center | Recruiting | Los Angeles | California | 90034 | United States |
| Kaiser Permanente Vaccine Study Center | Recruiting | Oakland | California | 94612 | United States |
| Kaiser Permanente Oakland Medical Center | Recruiting | Oakland | California | 96411 | United States |
| Kaiser Permanente Ontario Medical Center | Recruiting | Ontario | California | 91761 | United States |
| Southern California Permanente Medical Group (SCPMG) | Recruiting | Pasadena | California | 91101 | United States |
| Kaiser Permanente Riverside Medical Center | Recruiting | Riverside | California | 92505 | United States |
| Kaiser Permanente Roseville Medical Center | Recruiting | Roseville | California | 95661 | United States |
| Kaiser Permanente South Sacramento Medical Center | Recruiting | Sacramento | California | 95823 | United States |
| Kaiser Permanente Sacramento Medical Center | Recruiting | Sacramento | California | 95825 | United States |
| Kaiser Permanente Zion Medical Center | Recruiting | San Diego | California | 92120 | United States |
| Kaiser Permanente San Diego Medical Center | Recruiting | San Diego | California | 92123 | United States |
| Kaiser Permanente Santa Clara Medical Center | Recruiting | Santa Clara | California | 95051 | United States |
| Kaiser Permanente South San Francisco Medical Center | Recruiting | South San Francisco | California | 94080 | United States |
| Kaiser Permanente Walnut Creek Medical Center | Recruiting | Walnut Creek | California | 94596 | United States |
| Starling Physicians | Active, not recruiting | Hartford | Connecticut | 06106 | United States |
| MedStar Washington Hospital Center | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
| Emory Children's Center - Vaccine Research Clinic (ECC-VRC) | Recruiting | Atlanta | Georgia | 30322 | United States |
| Emory University Hospital | Recruiting | Atlanta | Georgia | 30322 | United States |
| University of Louisville School of Medicine, Division of Infectious Diseases | Recruiting | Louisville | Kentucky | 40202 | United States |
| Robley Rex VA Medical Center | Recruiting | Louisville | Kentucky | 40206 | United States |
| UofL Health, Mary & Elizabeth Hospital | Recruiting | Louisville | Kentucky | 40215 | United States |
| Norton Audubon Hospital | Recruiting | Louisville | Kentucky | 40217 | United States |
| Norton Brownsboro Hospital | Recruiting | Louisville | Kentucky | 40241 | United States |
| Norton Women's and Children's Hospital | Recruiting | Louisville | Kentucky | 40241 | United States |
| Ochsner Medical Center - Kenner | Recruiting | Kenner | Louisiana | 70065 | United States |
| Ochsner Baptist Medical Center | Recruiting | New Orleans | Louisiana | 70115 | United States |
| Ochsner Clinic Foundation | Recruiting | New Orleans | Louisiana | 70121 | United States |
| University of Maryland | Recruiting | Baltimore | Maryland | 21201 | United States |
| UMass Memorial Medical Center | Recruiting | Worcester | Massachusetts | 01655 | United States |
| ECU Health Medical Center | Recruiting | Greenville | North Carolina | 27834 | United States |
| UNC Hospitals Hillsborough Campus | Recruiting | Hillsborough | North Carolina | 27278 | United States |
| Summa Health Clinical Research Center - Specialty | Recruiting | Akron | Ohio | 44304 | United States |
| Summa Health | Recruiting | Akron | Ohio | 44304 | United States |
| Ahuja Medical Center | Recruiting | Beachwood | Ohio | 44122 | United States |
| University Hospitals Cleveland Medical Center | Recruiting | Cleveland | Ohio | 44106 | United States |
| Kaiser Permanente Sunnyside Medical Center | Recruiting | Clackamas | Oregon | 97015 | United States |
| Memorial Hermann Hospital | Recruiting | Houston | Texas | 77030 | United States |
| Michael E. DeBakey VA Medical Center | Recruiting | Houston | Texas | 77030 | United States |
| Emek Medical Center | Recruiting | Afula | 1834111 | Israel |
| Soroka University Medical Center | Recruiting | Beersheba | 8410101 | Israel |
| Meir Medical Center | Recruiting | Kfar Saba | 4428164 | Israel |
| Infectious Diseases Unit Tel-Aviv Sourasky Medical Center | Recruiting | Tel Aviv | 6423906 | Israel |
| Hospital Universitari de Bellvitge | Recruiting | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Hospital Universitarios De Getafe | Recruiting | Getafe | Madrid | 28905 | Spain |
| Hospital Universitario Severo Ochoa | Recruiting | Leganés | Madrid | 28914 | Spain |
| CHUVI- Hospital Alvaro Cunqueiro | Recruiting | Vigo | Pontevedra [pontevedra] | 36312 | Spain |
| Hospital Universitari i Politecnic La Fe | Recruiting | Valencia | València | 46026 | Spain |
| Hospital Universitari Vall D´Hebron | Recruiting | Barcelona | 08035 | Spain |
| Hospital Universitario Clinico San Carlos | Recruiting | Madrid | 28040 | Spain |
| Hospital Universitario La Paz | Recruiting | Madrid | 28046 | Spain |
| Hospital Regional Universitario de Málaga | Recruiting | Málaga | 29010 | Spain |
| Hospital Universitario Doctor Peset | Recruiting | Valencia | 46017 | Spain |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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