A Study to Learn About How 20-Valent Pneumococcal Conjugate Vaccine Works in a Real-world Setting
- Conditions
- Pneumonia
- Interventions
- Diagnostic Test: Diagnostic test on urine samples
- Registration Number
- NCT05452941
- Lead Sponsor
- Pfizer
- Brief 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.
- Detailed 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 12500
-
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
- 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
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Case Diagnostic test on urine samples 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 Diagnostic test on urine samples 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.
- Primary Outcome Measures
Name Time Method Effectiveness of 20vPnC against all (invasive + non-invasive) RAD+CAP due to the 7 additional serotypes in 20vPnC beyond 13vPnC plus 15C 55 months 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
- Secondary Outcome Measures
Name Time Method 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 55 months 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 dispositionEffectiveness of 20vPnC against non-invasive RAD+CAP due to any 20vPnC serotype plus 6C and 15C 55 months Vaccine effectiveness calculated as 1 minus the OR for 20vPnC vaccination among cases and controls multiplied by 100 adjusted for potentially confounding variables
The proportion of all RAD+CAP due to any 20vPnC serotype plus 6C and 15C, individually and aggregately 55 months 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
Effectiveness of 20vPnC against non-invasive RAD+CAP due to the 7 additional serotypes in 20vPnC beyond 13vPnC plus 15C 55 months Vaccine effectiveness calculated as 1 minus the OR for 20vPnC vaccination among cases and controls multiplied by 100 adjusted for potentially confounding variables
Effectiveness of 20vPnC against all RAD+CAP due to any 20vPnC serotype plus 6C and 15C 55 months Vaccine effectiveness calculated as 1 minus the OR for 20vPnC vaccination among cases and controls multiplied by 100 adjusted for potentially confounding variables
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 55 months 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
The proportion of participants with any RAD+CAP due to S. pneumoniae 55 months The proportion of participants with RAD+CAP who have S. pneumoniae identified by culture, BinaxNOW®, or serotype-specific UADs
Proportion of participants with RAD+CAP due to the 7 additional serotypes in 20vPnC beyond 13vPnC plus 15C, individually and aggregately 55 months 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
The proportion of all RAD+CAP due to any 13vPnC serotype plus 6C, individually and aggregately 55 months 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
Trial Locations
- Locations (85)
Hospital Universitari i Politecnic La Fe
🇪🇸Valencia, València, Spain
Kaiser Permanete Baldwin Park
🇺🇸Baldwin Park, California, United States
Kaiser Permanete Downey
🇺🇸Downey, California, United States
El Centro Regional Medical Center
🇺🇸El Centro, California, United States
Kaiser Permanente Fontana Medical Center
🇺🇸Fontana, California, United States
University of California San Francisco - Fresno
🇺🇸Fresno, California, United States
Kaiser Permanente Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
Kaiser Permanente
🇺🇸Los Angeles, California, United States
Kaiser Permanente West Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
Kaiser Permanente Vaccine Study Center
🇺🇸Oakland, California, United States
Kaiser Permanente Oakland Medical Center
🇺🇸Oakland, California, United States
Kaiser Permanente Ontario Medical
🇺🇸Ontario, California, United States
Southern California Permanente Medical Group (SCPMG)
🇺🇸Pasadena, California, United States
Kaiser Permanente Riverside Medical Center
🇺🇸Riverside, California, United States
Kaiser Permanente Roseville Medical Center
🇺🇸Roseville, California, United States
Kaiser Permanente South Sacramento Medical Center
🇺🇸Sacramento, California, United States
Kaiser Permanente Sacramento Medical Center
🇺🇸Sacramento, California, United States
Kaiser Permanente Zion Medical Center
🇺🇸San Diego, California, United States
Kaiser Permanente San Diego Medical Center
🇺🇸San Diego, California, United States
Kaiser Permanente San Jose Medical Center
🇺🇸San Jose, California, United States
Kaiser Permanente Santa Clara Medical Center
🇺🇸Santa Clara, California, United States
Kaiser Permanente South San Francisco Medical Center
🇺🇸South San Francisco, California, United States
Kaiser Permanente Walnut Creek Medical Center
🇺🇸Walnut Creek, California, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Starling Physicians
🇺🇸Hartford, Connecticut, United States
MedStar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Emory University Hospital Midtown
🇺🇸Atlanta, Georgia, United States
Emory Children's Center - Vaccine Research Clinic (ECC-VRC)
🇺🇸Atlanta, Georgia, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Norton Hospital-Pavilion, Norton Healthcare
🇺🇸Louisville, Kentucky, United States
Norton Hospital
🇺🇸Louisville, Kentucky, United States
Norton Infectious Diseases Institute
🇺🇸Louisville, Kentucky, United States
University of Louisville Hospital
🇺🇸Louisville, Kentucky, United States
University of Louisville School of Medicine, Division of Infectious Diseases
🇺🇸Louisville, Kentucky, United States
UofL Health, Jewish Hospital
🇺🇸Louisville, Kentucky, United States
Robley Rex VA Medical Center
🇺🇸Louisville, Kentucky, United States
Norton Women's and Children's Hospital
🇺🇸Louisville, Kentucky, United States
UofL Health, Mary & Elizabeth Hospital
🇺🇸Louisville, Kentucky, United States
Norton Audubon Hospital
🇺🇸Louisville, Kentucky, United States
Norton Brownsboro Hospital
🇺🇸Louisville, Kentucky, United States
UofL Health, Shelbyville Hospital
🇺🇸Shelbyville, Kentucky, United States
UofL Health South Hospital
🇺🇸Shepherdsville, Kentucky, United States
Ochsner Medical Center - Kenner
🇺🇸Kenner, Louisiana, United States
Ochsner Baptist Medical Center
🇺🇸New Orleans, Louisiana, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
UMass Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Henry Ford Macomb Hospital
🇺🇸Clinton Township, Michigan, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Ascension St. John Hospital
🇺🇸Grosse Pointe Woods, Michigan, United States
Henry Ford St. John Hospital
🇺🇸Grosse Pointe Woods, Michigan, United States
Beaumont Health Center
🇺🇸Royal Oak, Michigan, United States
Beaumont Infectious Diseases Research
🇺🇸Royal Oak, Michigan, United States
Henry Ford West Bloomfield Hospital
🇺🇸West Bloomfield, Michigan, United States
Henry Ford Wyandotte Hospital
🇺🇸Wyandotte, Michigan, United States
UNC Hospitals
🇺🇸Chapel Hill, North Carolina, United States
ECU Health Medical Center
🇺🇸Greenville, North Carolina, United States
The Brody School of Medicine at East Carolina University, ECU Adult Specialty Care
🇺🇸Greenville, North Carolina, United States
UNC Hospitals Hillsborough Campus
🇺🇸Hillsborough, North Carolina, United States
Summa Health
🇺🇸Akron, Ohio, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Kaiser Permanente Sunnyside Medical Center
🇺🇸Clackamas, Oregon, United States
Memorial Hermann Hospital
🇺🇸Houston, Texas, United States
Michael E. DeBakey VA Medical Center
🇺🇸Houston, Texas, United States
Carilion Clinic
🇺🇸Roanoke, Virginia, United States
Emek Medical Center
🇮🇱Afula, Israel
Samson Assuta Ashdod University Hospital
🇮🇱Ashdod, Israel
Soroka University Medical Center
🇮🇱Be'er Sheva, Israel
Rambam Health Care Campus
🇮🇱Haifa, Israel
The Edith Wolfson Medical Center
🇮🇱Holon, Israel
Meir Medical Center
🇮🇱Kfar Saba, Israel
Rabin Medical Center
🇮🇱Petah Tikva, Israel
The Chaim Sheba Medical Center
🇮🇱Ramat - Gan, Israel
Infectious Diseases Unit Tel-Aviv Sourasky Medical Center
🇮🇱Tel-Aviv, Israel
Hospital Universitari de Bellvitge
🇪🇸L´Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Severo Ochoa
🇪🇸Leganés, Madrid, Spain
Hospital Universitario Rey Juan Carlos
🇪🇸Móstoles, Madrid, Spain
Hospital Universitario de Móstoles
🇪🇸Móstoles, Madrid, Spain
Hospital Universitari Vall D´Hebron
🇪🇸Barcelona, Spain
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Hospital Universitarios De Getafe
🇪🇸Getafe, Spain
Hospital General Universitario Gregorio Marañón
🇪🇸Madrid, Spain
Hospital Universitario Clinico San Carlos
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Regional Universitario de Málaga
🇪🇸Málaga, Spain