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

Status: Recruiting
Location: See all (91) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Kaiser Permanete Baldwin Park
RECRUITING
Baldwin Park
Kaiser Permanete Downey
RECRUITING
Downey
El Centro Regional Medical Center
RECRUITING
El Centro
Kaiser Permanente Fontana Medical Center
RECRUITING
Fontana
University of California San Francisco - Fresno
RECRUITING
Fresno
Kaiser Permanente
RECRUITING
Los Angeles
Kaiser Permanente Los Angeles Medical Center
RECRUITING
Los Angeles
Kaiser Permanente West Los Angeles Medical Center
RECRUITING
Los Angeles
Kaiser Permanente Oakland Medical Center
RECRUITING
Oakland
Kaiser Permanente Vaccine Study Center
RECRUITING
Oakland
Kaiser Permanente Ontario Medical
RECRUITING
Ontario
Southern California Permanente Medical Group (SCPMG)
RECRUITING
Pasadena
Kaiser Permanente Riverside Medical Center
RECRUITING
Riverside
Kaiser Permanente Roseville Medical Center
RECRUITING
Roseville
Kaiser Permanente Sacramento Medical Center
RECRUITING
Sacramento
Kaiser Permanente South Sacramento Medical Center
RECRUITING
Sacramento
Kaiser Permanente San Diego Medical Center
RECRUITING
San Diego
Kaiser Permanente Zion Medical Center
RECRUITING
San Diego
Kaiser Permanente San Jose Medical Center
RECRUITING
San Jose
Kaiser Permanente Santa Clara Medical Center
RECRUITING
Santa Clara
Kaiser Permanente South San Francisco Medical Center
RECRUITING
South San Francisco
Kaiser Permanente Walnut Creek Medical Center
RECRUITING
Walnut Creek
Connecticut
Hartford Hospital
ACTIVE_NOT_RECRUITING
Hartford
Starling Physicians
ACTIVE_NOT_RECRUITING
Hartford
Washington, D.c.
MedStar Washington Hospital Center
RECRUITING
Washington D.c.
Georgia
Emory Children's Center - Vaccine Research Clinic (ECC-VRC)
RECRUITING
Atlanta
Emory University Hospital
RECRUITING
Atlanta
Emory University Hospital Midtown
RECRUITING
Atlanta
Indiana
Norton Clark Hospital
RECRUITING
Jeffersonville
Kentucky
Norton Audubon Hospital
RECRUITING
Louisville
Norton Brownsboro Hospital
RECRUITING
Louisville
Norton Hospital
RECRUITING
Louisville
Norton Hospital-Pavilion, Norton Healthcare
RECRUITING
Louisville
Norton Infectious Diseases Institute
RECRUITING
Louisville
Norton Women's and Children's Hospital
RECRUITING
Louisville
Robley Rex VA Medical Center
RECRUITING
Louisville
University of Louisville Hospital
RECRUITING
Louisville
University of Louisville School of Medicine, Division of Infectious Diseases
RECRUITING
Louisville
UofL Health, Jewish Hospital
RECRUITING
Louisville
UofL Health, Mary & Elizabeth Hospital
RECRUITING
Louisville
UofL Health, Shelbyville Hospital
RECRUITING
Shelbyville
UofL Health South Hospital
RECRUITING
Shepherdsville
Louisiana
Ochsner Medical Center - Kenner
RECRUITING
Kenner
Ochsner Baptist Medical Center
RECRUITING
New Orleans
Ochsner Clinic Foundation
RECRUITING
New Orleans
Massachusetts
UMass Memorial Medical Center
RECRUITING
Worcester
UMass Memorial Medical Center
RECRUITING
Worcester
Maryland
University of Maryland
RECRUITING
Baltimore
Michigan
Henry Ford Macomb Hospital
RECRUITING
Clinton Township
Henry Ford Hospital
RECRUITING
Detroit
Ascension St. John Hospital
RECRUITING
Grosse Pointe Woods
Henry Ford St. John Hospital
RECRUITING
Grosse Pointe Woods
Beaumont Health Center
RECRUITING
Royal Oak
Beaumont Infectious Diseases Research
RECRUITING
Royal Oak
Henry Ford West Bloomfield Hospital
RECRUITING
West Bloomfield
Henry Ford Wyandotte Hospital
RECRUITING
Wyandotte
North Carolina
UNC Hospitals
RECRUITING
Chapel Hill
ECU Health Medical Center
RECRUITING
Greenville
The Brody School of Medicine at East Carolina University, ECU Adult Specialty Care
RECRUITING
Greenville
UNC Hospitals Hillsborough Campus
RECRUITING
Hillsborough
Ohio
Summa Health
RECRUITING
Akron
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
Oregon
Kaiser Permanente Sunnyside Medical Center
RECRUITING
Clackamas
Texas
Memorial Hermann Hospital
RECRUITING
Houston
Michael E. DeBakey VA Medical Center
RECRUITING
Houston
Virginia
Carilion Clinic
RECRUITING
Roanoke
Other Locations
Israel
Emek Medical Center
RECRUITING
Afula
Samson Assuta Ashdod University Hospital
RECRUITING
Ashdod
Soroka University Medical Center
RECRUITING
Beersheba
Rambam Health Care Campus
RECRUITING
Haifa
The Edith Wolfson Medical Center
RECRUITING
Holon
Meir Medical Center
RECRUITING
Kfar Saba
Rabin Medical Center
RECRUITING
Petah Tikva
The Chaim Sheba Medical Center
RECRUITING
Ramat Gan
Infectious Diseases Unit Tel-Aviv Sourasky Medical Center
RECRUITING
Tel Aviv
Spain
Hospital Clinic de Barcelona
RECRUITING
Barcelona
Hospital Universitari Vall D´Hebron
RECRUITING
Barcelona
Hospital Universitarios De Getafe
RECRUITING
Getafe
Hospital Universitari de Bellvitge
RECRUITING
L'hospitalet De Llobregat
Hospital Universitario Severo Ochoa
RECRUITING
Leganés
Hospital General Universitario Gregorio Marañón
RECRUITING
Madrid
Hospital Universitario Clinico San Carlos
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Regional Universitario de Málaga
RECRUITING
Málaga
Hospital Universitario de Móstoles
RECRUITING
Móstoles
Hospital Universitario Rey Juan Carlos
RECRUITING
Móstoles
Consorcio Hospital General Universitario de Valencia
NOT_YET_RECRUITING
Valencia
Hospital Clínico Universitario de Valencia
NOT_YET_RECRUITING
Valencia
Hospital Universitari i Politecnic La Fe
RECRUITING
Valencia
Hospital Universitario Doctor Peset
NOT_YET_RECRUITING
Valencia
CHUVI- Hospital Alvaro Cunqueiro
RECRUITING
Vigo
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2022-10-27
Estimated Completion Date: 2027-06-04
Participants
Target number of participants: 12500
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov