RECRUITING

A Study to Learn About How 20-Valent Pneumococcal Conjugate Vaccine Works in a Real-world Setting

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Conditions

Pneumonia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-10-27
Study Completion:2027-06-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05452941

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male or female participants ≥65 years of age.
  2. 2. Hospitalized participant with physician clinical suspicion of CAP with the presence of ≥2 of the following 10 clinical signs or symptoms:
  3. * fever (oral temperature \>38.0°C/100.4°F or tympanic temperature \>38.5°C/101.2°F),
  4. * hypothermia (\<35.5°C/95.9°F measured by a healthcare provider)
  5. * chills or rigors,
  6. * pleuritic chest pain,
  7. * new or worsening cough,
  8. * sputum production,
  9. * dyspnea (shortness of breath),
  10. * tachypnea (respiratory rate \>20/min),
  11. * malaise, or
  12. * abnormal auscultatory findings suggestive of pneumonia (rales or evidence of pulmonary consolidation including dullness on percussion, bronchial breath sounds, or egophony).
  13. 3. 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).
  14. 4. Capable of giving signed informed consent
  1. 1. 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).
  2. 2. Received any pneumococcal vaccine ≤30 days prior to enrollment.
  3. 3. Unable to provide urine specimen (e.g. anuric).
  4. 4. Previous enrollment in the study within the past 30 days.

Contacts and Locations

Study Contact

Pfizer CT.gov Call Center
CONTACT
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Principal Investigator

Pfizer CT.gov Call Center
STUDY_DIRECTOR
Pfizer

Study Locations (Sites)

Kaiser Permanete Baldwin Park
Baldwin Park, California, 91706
United States
Kaiser Permanete Downey
Downey, California, 90242
United States
El Centro Regional Medical Center
El Centro, California, 92243
United States
Kaiser Permanente Fontana Medical Center
Fontana, California, 92335
United States
University of California San Francisco - Fresno
Fresno, California, 93701
United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
United States
Kaiser Permanente
Los Angeles, California, 90027
United States
Kaiser Permanente West Los Angeles Medical Center
Los Angeles, California, 90034
United States
Kaiser Permanente Vaccine Study Center
Oakland, California, 94612
United States
Kaiser Permanente Oakland Medical Center
Oakland, California, 96411
United States
Kaiser Permanente Ontario Medical
Ontario, California, 91761
United States
Southern California Permanente Medical Group (SCPMG)
Pasadena, California, 91101
United States
Kaiser Permanente Riverside Medical Center
Riverside, California, 92505
United States
Kaiser Permanente Roseville Medical Center
Roseville, California, 95661
United States
Kaiser Permanente South Sacramento Medical Center
Sacramento, California, 95823
United States
Kaiser Permanente Sacramento Medical Center
Sacramento, California, 95825
United States
Kaiser Permanente Zion Medical Center
San Diego, California, 92120
United States
Kaiser Permanente San Diego Medical Center
San Diego, California, 92123
United States
Kaiser Permanente San Jose Medical Center
San Jose, California, 95119
United States
Kaiser Permanente Santa Clara Medical Center
Santa Clara, California, 95051
United States
Kaiser Permanente South San Francisco Medical Center
South San Francisco, California, 94080
United States
Kaiser Permanente Walnut Creek Medical Center
Walnut Creek, California, 94596
United States
Hartford Hospital
Hartford, Connecticut, 06106
United States
Starling Physicians
Hartford, Connecticut, 06106
United States
MedStar Washington Hospital Center
Washington, District of Columbia, 20010
United States
Kindred Hospital South Florida- Ft. Lauderdale
Fort Lauderdale, Florida, 33301
United States
Alternative Research Associates
Hialeah, Florida, 33012
United States
Kindred Hospital South Florida- Hollywood
Hollywood, Florida, 33020
United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308
United States
Emory Children's Center - Vaccine Research Clinic (ECC-VRC)
Atlanta, Georgia, 30322
United States
Emory University Hospital
Atlanta, Georgia, 30322
United States
Norton Cancer Institute, Norton Healthcare Pavilion
Louisville, Kentucky, 40202
United States
Norton Hospital-Pavilion, Norton Healthcare
Louisville, Kentucky, 40202
United States
Norton Hospital
Louisville, Kentucky, 40202
United States
Norton Infectious Diseases Institute
Louisville, Kentucky, 40202
United States
University of Louisville Hospital
Louisville, Kentucky, 40202
United States
University of Louisville School of Medicine, Division of Infectious Diseases
Louisville, Kentucky, 40202
United States
UofL Health, Jewish Hospital
Louisville, Kentucky, 40202
United States
Robley Rex VA Medical Center
Louisville, Kentucky, 40206
United States
Norton Women's and Children's Hospital
Louisville, Kentucky, 40207
United States
UofL Health, Mary & Elizabeth Hospital
Louisville, Kentucky, 40215
United States
Norton Audubon Hospital
Louisville, Kentucky, 40217
United States
Norton Brownsboro Hospital
Louisville, Kentucky, 40241
United States
UofL Health, Shelbyville Hospital
Shelbyville, Kentucky, 40065
United States
UofL Health South Hospital
Shepherdsville, Kentucky, 40165
United States
Ochsner Medical Center - Kenner
Kenner, Louisiana, 70065
United States
Ochsner Baptist Medical Center
New Orleans, Louisiana, 70115
United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
United States
Ochsner Medical Center - Jefferson Highway
New Orleans, Louisiana, 70121
United States
University of Maryland
Baltimore, Maryland, 21201
United States
UMass Memorial Medical Center
Worcester, Massachusetts, 01605
United States
UMass Memorial Medical Center
Worcester, Massachusetts, 01655
United States
Henry Ford Macomb Hospital
Clinton Township, Michigan, 48038
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Ascension St. John Hospital
Grosse Pointe Woods, Michigan, 48236
United States
Henry Ford St. John Hospital
Grosse Pointe Woods, Michigan, 48236
United States
Beaumont Health Center
Royal Oak, Michigan, 48073
United States
Beaumont Infectious Diseases Research
Royal Oak, Michigan, 48073
United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322
United States
Henry Ford Wyandotte Hospital
Wyandotte, Michigan, 48192
United States
UNC Hospitals
Chapel Hill, North Carolina, 27514
United States
ECU Health Medical Center
Greenville, North Carolina, 27834
United States
The Brody School of Medicine at East California University, ECU Adult Speciality Care
Greenville, North Carolina, 27834
United States
The Brody School of Medicine at East Carolina University, ECU Adult Specialty Care
Greenville, North Carolina, 27834
United States
UNC Hospitals Hillsborough Campus
Hillsborough, North Carolina, 27278
United States
Summa Health
Akron, Ohio, 44304
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Kaiser Permanente Sunnyside Medical Center
Clackamas, Oregon, 97015
United States
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030-4211
United States
Memorial Hermann Hospital
Houston, Texas, 77030
United States
Carilion Clinic
Roanoke, Virginia, 24014
United States

Collaborators and Investigators

Sponsor: Pfizer

  • Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-27
Study Completion Date2027-06-04

Study Record Updates

Study Start Date2022-10-27
Study Completion Date2027-06-04

Terms related to this study

Additional Relevant MeSH Terms

  • Pneumonia