RECRUITING

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

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.

Conditions

Study Overview

Study Details

Study overview

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.

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

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

Condition
Pneumonia
Intervention / Treatment

-

Contacts and Locations

Baldwin Park

Kaiser Permanete Baldwin Park, Baldwin Park, California, United States, 91706

Downey

Kaiser Permanete Downey, Downey, California, United States, 90242

El Centro

El Centro Regional Medical Center, El Centro, California, United States, 92243

Fontana

Kaiser Permanente Fontana Medical Center, Fontana, California, United States, 92335

Fresno

University of California San Francisco - Fresno, Fresno, California, United States, 93701

Los Angeles

Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, United States, 90027

Los Angeles

Kaiser Permanente, Los Angeles, California, United States, 90027

Los Angeles

Kaiser Permanente West Los Angeles Medical Center, Los Angeles, California, United States, 90034

Oakland

Kaiser Permanente Vaccine Study Center, Oakland, California, United States, 94612

Oakland

Kaiser Permanente Oakland Medical Center, Oakland, California, United States, 96411

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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 findings suggestive of pneumonia (rales or evidence of pulmonary consolidation including dullness on percussion, bronchial breath sounds, or egophony).
  • 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).
  • 4. Capable of giving signed informed consent
  • 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. Received any pneumococcal vaccine ≤30 days prior to enrollment.
  • 3. Unable to provide urine specimen (e.g. anuric).
  • 4. Previous enrollment in the study within the past 30 days.

Ages Eligible for Study

65 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Pfizer,

Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

2027-06-04