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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pneumonia
• Intervention / Treatment: Diagnostic test: Diagnostic test on urine samples

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.

• Study Type: Observational
• Enrollment (Estimated): 12500

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• Israel
  • Afula, Israel, 1834111
    • Recruiting
    • Emek Medical Center
  • Beersheba, Israel, 8410101
    • Recruiting
    • Soroka University Medical Center
  • Kfar Saba, Israel, 4428164
    • Recruiting
    • Meir Medical Center
  • Tel Aviv, Israel, 6423906
    • Recruiting
    • Infectious Diseases Unit Tel-Aviv Sourasky Medical Center
• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Universitari Vall d´Hebrón
  • Madrid, Spain, 28046
    • Recruiting
    • Hospital Universitario La Paz
  • Madrid, Spain, 28040
    • Recruiting
    • Hospital Universitario Clínico San Carlos
  • Málaga, Spain, 29010
    • Recruiting
    • Hospital Regional Universitario de Malaga
  • Valencia, Spain, 46017
    • Recruiting
    • Hospital Universitario Doctor Peset
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Recruiting
      • Hospital Universitari de Bellvitge
  • Madrid
    • Getafe, Madrid, Spain, 28905
      • Recruiting
      • Hospital Universitarios De Getafe
    • Leganés, Madrid, Spain, 28914
      • Recruiting
      • Hospital Universitario Severo Ochoa
  • Pontevedra [pontevedra]
    • Vigo, Pontevedra [pontevedra], Spain, 36312
      • Recruiting
      • CHUVI- Hospital Alvaro Cunqueiro
  • València
    • Valencia, València, Spain, 46026
      • Recruiting
      • Hospital Universitari i Politecnic La Fe
• United States
  • California
    • El Centro, California, United States, 92243
      • Recruiting
      • El Centro Regional Medical Center
    • Fontana, California, United States, 92335
      • Recruiting
      • Kaiser Permanente Fontana Medical Center
    • Los Angeles, California, United States, 90034
      • Recruiting
      • Kaiser Permanente West Los Angeles Medical Center
    • Oakland, California, United States, 96411
      • Recruiting
      • Kaiser Permanente Oakland Medical Center
    • Oakland, California, United States, 94612
      • Recruiting
      • Kaiser Permanente Vaccine Study Center
    • Ontario, California, United States, 91761
      • Recruiting
      • Kaiser Permanente Ontario Medical Center
    • Pasadena, California, United States, 91101
      • Recruiting
      • Southern California Permanente Medical Group (SCPMG)
    • Riverside, California, United States, 92505
      • Recruiting
      • Kaiser Permanente Riverside Medical Center
    • Roseville, California, United States, 95661
      • Recruiting
      • Kaiser Permanente Roseville Medical Center
    • Sacramento, California, United States, 95825
      • Recruiting
      • Kaiser Permanente Sacramento Medical Center
    • Sacramento, California, United States, 95823
      • Recruiting
      • Kaiser Permanente South Sacramento Medical Center
    • San Diego, California, United States, 92120
      • Recruiting
      • Kaiser Permanente Zion Medical Center
    • San Diego, California, United States, 92123
      • Recruiting
      • Kaiser Permanente San Diego Medical Center
    • Santa Clara, California, United States, 95051
      • Recruiting
      • Kaiser Permanente Santa Clara Medical Center
    • South San Francisco, California, United States, 94080
      • Recruiting
      • Kaiser Permanente South San Francisco Medical Center
    • Walnut Creek, California, United States, 94596
      • Recruiting
      • Kaiser Permanente Walnut Creek Medical Center
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Active, not recruiting
      • Starling Physicians
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • Recruiting
      • Medstar Washington Hospital Center
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University Hospital
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory Children's Center - Vaccine Research Clinic (ECC-VRC)
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Recruiting
      • Norton Audubon Hospital
    • Louisville, Kentucky, United States, 40241
      • Recruiting
      • Norton Brownsboro Hospital
    • Louisville, Kentucky, United States, 40206
      • Recruiting
      • Robley Rex VA Medical Center
    • Louisville, Kentucky, United States, 40202
      • Recruiting
      • University of Louisville School of Medicine, Division of Infectious Diseases
    • Louisville, Kentucky, United States, 40215
      • Recruiting
      • UofL Health, Mary & Elizabeth Hospital
    • Louisville, Kentucky, United States, 40241
      • Recruiting
      • Norton Women's and Children's Hospital
  • Louisiana
    • Kenner, Louisiana, United States, 70065
      • Recruiting
      • Ochsner Medical Center - Kenner
    • New Orleans, Louisiana, United States, 70115
      • Recruiting
      • Ochsner Baptist Medical Center
    • New Orleans, Louisiana, United States, 70121
      • Recruiting
      • Ochsner Clinic Foundation
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • University of Maryland
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • Recruiting
      • UMass Memorial Medical Center
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • Recruiting
      • ECU Health Medical Center
    • Hillsborough, North Carolina, United States, 27278
      • Recruiting
      • UNC Hospitals Hillsborough Campus
  • Ohio
    • Akron, Ohio, United States, 44304
      • Recruiting
      • Summa Health
    • Akron, Ohio, United States, 44304
      • Recruiting
      • Summa Health Clinical Research Center - Specialty
    • Beachwood, Ohio, United States, 44122
      • Recruiting
      • Ahuja Medical Center
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals Cleveland Medical Center
  • Oregon
    • Clackamas, Oregon, United States, 97015
      • Recruiting
      • Kaiser Permanente Sunnyside Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Memorial Hermann Hospital
    • Houston, Texas, United States, 77030
      • Recruiting
      • Michael E. DeBakey VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Males and females ages 65 and older hospitalized for suspected community acquired pneumonia.

Description

Inclusion 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

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: Diagnostic test on urine samples; Testing by BinaxNOW® S. pneumoniae and serotype-specific urine antigen detection (UAD) assays (UAD-1 and UAD-2).
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.	Diagnostic test: Diagnostic test on urine samples; Testing by BinaxNOW® S. pneumoniae and serotype-specific urine antigen detection (UAD) assays (UAD-1 and UAD-2).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2022
• Primary Completion (Estimated): June 4, 2027
• Study Completion (Estimated): June 4, 2027

Study Registration Dates

• First Submitted: July 6, 2022
• First Submitted That Met QC Criteria: July 6, 2022
• First Posted (Actual): July 12, 2022

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: B7471015; 2023-507293-40-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No