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

NCT05452941 | Recruiting FDA Drug

• 2 other identifiers: B74710152023-507293-40-00
• Study Type: observational
• Target: 12,500
• Locations: 3 countries
• Sites: 54

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.

Conditions

Pneumonia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• Effectiveness of 20vPnC against non-invasive RAD+CAP due to the 7 additional serotypes in 20vPnC beyond 13vPnC plus 15C

  55 months

• Effectiveness of 20vPnC against all RAD+CAP due to any 20vPnC serotype plus 6C and 15C

  55 months

• Effectiveness of 20vPnC against non-invasive RAD+CAP due to any 20vPnC serotype plus 6C and 15C

  55 months

• 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 all RAD+CAP due to any 20vPnC serotype plus 6C and 15C, individually and aggregately

  55 months

Study Arms (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

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

Interventions

Diagnostic test on urine samples DIAGNOSTIC_TEST

Testing by BinaxNOW® S. pneumoniae and serotype-specific urine antigen detection (UAD) assays (UAD-1 and UAD-2).

Case; Control

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (54)

El Centro Regional Medical Center

El Centro, California, 92243, United States

RECRUITING

Kaiser Permanente Fontana Medical Center

Fontana, California, 92335, United States

RECRUITING

Kaiser Permanente West Los Angeles Medical Center

Los Angeles, California, 90034, United States

RECRUITING

Kaiser Permanente Vaccine Study Center

Oakland, California, 94612, United States

RECRUITING

Kaiser Permanente Oakland Medical Center

Oakland, California, 96411, United States

RECRUITING

Kaiser Permanente Ontario Medical Center

Ontario, California, 91761, United States

RECRUITING

Southern California Permanente Medical Group (SCPMG)

Pasadena, California, 91101, United States

RECRUITING

Kaiser Permanente Riverside Medical Center

Riverside, California, 92505, United States

RECRUITING

Kaiser Permanente Roseville Medical Center

Roseville, California, 95661, United States

RECRUITING

Kaiser Permanente South Sacramento Medical Center

Sacramento, California, 95823, United States

RECRUITING

Kaiser Permanente Sacramento Medical Center

Sacramento, California, 95825, United States

RECRUITING

Kaiser Permanente Zion Medical Center

San Diego, California, 92120, United States

RECRUITING

Kaiser Permanente San Diego Medical Center

San Diego, California, 92123, United States

RECRUITING

Kaiser Permanente Santa Clara Medical Center

Santa Clara, California, 95051, United States

RECRUITING

Kaiser Permanente South San Francisco Medical Center

South San Francisco, California, 94080, United States

RECRUITING

Kaiser Permanente Walnut Creek Medical Center

Walnut Creek, California, 94596, United States

RECRUITING

Starling Physicians

Hartford, Connecticut, 06106, United States

ACTIVE NOT RECRUITING

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

RECRUITING

Emory Children's Center - Vaccine Research Clinic (ECC-VRC)

Atlanta, Georgia, 30322, United States

RECRUITING

Emory University Hospital

Atlanta, Georgia, 30322, United States

RECRUITING

University of Louisville School of Medicine, Division of Infectious Diseases

Louisville, Kentucky, 40202, United States

RECRUITING

Robley Rex VA Medical Center

Louisville, Kentucky, 40206, United States

RECRUITING

UofL Health, Mary & Elizabeth Hospital

Louisville, Kentucky, 40215, United States

RECRUITING

Norton Audubon Hospital

Louisville, Kentucky, 40217, United States

RECRUITING

Norton Brownsboro Hospital

Louisville, Kentucky, 40241, United States

RECRUITING

Norton Women's and Children's Hospital

Louisville, Kentucky, 40241, United States

RECRUITING

Ochsner Medical Center - Kenner

Kenner, Louisiana, 70065, United States

RECRUITING

Ochsner Baptist Medical Center

New Orleans, Louisiana, 70115, United States

RECRUITING

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

RECRUITING

University of Maryland

Baltimore, Maryland, 21201, United States

RECRUITING

UMass Memorial Medical Center

Worcester, Massachusetts, 01655, United States

RECRUITING

ECU Health Medical Center

Greenville, North Carolina, 27834, United States

RECRUITING

UNC Hospitals Hillsborough Campus

Hillsborough, North Carolina, 27278, United States

RECRUITING

Summa Health Clinical Research Center - Specialty

Akron, Ohio, 44304, United States

RECRUITING

Summa Health

Akron, Ohio, 44304, United States

RECRUITING

Ahuja Medical Center

Beachwood, Ohio, 44122, United States

RECRUITING

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

Kaiser Permanente Sunnyside Medical Center

Clackamas, Oregon, 97015, United States

RECRUITING

Memorial Hermann Hospital

Houston, Texas, 77030, United States

RECRUITING

Michael E. DeBakey VA Medical Center

Houston, Texas, 77030, United States

RECRUITING

Emek Medical Center

Afula, 1834111, Israel

RECRUITING

Soroka University Medical Center

Beersheba, 8410101, Israel

RECRUITING

Meir Medical Center

Kfar Saba, 4428164, Israel

RECRUITING

Infectious Diseases Unit Tel-Aviv Sourasky Medical Center

Tel Aviv, 6423906, Israel

RECRUITING

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

RECRUITING

Hospital Universitarios De Getafe

Getafe, Madrid, 28905, Spain

RECRUITING

Hospital Universitario Severo Ochoa

Leganés, Madrid, 28914, Spain

RECRUITING

CHUVI- Hospital Alvaro Cunqueiro

Vigo, Pontevedra [pontevedra], 36312, Spain

RECRUITING

Hospital Universitari i Politecnic La Fe

Valencia, València, 46026, Spain

RECRUITING

Hospital Universitari Vall D´Hebron

Barcelona, 08035, Spain

RECRUITING

Hospital Universitario Clinico San Carlos

Madrid, 28040, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, 28046, Spain

RECRUITING

Hospital Regional Universitario de Málaga

Málaga, 29010, Spain

RECRUITING

Hospital Universitario Doctor Peset

Valencia, 46017, Spain

RECRUITING

Related Links

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

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: observational
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 12, 2022
• Study Start: October 27, 2022
• Primary Completion (Estimated): June 4, 2027
• Study Completion (Estimated): June 4, 2027
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

IL (4); US (40); ES (10)