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

Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05452941
• Other study ID #: B7471015
• Status: Recruiting
• Start date: October 27, 2022
• Est. completion date: June 4, 2027

Study information

• Verified date: June 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12500
• Est. completion date: June 4, 2027
• Est. primary completion date: June 4, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pneumonia

Intervention

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).

Locations

Country	Name	City	State
Israel	Emek Medical Center	Afula
Israel	Samson Assuta Ashdod University Hospital	Ashdod
Israel	Soroka University Medical Center	Be'er Sheva
Israel	Rambam Health Care Campus	Haifa
Israel	Meir Medical Center	Kfar Saba
Israel	Rabin Medical Center	Petah Tikva
Israel	The Chaim Sheba Medical Center	Ramat - Gan
Israel	The Chaim Sheba Medical Center	Ramat-Gan
Israel	Tel-Aviv Sourasky Medical Center	Tel Aviv
Israel	Infectious Diseases Unit Tel-Aviv Sourasky Medical Center	Tel-Aviv
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital Universitarios De Getafe	Getafe
Spain	Hospital Universitarios De Getafe	Getafe	Madrid
Spain	Hospital General Universitario Gregorio Marañón	Madrid
Spain	Hospital Universitario Clinico San Carlos	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Regional Universitario de Málaga	Málaga
Spain	Hospital Universitario de Móstoles	Móstoles	Madrid
Spain	Hospital Universitario Rey Juan Carlos	Móstoles	Madrid
United States	Summa Health	Akron	Ohio
United States	Emory Children's Center - Vaccine Research Clinic (ECC-VRC)	Atlanta	Georgia
United States	Emory University Hospital	Atlanta	Georgia
United States	Emory University Hospital Midtown	Atlanta	Georgia
United States	Kaiser Permanete Baldwin Park	Baldwin Park	California
United States	UNC Hospitals	Chapel Hill	North Carolina
United States	Kaiser Permanente Sunnyside Medical Center	Clackamas	Oregon
United States	Henry Ford Macomb Hospital	Clinton Township	Michigan
United States	Henry Ford Hospital	Detroit	Michigan
United States	Kaiser Permanete Downey	Downey	California
United States	El Centro Regional Medical Center	El Centro	California
United States	Kaiser Permanente Fontana Medical Center	Fontana	California
United States	Kindred Hospital South Florida- Ft. Lauderdale	Fort Lauderdale	Florida
United States	ECU Health Medical Center	Greenville	North Carolina
United States	The Brody School of Medicine at East California University, ECU Adult Speciality Care	Greenville	North Carolina
United States	The Brody School of Medicine at East Carolina University, ECU Adult Specialty Care	Greenville	North Carolina
United States	Ascension St. John Hospital	Grosse Pointe Woods	Michigan
United States	Hartford Hospital	Hartford	Connecticut
United States	Starling Physicians	Hartford	Connecticut
United States	Alternative Research Associates	Hialeah	Florida
United States	UNC Hospitals Hillsborough Campus	Hillsborough	North Carolina
United States	Kindred Hospital South Florida- Hollywood	Hollywood	Florida
United States	Memorial Hermann Hospital	Houston	Texas
United States	Michael E. DeBakey VA Medical Center	Houston	Texas
United States	Ochsner Medical Center - Kenner	Kenner	Louisiana
United States	Kaiser Permanente	Los Angeles	California
United States	Kaiser Permanente Los Angeles Medical Center	Los Angeles	California
United States	Norton Audubon Hospital	Louisville	Kentucky
United States	Norton Brownsboro Hospital	Louisville	Kentucky
United States	Norton Cancer Institute, Norton Healthcare Pavilion	Louisville	Kentucky
United States	Norton Hospital	Louisville	Kentucky
United States	Norton Infectious Diseases Institute	Louisville	Kentucky
United States	Norton Women's and Children's Hospital	Louisville	Kentucky
United States	Robley Rex VA Medical Center	Louisville	Kentucky
United States	University of Louisville Hospital	Louisville	Kentucky
United States	University of Louisville School of Medicine, Division of Infectious Diseases	Louisville	Kentucky
United States	UofL Health, Jewish Hospital	Louisville	Kentucky
United States	UofL Health, Mary & Elizabeth Hospital	Louisville	Kentucky
United States	Ochsner Baptist Medical Center	New Orleans	Louisiana
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Ochsner Medical Center - Jefferson Highway	New Orleans	Louisiana
United States	Kaiser Permanente Oakland Medical Center	Oakland	California
United States	Kaiser Permanente Vaccine Study Center	Oakland	California
United States	Kaiser Permanente Ontario Medical	Ontario	California
United States	Southern California Permanente Medical Group (SCPMG)	Pasadena	California
United States	Kaiser Permanente Riverside Medical Center	Riverside	California
United States	Kaiser Permanente Roseville Medical Center	Roseville	California
United States	Beaumont Health Center	Royal Oak	Michigan
United States	Beaumont Infectious Diseases Research	Royal Oak	Michigan
United States	Kaiser Permanente Sacramento Medical Center	Sacramento	California
United States	Kaiser Permanente South Sacramento Medical Center	Sacramento	California
United States	Kaiser Permanente San Diego Medical Center	San Diego	California
United States	Kaiser Permanente Zion Medical Center	San Diego	California
United States	Kaiser Permanente San Jose Medical Center	San Jose	California
United States	Kaiser Permanente Santa Clara Medical Center	Santa Clara	California
United States	UofL Health, Shelbyville Hospital	Shelbyville	Kentucky
United States	Kaiser Permanente South San Francisco Medical Center	South San Francisco	California
United States	Kaiser Permanente Walnut Creek Medical Center	Walnut Creek	California
United States	MedStar Washington Hospital Center	Washington	District of Columbia
United States	Henry Ford West Bloomfield Hospital	West Bloomfield	Michigan
United States	UMass Memorial Medical Center	Worcester	Massachusetts
United States	UMass Memorial Medical Center	Worcester	Massachusetts
United States	Henry Ford Wyandotte Hospital	Wyandotte	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Israel,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

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