Clinical trial NCT05452941: A Study to Learn About How 20-Valent Pneumococcal Conjugate Vaccine Works in a Real-world Setting
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pneumonia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-07-12
Enrollment: 12500
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males and females ages 65 and older hospitalized for suspected community acquired pneumonia.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Effectiveness of 20vPnC against all (invasive + non-invasive) RAD+CAP due to the 7 additional serotypes in 20vPnC beyond 13vPnC plus 15C
timeFrame: 55 months
Secondary outcomes:
measure: Effectiveness of 20vPnC against non-invasive RAD+CAP due to the 7 additional serotypes in 20vPnC beyond 13vPnC plus 15C
timeFrame: 55 months
measure: Effectiveness of 20vPnC against all RAD+CAP due to any 20vPnC serotype plus 6C and 15C
timeFrame: 55 months
measure: Effectiveness of 20vPnC against non-invasive RAD+CAP due to any 20vPnC serotype plus 6C and 15C
timeFrame: 55 months
measure: Proportion of participants with RAD+CAP due to the 7 additional serotypes in 20vPnC beyond 13vPnC plus 15C, individually and aggregately
timeFrame: 55 months
measure: The proportion of all RAD+CAP due to any 20vPnC serotype plus 6C and 15C, individually and aggregately
timeFrame: 55 months
measure: The proportion of all RAD+CAP due to any 13vPnC serotype plus 6C, individually and aggregately
timeFrame: 55 months
measure: 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
timeFrame: 55 months
measure: The proportion of participants with any RAD+CAP due to S. pneumoniae
timeFrame: 55 months
measure: 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
timeFrame: 55 months
measure: 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
timeFrame: 55 months
measure: 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
timeFrame: 55 months
measure: 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
timeFrame: 55 months
measure: 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
timeFrame: 55 months
measure: 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
timeFrame: 55 months
measure: 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
timeFrame: 55 months
measure: 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
timeFrame: 55 months
measure: 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
timeFrame: 55 months
measure: 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
timeFrame: 55 months
Other outcomes:
Locations:
city: Baldwin Park
country: United States
facility: Kaiser Permanete Baldwin Park
state: California
city: Downey
country: United States
facility: Kaiser Permanete Downey
state: California
city: El Centro
country: United States
facility: El Centro Regional Medical Center
state: California
city: Fontana
country: United States
facility: Kaiser Permanente Fontana Medical Center
state: California
city: Fresno
country: United States
facility: University of California San Francisco - Fresno
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles Medical Center
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente West Los Angeles Medical Center
state: California
city: Oakland
country: United States
facility: Kaiser Permanente Vaccine Study Center
state: California
city: Oakland
country: United States
facility: Kaiser Permanente Oakland Medical Center
state: California
city: Ontario
country: United States
facility: Kaiser Permanente Ontario Medical
state: California
city: Pasadena
country: United States
facility: Southern California Permanente Medical Group (SCPMG)
state: California
city: Riverside
country: United States
facility: Kaiser Permanente Riverside Medical Center
state: California
city: Roseville
country: United States
facility: Kaiser Permanente Roseville Medical Center
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente South Sacramento Medical Center
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente Sacramento Medical Center
state: California
city: San Diego
country: United States
facility: Kaiser Permanente Zion Medical Center
state: California
city: San Diego
country: United States
facility: Kaiser Permanente San Diego Medical Center
state: California
city: San Jose
country: United States
facility: Kaiser Permanente San Jose Medical Center
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente Santa Clara Medical Center
state: California
city: South San Francisco
country: United States
facility: Kaiser Permanente South San Francisco Medical Center
state: California
city: Walnut Creek
country: United States
facility: Kaiser Permanente Walnut Creek Medical Center
state: California
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Hartford
country: United States
facility: Starling Physicians
state: Connecticut
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Emory Children's Center - Vaccine Research Clinic (ECC-VRC)
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Louisville
country: United States
facility: Norton Hospital-Pavilion, Norton Healthcare
state: Kentucky
city: Louisville
country: United States
facility: Norton Hospital
state: Kentucky
city: Louisville
country: United States
facility: Norton Infectious Diseases Institute
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville Hospital
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville School of Medicine, Division of Infectious Diseases
state: Kentucky
city: Louisville
country: United States
facility: UofL Health, Jewish Hospital
state: Kentucky
city: Louisville
country: United States
facility: Robley Rex VA Medical Center
state: Kentucky
city: Louisville
country: United States
facility: Norton Women's and Children's Hospital
state: Kentucky
city: Louisville
country: United States
facility: UofL Health, Mary & Elizabeth Hospital
state: Kentucky
city: Louisville
country: United States
facility: Norton Audubon Hospital
state: Kentucky
city: Louisville
country: United States
facility: Norton Brownsboro Hospital
state: Kentucky
city: Shelbyville
country: United States
facility: UofL Health, Shelbyville Hospital
state: Kentucky
city: Shepherdsville
country: United States
facility: UofL Health South Hospital
state: Kentucky
city: Kenner
country: United States
facility: Ochsner Medical Center - Kenner
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Baptist Medical Center
state: Louisiana
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Clinton Township
country: United States
facility: Henry Ford Macomb Hospital
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Grosse Pointe Woods
country: United States
facility: Ascension St. John Hospital
state: Michigan
city: Grosse Pointe Woods
country: United States
facility: Henry Ford St. John Hospital
state: Michigan
city: Royal Oak
country: United States
facility: Beaumont Health Center
state: Michigan
city: Royal Oak
country: United States
facility: Beaumont Infectious Diseases Research
state: Michigan
city: West Bloomfield
country: United States
facility: Henry Ford West Bloomfield Hospital
state: Michigan
city: Wyandotte
country: United States
facility: Henry Ford Wyandotte Hospital
state: Michigan
city: Chapel Hill
country: United States
facility: UNC Hospitals
state: North Carolina
city: Greenville
country: United States
facility: ECU Health Medical Center
state: North Carolina
city: Greenville
country: United States
facility: The Brody School of Medicine at East Carolina University, ECU Adult Specialty Care
state: North Carolina
city: Hillsborough
country: United States
facility: UNC Hospitals Hillsborough Campus
state: North Carolina
city: Akron
country: United States
facility: Summa Health
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Clackamas
country: United States
facility: Kaiser Permanente Sunnyside Medical Center
state: Oregon
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center
state: Texas
city: Roanoke
country: United States
facility: Carilion Clinic
state: Virginia
city: Afula
country: Israel
facility: Emek Medical Center
city: Ashdod
country: Israel
facility: Samson Assuta Ashdod University Hospital
city: Be'er Sheva
country: Israel
facility: Soroka University Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Holon
country: Israel
facility: The Edith Wolfson Medical Center
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Ramat - Gan
country: Israel
facility: The Chaim Sheba Medical Center
city: Tel-Aviv
country: Israel
facility: Infectious Diseases Unit Tel-Aviv Sourasky Medical Center
city: L´Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: Leganés
country: Spain
facility: Hospital Universitario Severo Ochoa
state: Madrid
city: Móstoles
country: Spain
facility: Hospital Universitario Rey Juan Carlos
state: Madrid
city: Móstoles
country: Spain
facility: Hospital Universitario de Móstoles
state: Madrid
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
state: València
city: Barcelona
country: Spain
facility: Hospital Universitari Vall D´Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Getafe
country: Spain
facility: Hospital Universitarios De Getafe
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: