PneumoniaNCT05452941
A Study to Learn About How 20-Valent Pneumococcal Conjugate Vaccine Works in a Real-world Setting
An observational study of Pneumonia, run by Pfizer at 54 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Pneumonia
- What is being tested?
- Diagnostic test on urine samples
- How many people
- 12,500 participants
- Where
- 54 sitesin 3 countries
- Study dates
- 27 Oct 2022to 4 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Males and females ages 65 and older hospitalized for suspected community acquired pneumonia.
Who may be able to join
- 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,
Show all 14Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
54 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
54 sites in 3 countries
United States40 sites, 39 recruiting
- Recruiting
Summa Health Clinical Research Center - Specialty
Akron, Ohio, 44304
- Recruiting
Summa Health
Akron, Ohio, 44304
- Recruiting
Emory Children's Center - Vaccine Research Clinic (ECC-VRC)
Atlanta, Georgia, 30322
- Recruiting
Emory University Hospital
Atlanta, Georgia, 30322
- Recruiting
University of Maryland
Baltimore, Maryland, 21201
- Recruiting
Ahuja Medical Center
Beachwood, Ohio, 44122
- Recruiting
Kaiser Permanente Sunnyside Medical Center
Clackamas, Oregon, 97015
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
- Recruiting
El Centro Regional Medical Center
El Centro, California, 92243
- Recruiting
Kaiser Permanente Fontana Medical Center
Fontana, California, 92335
- Recruiting
ECU Health Medical Center
Greenville, North Carolina, 27834
- Active, not recruiting
Starling Physicians
Hartford, Connecticut, 06106
- Recruiting
UNC Hospitals Hillsborough Campus
Hillsborough, North Carolina, 27278
- Recruiting
Memorial Hermann Hospital
Houston, Texas, 77030
- Recruiting
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
- Recruiting
Ochsner Medical Center - Kenner
Kenner, Louisiana, 70065
- Recruiting
Kaiser Permanente West Los Angeles Medical Center
Los Angeles, California, 90034
- Recruiting
University of Louisville School of Medicine, Division of Infectious Diseases
Louisville, Kentucky, 40202
- Recruiting
Robley Rex VA Medical Center
Louisville, Kentucky, 40206
- Recruiting
UofL Health, Mary & Elizabeth Hospital
Louisville, Kentucky, 40215
- Recruiting
Norton Audubon Hospital
Louisville, Kentucky, 40217
- Recruiting
Norton Brownsboro Hospital
Louisville, Kentucky, 40241
- Recruiting
Norton Women's and Children's Hospital
Louisville, Kentucky, 40241
- Recruiting
Ochsner Baptist Medical Center
New Orleans, Louisiana, 70115
- Recruiting
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
- Recruiting
Kaiser Permanente Vaccine Study Center
Oakland, California, 94612
- Recruiting
Kaiser Permanente Oakland Medical Center
Oakland, California, 96411
- Recruiting
Kaiser Permanente Ontario Medical Center
Ontario, California, 91761
- Recruiting
Southern California Permanente Medical Group (SCPMG)
Pasadena, California, 91101
- Recruiting
Kaiser Permanente Riverside Medical Center
Riverside, California, 92505
- Recruiting
Kaiser Permanente Roseville Medical Center
Roseville, California, 95661
- Recruiting
Kaiser Permanente South Sacramento Medical Center
Sacramento, California, 95823
- Recruiting
Kaiser Permanente Sacramento Medical Center
Sacramento, California, 95825
- Recruiting
Kaiser Permanente Zion Medical Center
San Diego, California, 92120
- Recruiting
Kaiser Permanente San Diego Medical Center
San Diego, California, 92123
- Recruiting
Kaiser Permanente Santa Clara Medical Center
Santa Clara, California, 95051
- Recruiting
Kaiser Permanente South San Francisco Medical Center
South San Francisco, California, 94080
- Recruiting
Kaiser Permanente Walnut Creek Medical Center
Walnut Creek, California, 94596
- Recruiting
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
- Recruiting
UMass Memorial Medical Center
Worcester, Massachusetts, 01655
Spain10 sites, 10 recruiting
- Recruiting
Hospital Universitari Vall D´Hebron
Barcelona, 08035
- Recruiting
Hospital Universitarios De Getafe
Getafe, Madrid, 28905
- Recruiting
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
- Recruiting
Hospital Universitario Severo Ochoa
Leganés, Madrid, 28914
- Recruiting
Hospital Universitario Clinico San Carlos
Madrid, 28040
- Recruiting
Hospital Universitario La Paz
Madrid, 28046
- Recruiting
Hospital Regional Universitario de Málaga
Málaga, 29010
- Recruiting
Hospital Universitari i Politecnic La Fe
Valencia, València, 46026
- Recruiting
Hospital Universitario Doctor Peset
Valencia, 46017
- Recruiting
CHUVI- Hospital Alvaro Cunqueiro
Vigo, Pontevedra [pontevedra], 36312
Israel4 sites, 4 recruiting
- Recruiting
Emek Medical Center
Afula, 1834111
- Recruiting
Soroka University Medical Center
Beersheba, 8410101
- Recruiting
Meir Medical Center
Kfar Saba, 4428164
- Recruiting
Infectious Diseases Unit Tel-Aviv Sourasky Medical Center
Tel Aviv, 6423906
About this study
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
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:
Read more
- 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.
Read the 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.
- Conditions
- Pneumonia
- Being tested
- Diagnostic test on urine samples
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic test on urine samplesDiagnostic test
Testing by BinaxNOW® S. pneumoniae and serotype-specific urine antigen detection (UAD) assays (UAD-1 and UAD-2).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Diagnostic test on urine samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Vaccine effectiveness calculated as 1 minus the OR for 20vPnC vaccination among cases and controls multiplied by 100 adjusted for potentially confounding variables
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 55 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start27 Oct 2022
- Primary completion4 Jun 2027 (estimated)
- Study completion4 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 12,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05452941
- Sponsor's protocol ID
- B7471015
- Other IDs
- 2023-507293-40-00, 2023
- Status last verified
- May 2026
- First submitted
- 6 Jul 2022
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05452941
- Acronym / sponsor ID
- B7471015
- Conditions
- Pneumonia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 12,500 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2022 (actual)
- Primary completion
- 4 Jun 2027 (estimated)
- Study completion
- 4 Jun 2027 (estimated)
- First posted
- 12 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Diagnostic Test: Diagnostic test on urine samplesCases will be defined as participants hospitalized for RAD+CAP in whom the 7 additional serotypes in 20vPnC beyond 13vPnC plus 15C are identified. |
| Control | – | Diagnostic Test: Diagnostic test on urine samplesAll 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Males and females ages 65 and older hospitalized for suspected community acquired pneumonia.
Key inclusion criteria (14 listed)
- 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:
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic test on urine samplesTesting by BinaxNOW® S. pneumoniae and serotype-specific urine antigen detection (UAD) assays (UAD-1 and UAD-2). | Diagnostic test | Case, Control |
Primary outcome
Effectiveness of 20vPnC against all (invasive + non-invasive) RAD+CAP due to the 7 additional serotypes in 20vPnC beyond 13vPnC plus 15C
Time frame: 55 months
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
18 secondary outcomes
Effectiveness of 20vPnC against non-invasive RAD+CAP due to the 7 additional serotypes in 20vPnC beyond 13vPnC plus 15C
Time frame: 55 months
Effectiveness of 20vPnC against all RAD+CAP due to any 20vPnC serotype plus 6C and 15C
Time frame: 55 months
Effectiveness of 20vPnC against non-invasive RAD+CAP due to any 20vPnC serotype plus 6C and 15C
Time frame: 55 months
Proportion of participants with RAD+CAP due to the 7 additional serotypes in 20vPnC beyond 13vPnC plus 15C, individually and aggregately
Time frame: 55 months
The proportion of all RAD+CAP due to any 20vPnC serotype plus 6C and 15C, individually and aggregately
Time frame: 55 months
The proportion of all RAD+CAP due to any 13vPnC serotype plus 6C, individually and aggregately
Time frame: 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
Time frame: 55 months
The proportion of participants with any RAD+CAP due to S. pneumoniae
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 55 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Pneumonia
Not yet recruiting
Modified Inhaled Nitric Oxide in Ventilated Patients With Acute Respiratory Failure
Acute Respiratory Failure (ARF), Nitric Oxide
Not yet recruitingPhase 1/2
A Study of Sequential Therapy With AHB-137 Injection Followed by TVAX-008 Injection in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B
Recruiting
Uncovering the Mechanism of Pain Relief by Peripheral Transcutaneous Magnetic Stimulation
Post-Surgical Pain, Chronic, Post-traumatic Pain, Chronic
Active, not recruitingPhase 1
Trial to Evaluate Safety and Immune Response of an Investigational Pneumococcal Vaccine in Adults Aged 50 To 64 Years
Pneumonia, Bacterial
RecruitingObservational study
Pneumonia and Pleuropneumonia in Hospitalized Children
Pneumonia, Pleural Effusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pfizer CT.gov Call Center study director
Pfizer
54 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia, run by Pfizer at 54 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States, Spain, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of 20vPnC against all (invasive + non-invasive) RAD+CAP due to the 7 additional serotypes in 20vPnC beyond 13vPnC plus 15C (time frame: 55 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.