A Study to Learn About How 20-Valent Pneumococcal Conjugate Vaccine Works in a Real-world Setting
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05452941 |
Recruitment Status :
Recruiting
First Posted : July 12, 2022
Last Update Posted : May 20, 2024
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition or disease | Intervention/treatment |
---|---|
Pneumonia | Diagnostic Test: Diagnostic test on urine samples |
Study Type : | Observational |
Estimated Enrollment : | 12500 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
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 |
Actual Study Start Date : | October 27, 2022 |
Estimated Primary Completion Date : | June 4, 2027 |
Estimated Study Completion Date : | June 4, 2027 |
Group/Cohort | Intervention/treatment |
---|---|
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). |
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). |
- 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
- Effectiveness of 20vPnC against non-invasive RAD+CAP due to the 7 additional serotypes in 20vPnC beyond 13vPnC plus 15C [ Time Frame: 55 months ]Vaccine effectiveness calculated as 1 minus the OR for 20vPnC vaccination among cases and controls multiplied by 100 adjusted for potentially confounding variables
- Effectiveness of 20vPnC against all RAD+CAP due to any 20vPnC serotype plus 6C and 15C [ Time Frame: 55 months ]Vaccine effectiveness calculated as 1 minus the OR for 20vPnC vaccination among cases and controls multiplied by 100 adjusted for potentially confounding variables
- Effectiveness of 20vPnC against non-invasive RAD+CAP due to any 20vPnC serotype plus 6C and 15C [ Time Frame: 55 months ]Vaccine effectiveness calculated as 1 minus the OR for 20vPnC vaccination among cases and controls multiplied by 100 adjusted for potentially confounding variables
- 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 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
- 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 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
- The proportion of all RAD+CAP due to any 13vPnC serotype plus 6C, individually and aggregately [ Time Frame: 55 months ]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
- 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 ]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
- The proportion of participants with any RAD+CAP due to S. pneumoniae [ Time Frame: 55 months ]The proportion of participants with RAD+CAP who have S. pneumoniae identified by culture, BinaxNOW®, or serotype-specific UADs
- 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 ]
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
- 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 ]
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
- 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 ]
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
- 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 ]
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
- 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 ]
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
- 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 ]
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
- 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 ]
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
- 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 ]
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
- 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 ]
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
- 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 ]
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
Biospecimen Retention: Samples Without DNA
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 65 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05452941
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer |
ClinicalTrials.gov Identifier: | NCT05452941 |
Other Study ID Numbers: |
B7471015 |
First Posted: | July 12, 2022 Key Record Dates |
Last Update Posted: | May 20, 2024 |
Last Verified: | May 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
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. |
URL: | https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Pneumonia Respiratory Tract Infections Infections Lung Diseases Respiratory Tract Diseases |