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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 3, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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) .

This study is seeking participants who:

  • are male or female ≥65 years of age.
  • are hospitalized with physician suspicion of community acquired pneumonia (CAP).

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. We will compare how many participants have pneumonia and were previously vaccinated with 20vPnC with how many participants who have pneumonia and have not 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

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
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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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.
 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).


Outcome Measures
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Primary Outcome Measures :
  1. Vaccine effectiveness calculated as 1 minus the odds ratio for 20vPnC vaccination among cases vs. controls multiplied by 100 adjusted for potentially confounding variables. [ Time Frame: 55 months ]

Secondary Outcome Measures :
  1. Vaccine effectiveness calculated as 1 minus the odds ratio for 20vPnC vaccination among cases and controls multiplied by 100 adjusted for potentially confounding variables. [ Time Frame: 55 months ]
  2. 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. [ Time Frame: 55 months ]
  3. 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 [ Time Frame: 55 months ]
  4. 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. [ Time Frame: 55 months ]
  5. 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. [ Time Frame: 55 months ]
  6. The proportion of participants with RAD+CAP who have S. pneumoniae identified by culture, BinaxNOW®, or serotype-specific UADs. [ Time Frame: 55 months ]
  7. 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 ]

Biospecimen Retention:   Samples Without DNA
Non-invasive urine specimens will be collected for pneumococcal detection using BinaxNOW® S. pneumoniae and serotype-specific urinary antigen detection assays.

Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Males and females ages 65 and older hospitalized for suspected community acquired pneumonia.
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05452941    
Other Study ID Numbers: B7471015
First Posted: July 12, 2022    Key Record Dates
Last Update Posted: May 3, 2023
Last Verified: May 2023
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia
Respiratory Tract Infections
Infections
Lung Diseases
Respiratory Tract Diseases