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| ID | Type | Description | Link |
|---|---|---|---|
| CIBELES | Other Identifier | Alias Study Number |
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Low interventional, prospective, multicentre, hospital-based study involving adults 60 years of age and older hospitalised with CAP at participating sites.
PCV13 efficacy for the prevention of vaccine-type community-acquired pneumonia (VT-CAP) and invasive pneumococcal disease (IPD) was established in the Community-acquired Pneumonia Immunization Trial in Adults (CAPITA) aged 65 and older. However, there are still few available real-life effectiveness estimates in adults. The aim of this study is to evaluate the PCV13 vaccine effectiveness (VE) against hospitalised VT-pneumococcal CAP among adults aged ≥60 years in the Region of Madrid (Spain). Determination of the effectiveness of PCV13 to prevent hospitalised vaccine-type (VT)-pneumococcal CAP among adults aged ≥60 years in Madrid will be evaluated using a test-negative design study, overall and among immunocompetent persons only.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All participants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urine sample collection | Diagnostic Test | Serotype specific UAD (urinary antigen detection) test |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Categorized as Cases and Controls to Determine Vaccine Effectiveness (VE) of PCV13 Against Hospitalized VT CAP: Overall | Cases were participants with CAP with a valid urinary antigen detection (UAD) result in whom PCV13 serotypes were identified by any method. Controls were participants with CAP with a valid UAD result and without having PCV13 serotype. VE was calculated as 1 minus the odd ratio comparing the odds of having received PCV13 for cases and controls, multiplied by 100%. VE is reported as part of statistical data in this outcome measure. | Approximately 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Categorized as Cases and Controls to Determine Vaccine Effectiveness (VE) of PCV13 Against Hospitalized VT CAP By Time Since Vaccination: Overall | Cases were participants with CAP with a valid UAD result in whom PCV13 serotypes were identified by any method. Controls were participants with CAP with a valid UAD result and without having PCV13 serotype. VE was calculated as 1 minus the odd ratio comparing the odds of having received PCV13 for cases and controls, multiplied by 100%. Data is presented in this outcome by time since vaccination. VE is reported as part of statistical data in this outcome measure. |
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Inclusion Criteria:
Exclusion Criteria:
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Adults, aged 60 years and over, who are hospitalized with CAP in one of the study hospitals: Hospital Universitario de Móstoles, Hospital Universitario Fundación de Alcorcón, and Hospital Rey Juan Carlos de Móstoles.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitarios De Getafe | Getafe | Madrid | 28905 | Spain | ||
| Hospital Universitario Severo Ochoa |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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A total of 1821 participants were enrolled in this study and 51 participants did not meet inclusion/exclusion of the study. In this study, a) pandemic period included data from 12 March 2021 to 31 July 2022 when last relevant coronavirus disease 2019 (COVID-19) wave in target population (aged >=60 years) ended in Madrid; b) post-pandemic period included data from 01 August 2022 to 13 September 2023.
Participants were evaluated for effectiveness of 13-valent pneumococcal conjugate vaccine (PCV13) [received previously at least 30 days before hospitalization] in preventing vaccine-type (VT) pneumococcal hospitalized community acquired pneumonia (CAP) among adults aged greater than or equal to (>=) 60 years in Madrid in this observational study.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Eligible participants who were hospitalized with CAP in one of the study hospitals, their data were observed for effectiveness of PCV13 (received previously, not in this study) in this observational study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
The per-protocol population included all participants in all enrolled population who met all inclusion/exclusion criteria.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Eligible participants who were hospitalized with CAP in one of the study hospitals, their data were observed for effectiveness of PCV13 (received previously, not in this study) in this observational study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Categorized as Cases and Controls to Determine Vaccine Effectiveness (VE) of PCV13 Against Hospitalized VT CAP: Overall | Cases were participants with CAP with a valid urinary antigen detection (UAD) result in whom PCV13 serotypes were identified by any method. Controls were participants with CAP with a valid UAD result and without having PCV13 serotype. VE was calculated as 1 minus the odd ratio comparing the odds of having received PCV13 for cases and controls, multiplied by 100%. VE is reported as part of statistical data in this outcome measure. | CAP UAD population included all enrolled population who met all inclusion/exclusion criteria and who had a final diagnosis consistent with CAP with a valid UAD result. | Posted | Count of Participants | Participants | Approximately 30 months |
|
Approximately 30 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | Eligible participants who were hospitalized with CAP in one of the study hospitals, their data were observed for effectiveness of PCV13 (received previously, not in this study) in this observational study. |
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A post-hoc SAP was developed to remove the COVID-19 pandemic period due to changes in healthcare-seeking behavior, hospital admission, vaccination policies, and CAP etiology that could have affected the validity of the overall results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer Clinical Trials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 3, 2022 | Oct 21, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 7, 2023 | Oct 21, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000098968 | Community-Acquired Pneumonia |
| ID | Term |
|---|---|
| D017714 | Community-Acquired Infections |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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| Saliva collection | Diagnostic Test | Streptococcus pneumonia identification in saliva samples by culture or PCR / RSV identification in saliva samples by PCR |
|
| Approximately 30 months |
| Percentage of CAP Participants Categorized Per Pneumococcal Serotypes Identified | Percentage of CAP participants in whom streptococcus pneumoniae was identified for PCV13 and 20-valent pneumococcal conjugate vaccine (PCV20) serotypes is reported. | Approximately 30 months |
| Percentage of CAP Participants in Whom Pneumococcus Identified From Saliva by Culture or Polymerase Chain Reaction (PCR) | Respiratory pneumococcal carriage was determined by testing saliva specimens using both conventional culture and the sensitive molecular method of PCR for the detection of two target genes (lytA and piaB). | Approximately 30 months |
| Percentage of CAP Participants With Underlying At-risk Medical Conditions | At-risk medical conditions included: alcoholism, asthma, celiac disease, chronic liver disease with hepatic failure, chronic liver disease without hepatic failure, chronic neurologic diseases, chronic obstructive pulmonary disease, coagulation factor replacement therapy, cochlear implant, congestive heart failure, coronary artery disease, cerebrospinal fluid leak, diabetes treated with medication, down syndrome, living in a nursing home, living in a long-term care facility, occupational risk with exposure to metal fumes, other chronic heart disease, other chronic lung disease, other pneumococcal disease risk factors, previous invasive pneumococcal disease, tobacco smoking (tobacco/e-cigarettes). | Approximately 30 months |
| Percentage of CAP Participants With Underlying at High-Risk Medical Conditions | High-risk medical conditions included: asplenia, cancer/malignancy (hematologic), cancer/malignancy (solid tumor), chronic kidney disease, human immunodeficiency virus (HIV) - acquired immunodeficiency syndrome (AIDS), HIV - No AIDS, immunodeficiency, immunosuppressant drug therapy, multiple myeloma, organ transplantation. | Approximately 30 months |
| Percentage of Streptococcus Pneumoniae (SP) Isolates With Antibiotic Resistance | Percentage of SP isolates with antibiotic resistance to penicillin, amoxicillin, cefotaxime, erythromycin, tetracycline, levofloxacin were reported in this outcome measure. | Approximately 30 months |
| Leganés |
| Madrid |
| 28911 |
| Spain |
| Hospital Universitario Fundación Alcorcón | Alcorcón | 28922 | Spain |
| Hospital Universitario Rey Juan carlos | Móstoles | 28933 | Spain |
| Hospital Universitario de Mostoles | Móstoles | 28935 | Spain |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
|
| Secondary | Number of Participants Categorized as Cases and Controls to Determine Vaccine Effectiveness (VE) of PCV13 Against Hospitalized VT CAP By Time Since Vaccination: Overall | Cases were participants with CAP with a valid UAD result in whom PCV13 serotypes were identified by any method. Controls were participants with CAP with a valid UAD result and without having PCV13 serotype. VE was calculated as 1 minus the odd ratio comparing the odds of having received PCV13 for cases and controls, multiplied by 100%. Data is presented in this outcome by time since vaccination. VE is reported as part of statistical data in this outcome measure. | CAP UAD population included all enrolled population who met all inclusion/exclusion criteria and who had a final diagnosis consistent with CAP with a valid UAD result. Here, "Number Analyzed" signifies participants who were evaluable for each category. | Posted | Count of Participants | Participants | Approximately 30 months |
|
|
|
|
| Secondary | Percentage of CAP Participants Categorized Per Pneumococcal Serotypes Identified | Percentage of CAP participants in whom streptococcus pneumoniae was identified for PCV13 and 20-valent pneumococcal conjugate vaccine (PCV20) serotypes is reported. | CAP UAD population included all enrolled population who met all inclusion/exclusion criteria and who had a final diagnosis consistent with CAP with a valid UAD result. | Posted | Number | 95% Confidence Interval | Percentage of CAP participants | Approximately 30 months |
|
|
|
| Secondary | Percentage of CAP Participants in Whom Pneumococcus Identified From Saliva by Culture or Polymerase Chain Reaction (PCR) | Respiratory pneumococcal carriage was determined by testing saliva specimens using both conventional culture and the sensitive molecular method of PCR for the detection of two target genes (lytA and piaB). | CAP UAD population included all enrolled population who met all inclusion/exclusion criteria and who had a final diagnosis consistent with CAP with a valid UAD result. Here, "Number of Participants Analyzed" signifies participants who had a valid saliva specimen test result. | Posted | Number | 95% Confidence Interval | Percentage of CAP participants | Approximately 30 months |
|
|
|
| Secondary | Percentage of CAP Participants With Underlying At-risk Medical Conditions | At-risk medical conditions included: alcoholism, asthma, celiac disease, chronic liver disease with hepatic failure, chronic liver disease without hepatic failure, chronic neurologic diseases, chronic obstructive pulmonary disease, coagulation factor replacement therapy, cochlear implant, congestive heart failure, coronary artery disease, cerebrospinal fluid leak, diabetes treated with medication, down syndrome, living in a nursing home, living in a long-term care facility, occupational risk with exposure to metal fumes, other chronic heart disease, other chronic lung disease, other pneumococcal disease risk factors, previous invasive pneumococcal disease, tobacco smoking (tobacco/e-cigarettes). | CAP UAD population included all enrolled population who met all inclusion/exclusion criteria and who had a final diagnosis consistent with CAP with a valid UAD result. | Posted | Number | Percentage of CAP participants | Approximately 30 months |
|
|
|
| Secondary | Percentage of CAP Participants With Underlying at High-Risk Medical Conditions | High-risk medical conditions included: asplenia, cancer/malignancy (hematologic), cancer/malignancy (solid tumor), chronic kidney disease, human immunodeficiency virus (HIV) - acquired immunodeficiency syndrome (AIDS), HIV - No AIDS, immunodeficiency, immunosuppressant drug therapy, multiple myeloma, organ transplantation. | CAP UAD population included all enrolled population who met all inclusion/exclusion criteria and who had a final diagnosis consistent with CAP with a valid UAD result. | Posted | Number | Percentage of CAP participants | Approximately 30 months |
|
|
|
| Secondary | Percentage of Streptococcus Pneumoniae (SP) Isolates With Antibiotic Resistance | Percentage of SP isolates with antibiotic resistance to penicillin, amoxicillin, cefotaxime, erythromycin, tetracycline, levofloxacin were reported in this outcome measure. | CAP UAD population included all enrolled population who met all inclusion/exclusion criteria and who had a final diagnosis consistent with CAP with a valid UAD result. Here, "Number of Participants Analyzed" = participants in CAP UAD population from whom valid SP isolates were obtained; "Number of SP isolates analyzed" = number of SP isolates with antimicrobial susceptibility tests performed. Only isolates with antimicrobial susceptibility tests performed were included in analysis. | Posted | Number | Percentage of SP isolates | Approximately 30 months | SP isolates | SP isolates |
|
|
|
| Post-Hoc | Number of Participants Categorized as Cases and Controls to Determine VE of PCV13 Against Hospitalized VT CAP: Post-Pandemic Period | Cases were participants with CAP with a valid UAD result in whom PCV13 serotypes were identified by any method. Controls were participants with CAP with a valid UAD result and without having PCV13 serotype. VE was calculated as 1 minus the odd ratio comparing the odds of having received PCV13 for cases and controls, multiplied by 100%. VE is reported as part of statistical data in this outcome measure. | CAP UAD population included all enrolled population who met all inclusion/exclusion criteria and who had a final diagnosis consistent with CAP with a valid UAD result. Here, "Number of Participants Analyzed" signifies participants in CAP UAD population for post-pandemic period. | Posted | Count of Participants | Participants | Approximately 13.5 months |
|
|
|
|
| Post-Hoc | Number of Participants Categorized as Cases and Controls to Determine Vaccine Effectiveness (VE) of PCV13 Against Hospitalized VT CAP By Time Since Vaccination: Post-pandemic Period | Cases were participants with CAP with a valid UAD result in whom PCV13 serotypes were identified by any method. Controls were participants with CAP with a valid UAD result and without having PCV13 serotype. VE was calculated as 1 minus the odd ratio comparing the odds of having received PCV13 for cases and controls, multiplied by 100%. Data is presented in this outcome by time since vaccination. VE is reported as part of statistical data in this outcome measure. | CAP UAD population included all enrolled population who met all inclusion/exclusion criteria and who had a final diagnosis consistent with CAP with a valid UAD result. Here, "Number of Participants Analyzed" signifies participants in CAP UAD population for post-pandemic period and "Number Analyzed" signifies participants who were evaluable for each category. | Posted | Count of Participants | Participants | Approximately 13.5 months |
|
|
|
|
| 198 |
| 1,680 |
| 0 |
| 1,680 |
| 0 |
| 1,680 |
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D012140 |
| Respiratory Tract Diseases |
| Received PCV13 in 2-<5 years or not received PCV13 |
|
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| Received PCV13 in >=5 years or not received PCV13 |
|
|
| Wald Test |
| 0.8367 |
| Adjusted VE |
| 4.72 |
| 2-Sided |
| 95 |
| -50.96 |
| 39.87 |
Adjusted for the covariates age group, weekly exposure to children less than 5 years, calendar time, and CAP with RSV infection. |
| Other |
| >=5 years | Wald Test | 0.7469 | Adjusted VE | 12.02 | 2-Sided | 95 | -91.53 | 59.59 | Adjusted for the covariates age group, weekly exposure to children less than 5 years, calendar time, and CAP with RSV infection. | Other |
| Title | Measurements |
|---|---|
|
| Erythromycin |
|
| Tetracycline |
|
| Levofloxacin |
|
| Received PCV13 in 2-<5 years or not received PCV13 |
|
|
| Received PCV13 in >=5 years or not received PCV13 |
|
|
| Wald Test |
| 0.738 |
| Adjusted VE |
| 7.97 |
| 2-Sided |
| 95 |
| -49.73 |
| 43.43 |
Adjusted for the covariates age group, weekly exposure to children less than 5 years, calendar time, and CAP with RSV infection. |
| Other |
| >=5 years | Wald Test | 0.4327 | Adjusted VE | 30.06 | 2-Sided | 95 | -70.86 | 71.37 | Adjusted for the covariates age group, weekly exposure to children less than 5 years, calendar time, and CAP with RSV infection. | Other |