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PCV13 Effectiveness Study Against Hospitalised VT Pneumococcal CAP in Adults 60 Years and Older

Sponsor
Pfizer (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04613375
Collaborator
(none)
3,600
Enrollment
4
Locations
48
Anticipated Duration (Months)
900
Patients Per Site
18.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Low interventional, prospective, multicentre, hospital-based study involving adults 60 years of age and older hospitalised with CAP at participating sites.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Urine sample collection
  • Diagnostic Test: Saliva collection

Detailed Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
3600 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Low Intervention Study of the Effectiveness Of 13-Valent Pneumococcal Conjugate Vaccine (PCV13) Against Vaccine Type Pneumococcal Hospitalised Community Acquired Pneumonia (CAP) in Adults 60 Years and Older Using A Test Negative Design Study in A Well-Defined Area of the South of Madrid Region
Actual Study Start Date :
Mar 12, 2021
Anticipated Primary Completion Date :
Mar 11, 2025
Anticipated Study Completion Date :
Mar 11, 2025

Arms and Interventions

Arm Intervention/Treatment
All participants

Diagnostic Test: Urine sample collection
Serotype specific UAD (urinary antigen detection) test

Diagnostic Test: Saliva collection
Streptococcus pneumonia identification in saliva samples by culture or PCR / RSV identification in saliva samples by PCR

Outcome Measures

Primary Outcome Measures

  1. Vaccine effectiveness (VE) [4 years]

    VE calculated as 1 minus the OR* comparing the odds of having received PCV13 for cases and controls, multiplied by 100, overall and restricted to immunocompetent subjects only.

Secondary Outcome Measures

  1. Proportion of CAP events for each pneumococcal serotype, PCV-13, and 20-valent pneumococcal conjugate vaccine (PCV20) serotypes among all CAP subjects with UAD1/2 testing (overall) and among all CAP subjects with a pneumococcus identified [4 years]

    Distribution of S. pneumoniae serotypes using blood, high-quality respiratory cultures, and a serotype-specific urinary antigen detection (UAD) assay among adults 60 years of age and older with CAP.

  2. Proportion of persons with respiratory pneumococcal carriage among adults 60 years of age and older presenting with CAP [4 years]

    Proportion of CAP events where the pneumococcus was identified from saliva by the conventional culture or the sensitive molecular method of PCR divided by all CAP events where the subject had a valid saliva specimen test result.

  3. Proportion of participants with CAP and SP-CAP with underlying medical conditions [4 years]

    Proportion of CAP subjects with underlying at-risk and high-risk medical conditions, overall and restricted to those with pneumococcus isolated from blood, high-quality respiratory cultures, and a serotype specific urinary antigen detection (UAD) assay

  4. Frequency of antibiotic resistance among Streptococcus pneumoniae isolates by type [4 years]

    Proportion of S. pneumoniae isolates with antibiotic resistance identified by standard of care testing, overall and by resistance type

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Age ≥60 years.

  2. Evidence of pneumonia within first 48 hours of hospital admission

  3. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

  1. Any patient who develops signs and symptoms of pneumonia after being hospitalized for ≥48 hours (either at current hospital, another transferring hospital, or a combination of these).

  2. Previously enrolled subjects readmitted ≤14 days after discharge for their study qualifying admission.

  3. At the time of enrollment, pneumonia has been excluded as the diagnosis or another diagnosis confirmed.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Universitario de Móstoles / Servicio de Oncología Médica Móstoles Madrid Spain 28935
2 Hospital Universitario Fundación Alcorcón Alcorcón, Madrid Spain 28922
3 Hospital Universitario de Mostoles Mostoles Spain 28935
4 Hospital Universitario Rey Juan carlos Móstoles Spain 28933

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT04613375
Other Study ID Numbers:
  • B1851202
  • CIBELES
First Posted:
Nov 3, 2020
Last Update Posted:
Jul 25, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Pneumonia

Study Results

No Results Posted as of Jul 25, 2022