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

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

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

Study Overview

• Status: Completed
• Conditions: Community Acquired Pneumonia (CAP)
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 1786

Contacts and Locations

Study Locations

• Spain
  • Alcorcón, Madrid, Spain, 28922
    • Hospital Universitario Fundacion Alcorcon
  • Mostoles, Spain, 28935
    • Hospital Universitario de Móstoles / Servicio de Oncología Médica
  • Móstoles, Spain, 28933
    • Hospital Universitario Rey Juan carlos
  • Madrid
    • Getafe, Madrid, Spain, 28905
      • Hospital Universitarios De Getafe
    • Leganés, Madrid, Spain, 28911
      • Hospital Universitario Severo Ochoa
    • Mostoles, Madrid, Spain, 28935
      • Hospital Universitario de Mostoles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaccine effectiveness (VE)	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.	4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	4 years
Proportion of persons with respiratory pneumococcal carriage among adults 60 years of age and older presenting with CAP	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.	4 years
Proportion of participants with CAP and SP-CAP with underlying medical conditions	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 years
Frequency of antibiotic resistance among Streptococcus pneumoniae isolates by type	Proportion of S. pneumoniae isolates with antibiotic resistance identified by standard of care testing, overall and by resistance type	4 years

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2021
• Primary Completion (Actual): October 25, 2023
• Study Completion (Actual): March 24, 2024

Study Registration Dates

• First Submitted: October 19, 2020
• First Submitted That Met QC Criteria: November 2, 2020
• First Posted (Actual): November 3, 2020

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: B1851202; CIBELES (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No