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

NCT04613375 | Completed Results

• 2 other identifiers: B1851202CIBELES
• Study Type: observational
• Target: 1,821
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Community Acquired Pneumonia (CAP)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Number of Participants Categorized as Cases and Controls to Determine Vaccine Effectiveness (VE) of PCV13 Against Hospitalized VT CAP By Time Since Vaccination: Overall

  Approximately 30 months

• Percentage of CAP Participants Categorized Per Pneumococcal Serotypes Identified

  Approximately 30 months

• Percentage of CAP Participants in Whom Pneumococcus Identified From Saliva by Culture or Polymerase Chain Reaction (PCR)

  Approximately 30 months

• Percentage of CAP Participants With Underlying At-risk Medical Conditions

  Approximately 30 months

• Percentage of CAP Participants With Underlying at High-Risk Medical Conditions

  Approximately 30 months

Study Arms (1)

All participants

Diagnostic Test: Urine sample collection; Diagnostic Test: Saliva collection

Interventions

Urine sample collection DIAGNOSTIC_TEST

Serotype specific UAD (urinary antigen detection) test

All participants

Saliva collection DIAGNOSTIC_TEST

Streptococcus pneumonia identification in saliva samples by culture or PCR / RSV identification in saliva samples by PCR

All participants

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age ≥60 years.
• Evidence of pneumonia within first 48 hours of hospital admission
• 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.

You may not qualify if:

• 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).
• Previously enrolled subjects readmitted ≤14 days after discharge for their study qualifying admission.
• At the time of enrollment, pneumonia has been excluded as the diagnosis or another diagnosis confirmed.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (5)

Hospital Universitarios De Getafe

Getafe, Madrid, 28905, Spain

Location

Hospital Universitario Severo Ochoa

Leganés, Madrid, 28911, Spain

Location

Hospital Universitario Fundación Alcorcón

Alcorcón, 28922, Spain

Location

Hospital Universitario Rey Juan carlos

Móstoles, 28933, Spain

Location

Hospital Universitario de Mostoles

Móstoles, 28935, Spain

Location

Related Links

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

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Pfizer Clinical Trials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: November 3, 2020
• Study Start: March 12, 2021
• Primary Completion: October 25, 2023
• Study Completion: March 24, 2024
• Last Updated: June 11, 2025
• Results First Posted: January 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (5)