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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1821 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-12

Study Completion Date

2024-03-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effectiveness of the PCV13 in Older Thai Adults

NCT06279624

Community-acquired Pneumonia

COMPLETED

Safety and Efficacy Study of Investigational Pneumococcal Vaccine in Elderly Population

NCT00307528

Prophylaxis Invasive Pneumococcal Diseases and Pneumonia

COMPLETED PHASE2

Study Evaluating The Safety, Tolerability And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)

NCT00546572

Pneumococcal Infections

COMPLETED PHASE3

20-valent Pneumococcal Conjugate Vaccine Safety Study in Healthy Infants

NCT04379713

Pneumococcal Disease

COMPLETED PHASE3

Safety and Immunogenicity Study of 20vPnC in Healthy Children 15 Months Through 17 Years of Age

NCT04642079

Pneumococcal Disease

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Community Acquired Pneumonia (CAP)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

All participants

Urine sample collection

Intervention Type DIAGNOSTIC_TEST

Serotype specific UAD (urinary antigen detection) test

Saliva collection

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Urine sample collection

Serotype specific UAD (urinary antigen detection) test

Intervention Type DIAGNOSTIC_TEST

Saliva collection

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No