Effectiveness of the PCV13 in Older Thai Adults

NCT06279624 | Completed

• 1 other identifier: NRCT9-4
• Study Type: observational
• Target: 825
• Locations: 1 country
• Sites: 1

Brief Summary

This is the matched 1:2 case-control study, prospectively collect case and control who are diagnosed with pneumococcal or non-pneumococcal community acquired pneumonia (CAP), accordingly from November 2023 through October 2024. The investigators define a CASE as a person aged ≥60 years due to pneumococcal confirmed CAP either in-patients or out-patients by doctor in charge. While a CONTROL is defined as a person aged ≥60 years due to non-pneumococcal confirmed CAP either in-patients or out-patients by doctor in charge. The goal of this observational study is to evaluate the effectiveness of the 13-valent pneumococcal conjugate vaccine (PCV13) in pneumococcal CAP in Thai adults aged ≥ 60 years with or without any medical conditions. The main questions it aims to answer is:

• What are the effectiveness of PCV13 for preventing all typed, vaccine typed, or non-vaccine typed of pneumococcal CAP among Thai older adults? The investigators retrospectively collect cases and control who are diagnosed with CAP accordingly from January 2012 through October 2023. The investigators define case and control the same as prospective method, but all data were retrieved from archive database.
• The investigators select a 1:2 matched control with criteria as follows; 10-year-interval of age, ward (the same patient care such as out or in-patient, or admitted in the same level ward). Participants will be
• collated from hospital database regarding their CAP illnesses by pneumococcal and non-pneumococcal pneumonia condition.
• explored their vaccine status by either vaccine book checking or hospital database. Researcher will compare the effectiveness of PCV13 to prevent all typed, vaccine typed and non-vaccine typed pneumococcal pneumonia.

Conditions

Community-acquired Pneumonia

Outcome Measures

Primary Outcomes (1)

• Vaccine effectiveness of PCV13 on all types of pneumococcal CAP

  All types of pneumococcal CAP will be determined by the total number of confirmed pneumococcal CAP cases regardless of serotypes over study period (unit: number of cases). Then, CAP cases will be stratified by history of vaccine. Vaccine effectiveness (VE) is calculated as follows; VE = 1- OR. OR (odds ratio) define as pneumococcal confirmed CAP among PCV13 vaccinated group/ pneumococcal confirmed CAP among without PCV13 vaccinated group.

  April - June 2025

Secondary Outcomes (1)

• Vaccine effectiveness of PCV13 on PCV13 (vaccine typed) and non-PCV13 (non-vaccine typed) pneumococcal CAP

  April - June 2025

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Thai older adults aged ≥60 years with or without health conditions 2. Diagnosed with all caused community acquired pneumonia by doctor in-charge. 3. Either in-hospital admission or out-patient care 4. Confirmed PCV13 vaccine history documented by verbal or vaccination record.

You may qualify if:

• Prospective collection For case
• Thai older adults aged ≥60 years with or without health conditions diagnosed with culture confirmed pneumococcal community acquired pneumonia during 2012 - 2024.
• Be given treatment either in-hospital admission or out-patient visiting hospital.
• They ensure their PCV13 status (either received or not received is acceptable)
• Willing to participate in the study by their own decision or as a legal guardian.
• For matched control
• Thai older adults aged ≥60 years with or without health conditions diagnosed with non-pneumococcal community acquired pneumonia by doctor in-charge during 2012 - 2024.
• Be given treatment either in-hospital admission or out-patient visiting in the same hospital with matched-case.
• They ensure their PCV13 status (either received or not received is acceptable)
• Willing to participate in the study by their own decision or as a legal guardian.
• Retrospective collection For case
• Thai older adults aged ≥60 years with or without health conditions diagnosed with culture confirmed pneumococcal community acquired pneumonia during 2012 - 2024.
• Be given treatment either in-hospital admission or out-patient visiting hospital.
• Certain documented PCV13 status (either received or not received is acceptable)
• Recorded ICD: J13

You may not qualify if:

• For case
• Unknown PCV13 status/history
• Timing between PCV13 and the onset of community acquired pneumonia \<14 days.
• Unable to collect confirmed pneumococcal samples from microbiology laboratory.
• For control
• Unknown PCV13 status/history
• Timing between PCV13 and the onset of community acquired pneumonia \<14 days.

Sponsors & Collaborators

• Mahidol University: lead
• National Research Council of Thailand: collaborator

Study Sites (1)

Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University

Bangkok, Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

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

Study Officials

• Punnee Pitisuttithum, Prof.

  Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: February 28, 2024
• Study Start: February 5, 2024
• Primary Completion: January 30, 2025
• Study Completion: January 30, 2025
• Last Updated: May 9, 2025

Record last verified: 2025-05

Locations

TH (1)