Community-acquired PneumoniaNCT06279624
Effectiveness of the PCV13 in Older Thai Adults
An observational study of Community-acquired Pneumonia, run by Mahidol University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Community-acquired Pneumonia
- How many people
- 825 participants
- Where
- 1 siteThailand
- Study dates
- 5 Feb 2024to 30 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 20Show fewer
- 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
- 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.
- Certain documented PCV13 status (either received or not received is acceptable)
- Recorded ICD: J09-18 (except J13)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University
Bangkok, Bangkok, 10400
About this study
Official title: Effectiveness of the 13-Valent Pneumococcal Conjugated Vaccine Against Community-Acquired Pneumonia in Older Thai Adults: A Matched Case-Control Study.
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.
Read more
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.
Read the detailed description
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).
Patient data will be collected through review of medical records and interview of the patients or their relatives for visits to the doctors using standard Case Record Form (CRF) by trained research assistance.
Definition of CAP is defined according to clinical evidence and radiological evidence17. The clinical evidence consists of ≥2 of the following: fever, hypothermia, chills or rigors, pleuritic chest pain, cough, sputum production, dyspnea, tachypnea, malaise, or abnormal auscultatory findings suggestive of pneumonia; while the radiological evidence includes a chest radiograph and/or a computed tomographic image with an infiltrate consistent with pneumonia as determined by the treating healthcare provider or radiologist at the time of presentation. The investigators consider PCV13 status when the vaccine has been given ≥14 days before onset of CAP for cases or ≥14 days before the date of admission for control. The PCV13 status is ascertained by staff blinded to whether the patients are case or control. Status will be confirmed by hospital record or vaccination card. If history of vaccination is verbal confirmation by patient or their relatives, then the investigators plan to figure vaccine status out in all hospitals that individuals has visited before admission.
- Conditions
- Community-acquired Pneumonia
- Medical subject headings
- Community-Acquired Pneumonia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: April - June 2025
Secondary outcomes (1)
Vaccine effectiveness of PCV13 on PCV13 (vaccine typed) and non-PCV13 (non-vaccine typed) pneumococcal CAP
Vaccine types of pneumococcal CAP will be measured by the number of confirmed pneumococcal CAP cases in which pneumococcal serotype identified in vaccine (PCV13) over study period (unit: number of cases). Non-vaccine types of pneumococcal CAP will be measured by the number of confirmed pneumococcal diagnosed CAP cases in which pneumococcal serotype unidentified in vaccine (PCV13) over study period (unit: number of cases). Vaccine effectiveness will be calculated the same way as primary outcome measurement.
Measured: April - June 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start5 Feb 2024
- Primary completion30 Jan 2025
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 825 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Council of Thailand
- Responsible party
- Sponsor
- Investigators
- Punnee Pitisuttithum, Prof., Study chair, Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06279624
- Sponsor's protocol ID
- NRCT9-4
- Status last verified
- May 2025
- First submitted
- 5 Jan 2024
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the 13-Valent Pneumococcal Conjugated Vaccine Against Community-Acquired Pneumonia in Older Thai Adults: A Matched Case-Control Study.
- ClinicalTrials.gov ID
- NCT06279624
- Acronym / sponsor ID
- NRCT9-4
- Conditions
- Community-acquired Pneumonia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 825 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- National Research Council of Thailand
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Patient data will be collected through review of medical records and interview of the patients or their relatives for visits to the doctors using standard Case Record Form (CRF) by trained research assistance.
Definition of CAP is defined according to clinical evidence and radiological evidence17. The clinical evidence consists of ≥2 of the following: fever, hypothermia, chills or rigors, pleuritic chest pain, cough, sputum production, dyspnea, tachypnea, malaise, or abnormal auscultatory findings suggestive of pneumonia; while the radiological evidence includes a chest radiograph and/or a computed tomographic image with an infiltrate consistent with pneumonia as determined by the treating healthcare provider or radiologist at the time of presentation. The investigators consider PCV13 status when the vaccine has been given ≥14 days before onset of CAP for cases or ≥14 days before the date of admission for control. The PCV13 status is ascertained by staff blinded to whether the patients are case or control. Status will be confirmed by hospital record or vaccination card. If history of vaccination is verbal confirmation by patient or their relatives, then the investigators plan to figure vaccine status out in all hospitals that individuals has visited before admission.
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (20 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Vaccine effectiveness of PCV13 on all types of pneumococcal CAP
Time frame: April - June 2025
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.
1 secondary outcome
Vaccine effectiveness of PCV13 on PCV13 (vaccine typed) and non-PCV13 (non-vaccine typed) pneumococcal CAP
Time frame: April - June 2025
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Punnee Pitisuttithum, Prof. study chair
Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Community-acquired Pneumonia, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaccine effectiveness of PCV13 on all types of pneumococcal CAP (time frame: April - June 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.