FractureNCT07231016
Influenza Vaccination Against Infectious Complications and Mortality in Older Adults With Fractures: a Large-scale Retrospective Cohort Study
An observational study of Fracture and Influenza Vaccination, run by Taipei Medical University Hospital at 1 site in Taiwan.
Trial summary
Background: Both influenza and bone fractures are significant contributors to morbidity and mortality among older adults. This study evaluated the associations between influenza vaccination (IV) and adverse outcomes following fracture-related hospitalizations in elderly individuals. Read more about this study
- Who is it for?
- Ages 20 days and olderHealthy volunteers can take part
- Conditions the study is for
- Fracture, Influenza Vaccination
- How many people
- 561,566 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2019to 1 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 20 days and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: This study utilized a nationwide, population-based cohort encompassing over twenty million insured individuals. From this cohort, we identified older adults admitted for fracture treatment between 2009 and 2020. Among them, approximately two in five had received an influenza vaccination within the year before hospitalization. To minimize confounding, we performed one-to-one propensity score matching, pairing each vaccinated patient with an unvaccinated counterpart based on demographic, socioeconomic, and clinical characteristics, including age, sex, income status, fracture type, comorbidities, and prior healthcare utilization.
Who may be able to join
- Patients with fracture hospitalization who aged more than 65 years
Who cannot join
- People had no fracture hospitalization and people aged lower than 65 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Protective Effect of Influenza Vaccine for Vulnerable Population
Background: Both influenza and bone fractures are significant contributors to morbidity and mortality among older adults. This study evaluated the associations between influenza vaccination (IV) and adverse outcomes following fracture-related hospitalizations in elderly individuals.
Methods: A retrospective cohort study was conducted utilizing data from a health insurance database in Taiwan. The study included 561,566 individuals aged 65 years and older who were hospitalized for fractures between 2009 and 2020. Patients were stratified according to whether they had received an IV within the 12 months preceding their fracture event. Propensity score matching was employed between the vaccinated and unvaccinated groups. Multivariate logistic regression models were used to estimate adjusted odds ratios (ORs) and 95% confidence intervals (CIs) for postfracture infectious complications and 30-day mortality associated with prior IV.
Read the detailed description
A nested retrospective cohort design was adopted to evaluate the influence of IVs on clinical outcomes following fracture-related hospitalizations. The analysis drew upon a nationwide, dynamic cohort comprising more than 23 million insured individuals. From this population, we identified 561,566 patients aged 65 years and older who were admitted for fracture treatment between 2009 and 2020. Among them, 213,381 individuals had received an IV within the 12 months prior to admission, whereas 348,185 had not.
To mitigate potential confounding, we applied 1:1 propensity score matching, pairing each vaccinated patient with a nonvaccinated counterpart. The matching criteria included demographic characteristics (age, sex), socioeconomic status (low-income designation), fracture type, comorbidities (documented within the previous 24 months), emergency department visits, and hospital admissions during the 12 months preceding the fracture event.
The primary outcomes were assessed within 30 days postadmission and included the occurrence of pneumonia, septicemia, urinary tract infections, intensive care, hospital length of stay, total medical expenditure, and 30-day mortality. Postfracture infectious complications were identified through physician-coded diagnoses during the index hospitalization or in subsequent inpatient and outpatient claims within 30 days. To avoid confounding due to preexisting infections, individuals with documented cases of pneumonia or septicemia within the six months before fractures were excluded from the analysis.
- Conditions
- Fracture, Influenza Vaccination
- Keywords
- Influenza vaccination, infectious diseases, mortality, fracture
- Medical subject headings
- Fractures, Bone, Influenza, Human, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with fracture hospitalization | A retrospective cohort study was conducted utilizing data from a health insurance database in Taiwan. The study included 561,566 individuals aged 65 years and older who were hospitalized for fractures between 2009 and 2020. |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-fracture 30-day mortality
We calculated the mortality after fracture hospitalization within 30-day period.
Measured: 30-day period after fracture hospitalization
mortality after fracture
30-day mortality after fracture hospitalization
Measured: 30-day period after fracture hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start1 Nov 2019
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FractureStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 561,566 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chien-Chang Liao, PhD, MPH, Principal investigator, Taipei Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07231016
- Sponsor's protocol ID
- TMU-JIRB-201910032
- Other IDs
- TMU-Joint Institutional Review
- Status last verified
- Oct 2019
- First submitted
- 13 Nov 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Protective Effect of Influenza Vaccine for Vulnerable Population
- ClinicalTrials.gov ID
- NCT07231016
- Acronym / sponsor ID
- TMU-JIRB-201910032
- Conditions
- Fracture, Influenza Vaccination
- Keywords
- Influenza vaccination, infectious diseases, mortality, fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 561,566 participants (actual)
- Lead sponsor
- Taipei Medical University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 17 Nov 2025 (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.
Background: Both influenza and bone fractures are significant contributors to morbidity and mortality among older adults. This study evaluated the associations between influenza vaccination (IV) and adverse outcomes following fracture-related hospitalizations in elderly individuals.
Methods: A retrospective cohort study was conducted utilizing data from a health insurance database in Taiwan. The study included 561,566 individuals aged 65 years and older who were hospitalized for fractures between 2009 and 2020. Patients were stratified according to whether they had received an IV within the 12 months preceding their fracture event. Propensity score matching was employed between the vaccinated and unvaccinated groups. Multivariate logistic regression models were used to estimate adjusted odds ratios (ORs) and 95% confidence intervals (CIs) for postfracture infectious complications and 30-day mortality associated with prior IV.
Detailed description
A nested retrospective cohort design was adopted to evaluate the influence of IVs on clinical outcomes following fracture-related hospitalizations. The analysis drew upon a nationwide, dynamic cohort comprising more than 23 million insured individuals. From this population, we identified 561,566 patients aged 65 years and older who were admitted for fracture treatment between 2009 and 2020. Among them, 213,381 individuals had received an IV within the 12 months prior to admission, whereas 348,185 had not.
To mitigate potential confounding, we applied 1:1 propensity score matching, pairing each vaccinated patient with a nonvaccinated counterpart. The matching criteria included demographic characteristics (age, sex), socioeconomic status (low-income designation), fracture type, comorbidities (documented within the previous 24 months), emergency department visits, and hospital admissions during the 12 months preceding the fracture event.
The primary outcomes were assessed within 30 days postadmission and included the occurrence of pneumonia, septicemia, urinary tract infections, intensive care, hospital length of stay, total medical expenditure, and 30-day mortality. Postfracture infectious complications were identified through physician-coded diagnoses during the index hospitalization or in subsequent inpatient and outpatient claims within 30 days. To avoid confounding due to preexisting infections, individuals with documented cases of pneumonia or septicemia within the six months before fractures were excluded from the analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with fracture hospitalization | – | –A retrospective cohort study was conducted utilizing data from a health insurance database in Taiwan. The study included 561,566 individuals aged 65 years and older who were hospitalized for fractures between 2009 and 2020. |
Who may qualify
- Ages
- 20 days and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study utilized a nationwide, population-based cohort encompassing over twenty million insured individuals. From this cohort, we identified older adults admitted for fracture treatment between 2009 and 2020. Among them, approximately two in five had received an influenza vaccination within the year before hospitalization. To minimize confounding, we performed one-to-one propensity score matching, pairing each vaccinated patient with an unvaccinated counterpart based on demographic, socioeconomic, and clinical characteristics, including age, sex, income status, fracture type, comorbidities, and prior healthcare utilization.
Key inclusion criteria (1 listed)
- Patients with fracture hospitalization who aged more than 65 years
Key exclusion criteria (1 listed)
- People had no fracture hospitalization and people aged lower than 65 years
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
post-fracture 30-day mortality
Time frame: 30-day period after fracture hospitalization
We calculated the mortality after fracture hospitalization within 30-day period.
mortality after fracture
Time frame: 30-day period after fracture hospitalization
30-day mortality after fracture hospitalization
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 17 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Chien-Chang Liao, PhD, MPH principal investigator
Taipei Medical University Hospital
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 Fracture and Influenza Vaccination, run by Taipei Medical University Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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 17 Nov 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 Taiwan. 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?
post-fracture 30-day mortality (time frame: 30-day period after fracture hospitalization). The study lists 2 primary outcomes in all. 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 17 Nov 2025.