NCT07231016

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
561,566

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 17, 2025

Completed
Last Updated

November 17, 2025

Status Verified

October 1, 2019

Enrollment Period

5.2 years

First QC Date

November 13, 2025

Last Update Submit

November 13, 2025

Conditions

Keywords

Influenza vaccinationinfectious diseasesmortalityfracture

Outcome Measures

Primary Outcomes (2)

  • post-fracture 30-day mortality

    We calculated the mortality after fracture hospitalization within 30-day period.

    30-day period after fracture hospitalization

  • mortality after fracture

    30-day mortality after fracture hospitalization

    30-day period after fracture hospitalization

Study Arms (1)

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.

Eligibility Criteria

Age20 Days+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • Patients with fracture hospitalization who aged more than 65 years

You may not qualify if:

  • People had no fracture hospitalization and people aged lower than 65 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University Hospital

Taipei, 110, Taiwan

Location

MeSH Terms

Conditions

Fractures, BoneInfluenza, HumanCommunicable Diseases

Condition Hierarchy (Ancestors)

Wounds and InjuriesRespiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Chien-Chang Liao, PhD, MPH

    Taipei Medical University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2025

First Posted

November 17, 2025

Study Start

November 1, 2019

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

November 17, 2025

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations