Study to Determine if the Flu Vaccine Increases the Risk of Muscle Damage in Participants Taking Drugs That Block Certain Proteins Made by Some Types of Immune System Cells

Risk of Muscle Damage in Cancer Patients Exposed to the Influenza Vaccine While Receiving Checkpoint Inhibitor Therapies: A Nested Case Control Study Using Claims Data

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03644498

Enrollment

1056

Registered

2018-08-23

Start date

2018-05-02

Completion date

2018-10-17

Last updated

2024-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

influenza, myositis, myocarditis, rhabdomyolysis, checkpoint inhibitors

Brief summary

A retrospective, observational study conducted on cancer patients receiving a drug that blocks certain proteins made by some types of immune system cells

Interventions

OTHERNon-Interventional

Non-Interventional

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Treatment with a checkpoint inhibitor (CPI) * Age greater than or equal to 18 years on date of first claim for a CPI * ICD-9 or ICD-10 code for a malignancy within 180 days prior to the first claim for any CPI, and * Greater than or equal to 180 days of continuous pharmaceutical and medical benefit enrollment in the database prior to the first claim for any CPI

Exclusion criteria

* Less than 18 years of age Other protocol defined inclusion/

Design outcomes

Primary

Measure	Time frame
Incidence of myocarditis	Approximately 7 years
Incidence of myositis	Approximately 7 years
Incidence of rhabdomyolysis	Approximately 7 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026