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

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

Completed

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Key information

Conditions

Cancer Cardiomyopathies Cardiovascular Diseases Heart Diseases Infections Influenza, Human Muscular Diseases Musculoskeletal Diseases Myocarditis Myositis Neoplasms Nervous System Diseases Neuromuscular Diseases Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Rhabdomyolysis Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Princeton, New Jersey, 08540, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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/exclusion criteria could apply

Treatment and study plan

Non-Interventional

Other

Non-Interventional

Primary outcomes

Incidence of myocarditis

Time frame: Approximately 7 years
Incidence of myositis

Time frame: Approximately 7 years
Incidence of rhabdomyolysis

Time frame: Approximately 7 years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2018
First posted: Aug 23, 2018
Registry last updated: Jan 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed