Safety and Efficacy of Concurrent Administration of Influenza Vaccine in Patients Undergoing Anti… (NCT03061955) | Clinical Trial Compass
CompletedNot Applicable
Safety and Efficacy of Concurrent Administration of Influenza Vaccine in Patients Undergoing Anti-PD-1 Immunotherapy (Nivolumab, Pembrolizumab)
28 participantsStarted 2016-10-01
Plain-language summary
The objective of this study is to evaluate the safety and efficacy of concurrent administration of influenza vaccine in patients receiving anti-PD1 immunotherapy (nivolumab or pembrolizumab). This will be a prospective observational study, aiming to assess patient tolerance of treatment, adverse events (incidence, grade, need for hospitalization), incidence of influenza infections, and seroconversion rates.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18 years or older
* Currently receiving immunotherapy with anti-PD-1 agents (Nivolumab or Pembrolizumab)
* Have not received influenza vaccination prior to study entry date for the upcoming flu season 2016-2017
* No previous contraindication to receiving influenza vaccination
* Histologically proven cancer
* Expected lifetime of at least 12 weeks
Exclusion Criteria:
* Previous cancer
* Autoimmune disease or immunosuppressive treatments
* Corticosteroid treatment
* Those who have a potential indication to change chemotherapy treatment in 42 days following start of treatment
* History of clinically or virologically confirmed influenza infection in the previous six months
* Previous contraindication to receiving influenza vaccination
* Previous allergic/adverse reaction with influenza vaccination
* Have received influenza vaccination prior to study entry date for upcoming 2016-2017 flu season
* Positive anti influenza antibody titers as determined by the baseline blood determination (day 0)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with confirmed influenza infection as assessed by influenza rapid antigen A and B testing, nose swab.