Clinical trial · Observational
Safety and Efficacy of Concurrent Administration of Influenza Vaccine in Patients Undergoing Anti-PD-1 Immunotherapy (Nivolumab, Pembrolizumab)
NCT03061955CI-TRIAL-00081322completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Influenza | — | UNRESOLVED | — |
| Influenza Virus Vaccine Adverse Reaction (Disorder) | — | UNRESOLVED | — |
| Malignancy | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| influenza vaccination | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Number of participants with confirmed influenza infection as assessed by influenza rapid antigen A and B testing, nose swab.
- timeFrame
- October 1st 2016 to March 31st 2017
- description
- participants with confirmed influenza infection as assessed by influenza rapid antigen A and B testing, nose swab.
Secondary outcomes (3)
- measure
- Number of participants with adverse events and grading of adverse event as measured by the adverse events toxicity scale.
- timeFrame
- October 1st 2016 to March 31st 2017
- description
- participants with adverse events
- measure
- Number of participants requiring hospitalizations for adverse events or influenza infection.
- timeFrame
- October 1st 2016 to March 31st 2017
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (9)
- BACKGROUNDKunisaki KM, Janoff EN. Influenza in immunosuppressed populations: a review of infection frequency, morbidity, mortality, and vaccine responses. Lancet Infect Dis. 2009 Aug;9(8):493-504. doi: 10.1016/S1473-3099(09)70175-6. PMID 19628174
- BACKGROUNDMariotti J, Spina F, Carniti C, Anselmi G, Lucini D, Vendramin A, Pregliasco F, Corradini P. Long-term patterns of humoral and cellular response after vaccination against influenza A (H1N1) in patients with hematologic malignancies. Eur J Haematol. 2012 Aug;89(2):111-9. doi: 10.1111/j.1600-0609.2012.01793.x. Epub 2012 May 31. PMID 22540245
- BACKGROUNDPollyea DA, Brown JM, Horning SJ. Utility of influenza vaccination for oncology patients. J Clin Oncol. 2010 May 10;28(14):2481-90. doi: 10.1200/JCO.2009.26.6908. Epub 2010 Apr 12. PMID 20385981
- BACKGROUNDPreventing Infections in Cancer Patients. 2015. (Accessed June 22, 2016, at https://www.cdc.gov/cancer/flu/.)
- BACKGROUNDRousseau B, Loulergue P, Mir O, Krivine A, Kotti S, Viel E, Simon T, de Gramont A, Goldwasser F, Launay O, Tournigand C. Immunogenicity and safety of the influenza A H1N1v 2009 vaccine in cancer patients treated with cytotoxic chemotherapy and/or targeted therapy: the VACANCE study. Ann Oncol. 2012 Feb;23(2):450-7. doi: 10.1093/annonc/mdr141. Epub 2011 May 16. PMID 21576285
- BACKGROUNDMulder SF, Jacobs JF, Olde Nordkamp MA, Galama JM, Desar IM, Torensma R, Teerenstra S, Mulders PF, Vissers KC, Punt CJ, de Vries IJ, van Herpen CM. Cancer patients treated with sunitinib or sorafenib have sufficient antibody and cellular immune responses to warrant influenza vaccination. Clin Cancer Res. 2011 Jul 1;17(13):4541-9. doi: 10.1158/1078-0432.CCR-11-0253. Epub 2011 Jun 28. PMID 21712444
- BACKGROUNDMonkman K, Mahony J, Lazo-Langner A, Chin-Yee BH, Minuk LA. The pandemic H1N1 influenza vaccine results in low rates of seroconversion for patients with hematological malignancies. Leuk Lymphoma. 2011 Sep;52(9):1736-41. doi: 10.3109/10428194.2011.584003. Epub 2011 Jun 12.