Clinical trial · Interventional
Evaluation of Influenza H1N1 Vaccine in Adults With Lymphoid Malignancies on Chemotherapy
Evaluation of Pandemic H1N1(2009) Influenza Vaccine in Adults With Lymphoid Malignancies on Active Systemic Treatment or Post Stem Cell Transplantation
NCT01016548CI-TRIAL-00003516completedPhase 3ClinicalTrials.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 purpose of this study is to determine whether adults with hematologic malignancies on active systemic therapy or shortly after bone marrow transplantation need one or two doses of adjuvanted vaccine to achieve best possible rates of protection. An additional research question is whether baseline biomarkers of the cellular and humoral immune systems are associated with an antibody response to vaccination.
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 A Virus, H1N1 Subtype | — | UNRESOLVED | — |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AS03-adjuvanted H1N1 pandemic influenza vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Two doses of vaccine
- description
- Second dose is given 21 days after the initial dose. The same dose and route of administration are used.
- interventionNames
- Biological: AS03-adjuvanted H1N1 pandemic influenza vaccine
- type
- ACTIVE_COMPARATOR
- label
- One dose of vaccine
- description
- Given at baseline only.
- interventionNames
- Biological: AS03-adjuvanted H1N1 pandemic influenza vaccine
Primary outcomes (1)
- measure
- Seroconversion rates.
- timeFrame
- Day 0, 21, 42
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female, ages 20-65 * Diagnosis of lymphoproliferative disorder * One of the following types of systemic treatment: active chemo/immunotherapy at enrollment or completed within the last 3 months, OR auto/allo stem cell transplant recipient within the past 12 months * Able to provide consent and comply with trial requirements Exclusion Criteria: * Systemic hypersensitivity to hen's eggs, thimerosal, gentamicin * History of life-threatening reaction to prior influenza vaccination * Thrombocytopenia or bleeding disorder contraindicating IM injection * Pregnancy * Laboratory-confirmed infection with H1N1(2009) * IVIG infusion within the last three months
References
Publications (6)
- BACKGROUNDCarter NJ, Plosker GL. Prepandemic influenza vaccine H5N1 (split virion, inactivated, adjuvanted) [Prepandrix]: a review of its use as an active immunization against influenza A subtype H5N1 virus. BioDrugs. 2008;22(5):279-92. doi: 10.2165/00063030-200822050-00001. PMID 18778110
- BACKGROUNDGreenberg ME, Lai MH, Hartel GF, Wichems CH, Gittleson C, Bennet J, Dawson G, Hu W, Leggio C, Washington D, Basser RL. Response to a monovalent 2009 influenza A (H1N1) vaccine. N Engl J Med. 2009 Dec 17;361(25):2405-13. doi: 10.1056/NEJMoa0907413. Epub 2009 Sep 10. PMID 19745216
- BACKGROUNDClark TW, Pareek M, Hoschler K, Dillon H, Nicholson KG, Groth N, Stephenson I. Trial of 2009 influenza A (H1N1) monovalent MF59-adjuvanted vaccine. N Engl J Med. 2009 Dec 17;361(25):2424-35. doi: 10.1056/NEJMoa0907650. Epub 2009 Sep 10. PMID 19745215
- BACKGROUNDZhu FC, Wang H, Fang HH, Yang JG, Lin XJ, Liang XF, Zhang XF, Pan HX, Meng FY, Hu YM, Liu WD, Li CG, Li W, Zhang X, Hu JM, Peng WB, Yang BP, Xi P, Wang HQ, Zheng JS. A novel influenza A (H1N1) vaccine in various age groups. N Engl J Med. 2009 Dec 17;361(25):2414-23. doi: 10.1056/NEJMoa0908535. Epub 2009 Oct 21. PMID 19846844
- BACKGROUNDMazza JJ, Yale SH, Arrowood JR, Reynolds CE, Glurich I, Chyou PH, Linneman JG, Reed KD. Efficacy of the influenza vaccine in patients with malignant lymphoma. Clin Med Res. 2005 Nov;3(4):214-20. doi: 10.3121/cmr.3.4.214. PMID 16303886
- BACKGROUNDLjungman P, Nahi H, Linde A. Vaccination of patients with haematological malignancies with one or two doses of influenza vaccine: a randomised study. Br J Haematol. 2005 Jul;130(1):96-8. doi: 10.1111/j.1365-2141.2005.05582.x. PMID 15982350