Clinical trial · Interventional
Study Comparing High-Dose Flu Vaccine to Standard Vaccine in Cancer Patients Less Than 65 Receiving Chemotherapy
A Randomized Pilot Study Comparing High-Dose Influenza Vaccine to Standard-Dose Influenza Vaccine in Adult Oncology Patients Less Than 65 Years Receiving Chemotherapy
NCT01666782CI-TRIAL-00022726IMMUNEcompletedPhase 2Results postedClinicalTrials.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 safety and immunogenicity of high dose influenza vaccine has not been studied in young patients receiving chemotherapy. This study will evaluate and compare the immunogenicity and safety of high dose influenza to standard dose influenza vaccine in adult oncology patients who are younger than 65 years old receiving chemotherapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Influenza Viral Infections | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High-Dose Influenza Vaccine | Biological | — | UNRESOLVED |
| Standard Trivalent Influenza Vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- High-Dose Influenza Vaccine
- interventionNames
- Biological: High-Dose Influenza Vaccine
- type
- ACTIVE_COMPARATOR
- label
- Standard Trivalent Influenza Vaccine
- interventionNames
- Biological: Standard Trivalent Influenza Vaccine
Primary outcomes (1)
- measure
- The Geometric Mean Titer (GMT) of High-dose Influenza Vaccine vs the Standard Trivalent Influenza Vaccine in Adult Subjects on Chemotherapy Who Are Less Than 65 Years Old.
- timeFrame
- Baseline and 28 days
- description
- Measure Hemagglutination Inhibition (HAI) Geometric Mean Titer (GMT) immunogenicity of high-dose (HD) and standard dose (SD) vaccine before and after vaccination at day 28.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 64 Years
Show eligibility criteria text
Inclusion Criteria: 1. 18 years old to less than 65 years old 2. Subjects with malignancy must be receiving chemotherapy 3. Medically stable 4. Able to understand and willingness to sign a written informed consent 5. Able to comply with study procedures 6. Life expectancy of more than 3 months 7. Adequate organ function: * ANC \>1000/mm3 * Platelet \>100,000/uL * Creatinine \<2 mg/dL * AST and ALT \<3 times the ULN Exclusion Criteria: 1. Allergy to eggs 2. Prior allergy to Influenza Vaccine 3. History of Guillain-Barre Syndrome 4. Current febrile illness 5. Other immunosuppressive disease (recipients of solid organ transplant, uncontrolled HIV) 6. Autologous or Allogenic Stem Cell Transplant with in a year 7. Current immunotherapy or immunochemotherapy in the last 6 months (rituximab or ofatumumab)
References
Publications (1)
- DERIVEDJamshed S, Walsh EE, Dimitroff LJ, Santelli JS, Falsey AR. Improved immunogenicity of high-dose influenza vaccine compared to standard-dose influenza vaccine in adult oncology patients younger than 65 years receiving chemotherapy: A pilot randomized clinical trial. Vaccine. 2016 Jan 27;34(5):630-635. doi: 10.1016/j.vaccine.2015.12.037. Epub 2015 Dec 22. PMID 26721330