Clinical trial · Interventional
High-Dose Trivalent Influenza Vaccine in Inducing Immune Response Patients With Central Nervous System Tumors
A Pilot Single Arm Study of High-Dose Influenza Vaccine Immunogenicity in Patients With Central Nervous System Tumors
- 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)
This pilot clinical trial studies high-dose trivalent influenza vaccine in inducing immune response patients with central nervous system tumors. Studying samples of blood in the laboratory from patients receiving trivalent influenza vaccine may help doctors learn more about the effects of trivalent influenza vaccine on cells. It may also help doctors understand how well patients respond to treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Central Nervous System Neoplasm | Central Nervous System Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| trivalent influenza vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Basic science (trivalent influenza vaccine)
- description
- Patients receive trivalent influenza vaccine on day 1.
- interventionNames
- Biological: trivalent influenza vaccine
- Other: laboratory biomarker analysis
Primary outcomes (2)
- measure
- Estimation of geometric mean titer (GMT) seroconversion, defined as the percentage of patients with at least a four-fold increase in hemagglutinin inhibition (HI) antibodies
- timeFrame
- Baseline
- measure
- Estimation of GMT seroconversion, defined as the percentage of patients with at least a four-fold increase in HI antibodies
- timeFrame
- Day 28
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have a clinical diagnosis of a primary central nervous system tumor * Patients must be eligible to receive the influenza vaccine * Patients must be willing to receive the Fluzone® high-dose seasonal influenza vaccine * Patients must be willing and able to sign an Institutional Review Board (IRB)-approved written informed consent document Exclusion Criteria: * Patients unable to receive the high-dose influenza vaccine due to history of allergy to egg proteins, allergy to influenza vaccine component, acute febrile illness at the time of proposed vaccine administration, history of clinically or virologically confirmed influenza infection in the previous 6 months, contraindication to intramuscular injections, Guillain-Barré syndrome, or other contraindication to the vaccine * Patients who have received the 2013-2014 annual influenza vaccine prior to being considered for enrollment on this study
References
Publications (0)
Data not yet available