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The clinical study of the efficacy of two doses of influenza vaccination to the patients with malignancies.

The clinical study of the efficacy of two doses of influenza vaccination to the patients with malignancies. - The clinical study of the efficacy of two doses of influenza vaccination to the patients with malignancies.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000011918
Enrollment
100
Registered
2013-11-01
Start date
2013-11-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Any kind of malignancies

Interventions

We use two doses of influenza vaccine to prevent influenza infection and measure HI titer.

Sponsors

Division of Medical Oncology/Hematology, Department of Medicine, Kobe University Graduate School of Medicine, Kobe, Japan
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1>Patients of more than 20 years old with the diagnosis of malignancy from pathology receiving chemo therapy. We choose chemotherapy as suspecting decrease of lymphocyte, using prednisolone more than 20mg for treatment or reducing side effect of chemotherapy, or molecular target therapy reducing the immune system. 2>Patients reseived immunoglobulins within the presious 6 weeks prior to vaccination. 3>Patients with a life expectancy of at least 6months. 4>The patients whose ECOG performance status are 0 to 2. 5>The patients who are more than 20 years old, and agree to participate in this study with document.

Exclusion criteria

Exclusion criteria: 1>The patients who had fever at the time of vaccination. 2>The patients who had an acute febrile illness at the time of vaccination. 3>The patients known anaphylactic shock to the ingredient of the influenza vaccine. 4>The patients received corticosteroid (0.3mg/kg of prednisone minimum dose.) 5>The patients with platelet count less than 20000/µl. 6>The patients received a live vaccine within 4weeks or inactivating vaccine or toxoid within 1week. 7>The patients treating only with hormonal therapy. 8>The patients whose doctor judge as ineligible

Design outcomes

Primary

MeasureTime frame
We evaluate the efficacy of two doses of influenza vaccine in patients with malignancies receiving chemotherapy. Influenza immunity was defined as HI titre of >40 to all three influenza subtypes after vaccination.

Countries

Japan

Contacts

Public ContactYukinari Sanada

Department of Medicine, Kobe University Graduate School of Medicine Division of Medical Oncology/Hematology

sanaday@med.kobe-u.ac.jp078-382-5820

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026