UMIN-CTR Clinical Trial

Public title

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

Acronym

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

Scientific Title

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

Scientific Title:Acronym

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

Region

Japan

Condition

Any kind of malignancies

Classification by specialty

Hematology and clinical oncology

Adult

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

This prospective study is performed to determine the efficacy of two doses of influenza vaccination in patients with malignancies receiving chemotherapy.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

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.

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Vaccine

Interventions/Control_1

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

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key 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.

Key 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

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Hironobu Minami

Organization

Department of Medicine, Kobe University Graduate School of Medicine

Division name

Division of Medical Oncology/Hematology

Zip code

Address

7-5-1, Kusunoki-Cho, Chuo-ku, Kobe city, Hyogo prefecture, Japan

TEL

078-382-5820

Email

hminami@med.kobe-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Yukinari Sanada

Organization

Department of Medicine, Kobe University Graduate School of Medicine

Division name

Division of Medical Oncology/Hematology

Zip code

Address

7-5-1, Kusunoki-Cho, Chuo-ku, Kobe city, Hyogo prefecture, Japan

TEL

078-382-5820

Homepage URL

Email

sanaday@med.kobe-u.ac.jp

Institute

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

Institute

Department

Personal name

Organization

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

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

11

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2013

Year

09

Month

30

Day

Date of IRB

Anticipated trial start date

2013

Year

11

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

09

Month

30

Day

Last modified on

2013

Year

09

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013919