UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028530
Receipt number R000032631
Scientific Title A phase1 study of Hydroxypropyl-beta-cyclodextrin(HP-beta-CyD)-adjuvanted influenza split vaccine
Date of disclosure of the study information 2017/09/01
Last modified on 2023/03/28 12:19:59

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Basic information

Public title

A phase1 study of Hydroxypropyl-beta-cyclodextrin(HP-beta-CyD)-adjuvanted influenza split vaccine

Acronym

A phase1 study of Hydroxypropyl-beta-cyclodextrin(HP-beta-CyD)-adjuvanted influenza split vaccine

Scientific Title

A phase1 study of Hydroxypropyl-beta-cyclodextrin(HP-beta-CyD)-adjuvanted influenza split vaccine

Scientific Title:Acronym

A phase1 study of Hydroxypropyl-beta-cyclodextrin(HP-beta-CyD)-adjuvanted influenza split vaccine

Region

Japan


Condition

Condition

influenza virus infection

Classification by specialty

Infectious disease

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety and immunogenicity of Hydroxypropyl-beta-cyclodextrin adjuvanted influenza split vaccine in healthy Japanese adults.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase I


Assessment

Primary outcomes

to asses the rate of adverse events elicited during 7days after subcutaneous injection of HP-beta-CyD ajuvanted influenza split vaccine

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Vaccine

Interventions/Control_1

In HP-beta-CyD containing vaccine group,subjects are administered influenza HA split-vaccine containing 9 micro-g/HA/dose and 20%W/V HP-beta-CyD with a dose of 0.5mL in subcutaneous route.

Interventions/Control_2

In standard vaccine group,subjects are administered influenza HA split-vaccine containing 15micro-g/HA/dose with a dose of 0.5mL in subcutaneous route.

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

64 years-old >=

Gender

Male and Female

Key inclusion criteria

Healthy Japanese volunteers aged 20-64 years old.

Key exclusion criteria

1.having following disease and not controlled despite the medication;cardiac disease,renal disease,hepatic disease,hematologic disease,autoimmune disease or developmental disorder.
2.any history of seasonal influenza in the past 6 months
3.any seasonal vaccination in the past 6 months
4.any scheduled to any other vaccination during this trial
5.any history of anaphylaxis to food, medicine or vaccine
6.any history of anaphylaxis or any likely to allergic reaction to components of test drug,egg,chicken,or other element derived from fowl
7.any history of following disease:acute disseminating encephalomyelopathy,Guillain Barre syndrome,thrombocytopenic purpura, thrombocytopenia, vasculitis, encephalopathy/encephalitis, myelitis,
Stevens Johnson syndrome, or nephrotic syndrome
8.administration with any live vaccine in the past 27 days
9.administration with any inactivated/toxoid vaccine in the past 6 days
10.any history of having a blood transfusion or administration with gamma globulin in the past 3 months
11.any history of administration with more than 200 mg/kg of gamma globulin in the past 6 months
12.administration with any investigative drug in the past 4 months in clinical trials
13.no intention to prevent pregnancy during this clinicaltrial
14.being judged as inadequate for joining the clinical trial by investigators

Target sample size

36


Research contact person

Name of lead principal investigator

1st name Sumiyuki
Middle name
Last name Nishida

Organization

Graduate School of Medicine, Osaka University

Division name

Department of Respiratory Medicine and Clinical Immunology

Zip code

565-0871

Address

2-2, Yamada-oka, Suita city, Osaka, Japan

TEL

06-6879-3831

Email

sumiyuki-n@imed3.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name Akane
Middle name
Last name Watanabe

Organization

Graduate School of Medicine, Osaka University

Division name

Department of Respiratory Medicine and Clinical Immunology

Zip code

565-0871

Address

2-2, Yamada-oka, Suita city, Osaka, Japan

TEL

06-6879-3831

Homepage URL


Email

a.watanabe@imed3.med.osaka-u.ac.jp


Sponsor or person

Institute

Osaka University hospital

Institute

Department

Personal name



Funding Source

Organization

Kitasato-Daiichisankyo vaccine

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Osaka University Hospital Ethical Review Board

Address

2-2, Ymadaoka, Suita, Osaka, Japan

Tel

06-6210-8296

Email

rinri@hp-crc.med.osaka-u.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2017 Year 09 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 08 Month 15 Day

Date of IRB

2017 Year 09 Month 15 Day

Anticipated trial start date

2017 Year 10 Month 01 Day

Last follow-up date

2017 Year 11 Month 27 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 08 Month 04 Day

Last modified on

2023 Year 03 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032631


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name