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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028530
Receipt No. 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 2018/08/07

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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
Middle name
Last name Sumiyuki Nishida
Organization Graduate School of Medicine, Osaka University
Division name Department of Respiratory Medicine and Clinical Immunology
Zip code
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
Middle name
Last name Akane Watanabe
Organization Graduate School of Medicine, Osaka University
Division name Department of Respiratory Medicine and Clinical Immunology
Zip code
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
Institute Osaka University hospital
Institute
Department

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
Address
Tel
Email

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
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
2018 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.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


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