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
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
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
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
