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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013013
Receipt No. R000015099
Scientific Title The analysis of mucosal immune responses induced by intranasal administration of an inactivated influenza virus vaccine in human (IV).
Date of disclosure of the study information 2014/01/30
Last modified on 2019/01/25

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Basic information
Public title The analysis of mucosal immune responses induced by intranasal administration of an inactivated influenza virus vaccine in human (IV).
Acronym The analysis of antibody responses induced by intranasal vaccination with inactivated whole-virus vaccines.
Scientific Title The analysis of mucosal immune responses induced by intranasal administration of an inactivated influenza virus vaccine in human (IV).
Scientific Title:Acronym The analysis of antibody responses induced by intranasal vaccination with inactivated whole-virus vaccines.
Region
Japan

Condition
Condition Influenza
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The goal of this study is to measure antibody responses in healthy volunteers receiving an intranasal vaccination with trivalent inactivated whole-virus vaccine (containing 45 ug HA/dose of influenza A/H1N1 virus, 45 ug HA/dose of influenza A/H3N2 virus and 45 ug HA/dose of influenza B virus) in the presence of carboxy vinyl polymer (CVP), that increase the viscosity of vaccine. The influence of nasal wash held one day before or just prior to the administration is estimated. In addition, the analysis of antibodies secreted on the surface of nasal mucosa is performed.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Neutralization, HI, and HA-specific antibody titers before and after intranasal vaccination. The analysis of antibodies secreted on the surface of nasal mucosa. Survey on side reaction after vaccination.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Vaccine
Interventions/Control_1 Intranasal administration of inactivated whole-virus influenza vaccines (each 45 ug HA/dose) with CVP is performed twice with a 3 week interval. The collection of nasal wash samples is performed one day before each administration. For volunteers who agree with the analysis of antibodies secreted on the surface of nasal mucosa, additional collection of nasal wash samples will be performed 3 weeks after the second intranasal vaccination.
Interventions/Control_2 Intranasal administration of inactivated whole-virus influenza vaccines (each 45 ug HA/dose) with CVP is performed twice with a 3 week interval. The collection of nasal wash samples is performed just prior to each administration. For volunteers who agree with the analysis of antibodies secreted on the surface of nasal mucosa, additional collection of nasal wash samples will be performed 3 weeks after the second intranasal vaccination.
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Healthy adult volunteers who are interested in the open recruitment for our study, and agree with our study contents, as confirmed by giving their informed consent before the onset of the study.
Key exclusion criteria 1. Volunteers with a fever at the time of planned vaccination.
2. Volunteers with serious acute diseases.
3. Volunteers considered inappropriate to be inoculated vaccine.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideki Hasegawa
Organization National Institute of Infectious Diseases
Division name Department of Pathology
Zip code
Address Toyama 1-23-1, Shinjuku-ku, Tokyo
TEL 03-5285-1111
Email hasegawa@nih.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideki Hasegawa
Organization National Institute of Infectious Diseases
Division name Department of Pathology
Zip code
Address Toyama 1-23-1, Shinjuku-ku, Tokyo
TEL 03-5285-1111
Homepage URL
Email hasegawa@nih.go.jp

Sponsor
Institute National Institute of Infectious Diseases
Institute
Department

Funding Source
Organization Health and Labour Sciences Research Grants
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2014 Year 01 Month 30 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
2014 Year 01 Month 10 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 01 Month 30 Day
Last modified on
2019 Year 01 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015099

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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