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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001182
Receipt No. R000001438
Scientific Title A phase I/II study of UMN-0501 (prepandemic recombinant hemagglutinin influenza vaccine) administrated intramuscularly in healthy, 20 to 40 years of age, male volunteers investigating it's safety, tolerability and immunogenicity. (single center, ascending doses, open label)
Date of disclosure of the study information 2008/06/18
Last modified on 2009/05/01

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Basic information
Public title A phase I/II study of UMN-0501 (prepandemic recombinant hemagglutinin influenza vaccine) administrated intramuscularly in healthy, 20 to 40 years of age, male volunteers investigating it's safety, tolerability and immunogenicity. (single center, ascending doses, open label)
Acronym A phase I/II clinical study of UMN-0501 for healthy adult males
(single center, ascending dose, open label study)
Scientific Title A phase I/II study of UMN-0501 (prepandemic recombinant hemagglutinin influenza vaccine) administrated intramuscularly in healthy, 20 to 40 years of age, male volunteers investigating it's safety, tolerability and immunogenicity. (single center, ascending doses, open label)
Scientific Title:Acronym A phase I/II clinical study of UMN-0501 for healthy adult males
(single center, ascending dose, open label study)
Region
Japan

Condition
Condition Prevention of influenza pandemic
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the safety, tolerability and immunogenicity of after 2 intramuscular doses of prepandemic recombinant hemagglutinin influenza vaccine.
To investigate the immunogenicity of several UMN-0501 with different components and titer of HAI/microneutralizaion after 21 days of 2 intramuscular doses of UMN-0501.
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I,II

Assessment
Primary outcomes To investigate the safety and tolerability of 2 intramuscular doses of prepandemic recombinant hemagglutinin influenza vaccine, UMN-0501.
To investigate the HAI/microneutralizaion titer after 21 days of 2 intramuscular doses of UMN-0501.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 5
Purpose of intervention Prevention
Type of intervention
Vaccine
Interventions/Control_1 Administration of 5µg recombinant hemagglutinin with Alum adjuvant.
2 vaccinations, Day 0 and Day 21
Interventions/Control_2 Administration of 15µg recombinant hemagglutinin.
2 vaccinations, Day 0 and Day 21
Interventions/Control_3 Administration of 15µg recombinant hemagglutinin with Alum adjuvant.
2 vaccinations, Day 0 and Day 21
Interventions/Control_4 Administration of 45µg recombinant hemagglutinin.
2 vaccinations, Day 0 and Day 21
Interventions/Control_5 Administration of 45µg recombinant hemagglutinin with Alum adjuvant.
2 vaccinations, Day 0 and Day 21
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
40 years-old >=
Gender Male
Key inclusion criteria Healthy adult males ages 20-40 years.
Provides informed consent prior to any study procedures.
Key exclusion criteria Plans to receive of any other licensed vaccines during study period.
Has a history of a H5 type of influenza virus infection or receipt of a H5 type influenza vaccine.
Acute fever illness (greater than 39.0C) within 2 days of vaccination.
Has a history of Guillan-Barre syndrome or ADEM.
Has a history of immunodeficient or has a close relative with congenital immune deficiency.
Target sample size 125

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name TETSUO NAKAYAMA
Organization KITASATO UNIVERSITY
KITASATO INSTITUTE FOR LIFE SCIENCES
Division name Laboratory of Virology
Zip code
Address 5-9-1 SHIROKANE, MINATO-KU, TOKYO, JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization UMN Pharma Inc.
Division name Clinical Development Division
Zip code
Address
TEL
Homepage URL
Email 0501clinical@umnpharma.com

Sponsor
Institute UMN Pharma Inc.
Institute
Department

Funding Source
Organization UMN Pharma Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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
2008 Year 06 Month 18 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.who.int/vaccine_research/diseases/influenza/120209_Shu-Ichi_Kanazashi.pdf
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
2008 Year 02 Month 27 Day
Date of IRB
Anticipated trial start date
2008 Year 06 Month 01 Day
Last follow-up date
2008 Year 10 Month 01 Day
Date of closure to data entry
2008 Year 11 Month 01 Day
Date trial data considered complete
2008 Year 11 Month 01 Day
Date analysis concluded
2008 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 06 Month 10 Day
Last modified on
2009 Year 05 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001438

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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