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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000002943
Receipt No. R000003576
Scientific Title Trial of immunogenicity of a monovalent influenza A (H1N1) 2009 vaccine
Date of disclosure of the study information 2010/01/04
Last modified on 2016/02/24

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Basic information
Public title Trial of immunogenicity of a monovalent influenza A (H1N1) 2009 vaccine
Acronym A randomized non-blind dose-controlled phase 2/3 trial of monovalent influenza HA vaccine derived from swine origin influenza A(H1N1) virus(Investigator-initiated multi-center clinical trial)
Scientific Title Trial of immunogenicity of a monovalent influenza A (H1N1) 2009 vaccine
Scientific Title:Acronym A randomized non-blind dose-controlled phase 2/3 trial of monovalent influenza HA vaccine derived from swine origin influenza A(H1N1) virus(Investigator-initiated multi-center clinical trial)
Region
Japan

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

Objectives
Narrative objectives1 Evaluation of immunogenicity after two doses of monovalent influenza A (H1N1) 2009 vaccine subcutaneously or intramuscularily to healthy adult volunteers
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Serum antibody titers were measured prior to the first injection and the second injection (21plus-minus7days starting with the first injection) and 21 days after the second dose(neutralizing antibody and HI antibody against influenza A (H1N1) 2009 and anti-ganglioside antibodies)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Vaccine
Interventions/Control_1 Serum antibody titers obtained prior to vaccination and 21 days after the first and second dose of monovalent influenza A (H1N1) vaccine were tested, and adverse events were reported.
Interventions/Control_2 Monovalent influenza HA vaccine were injected to healthy adult volunteers twice at three-weeks interval, and side reactions were observed and post-vaccination antibody titers were tested.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1)Subjects aged 20 years or older at the time of getting informed consent.
2)Pregnant women were permitted after permission by obstetricians or gynecologists.
3)Subjects, who were able to follow the regulation of the trial, have clinical examination written in the protocol and report their symptoms.
Key exclusion criteria 1)Subjects with the history of Swine Influenza A (H1N1) infection. (obtained by subjects)
2)Subjects vaccinated with Swine Influenza A (H1N1) vaccine previously (obtained by subjects).
3)Subjects, who had history of anaphylaxy to foods or medicines previously.
4)Subjects with severe diseases in cardiovascular, blood, respiratory, liver, kidney, digestive or neurological systems in their clinical recording.
5)Subjects with a history of acute disseminated encephalomyelitis and Guillain-Barre syndrome in the past.
6)Subjects aged 75 years or older living alone, or suffered from dementia and unable to have their consent.
7)Subjects participated in a clinical trial with influenza vaccine within four months (counted from the date of vaccination).
8)Subjects vaccinated with live vaccine within 27 days, or received a dose of inactivated vaccine within six days (counting from the date of vaccination).
9)Subjects received with gamma globulin or blood transfusion within three months, or received the formulation of high dose of gamma globulin therapy (200 mg / kg or more) within six months (counting from the date of vaccination).
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name 1)TAKASHI NAKANO,2)MASARU IDO,3)KEIZO HORIBE,4)AKIRA SHIMATSU
Organization 1)Mie National Hospital,2)Mie,Chuo Medical Center,3)Nagoya Medical Center,4)Kyoto Medical Center
Division name 1)Institute for Clinical Research Department of Clinical Research,2)Health and Development Department of Health and Development,3)Clinical Research Center,4)Clinical Research Institute
Zip code
Address 1)357,Ozato,Kubota,Tsu,Mie,2)2158-5,Hisai,Myojin-cho,Tsu,Mie,3)4-1-1,Sannomaru,Naka-ku,Nagoya,4)1-1,Mukaihata-cho,Fukakusa,Fushimi-ku,Kyoto
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization National Hospital Organization Headquarters
Division name Medical Research Division
Zip code
Address 2-5-21,Higasigaoka,Meguro-ku,Tokyo
TEL
Homepage URL
Email

Sponsor
Institute National Hospital Organization Headquarters
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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
2010 Year 01 Month 04 Day

Related information
URL releasing protocol
Publication of results Published

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 Main results already published
Date of protocol fixation
2009 Year 08 Month 11 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 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
2009 Year 12 Month 25 Day
Last modified on
2016 Year 02 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003576

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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