UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002943
Receipt number 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 10:55:22

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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 or person

Institute

National Hospital Organization Headquarters

Institute

Department

Personal name



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

Value
https://center6.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