Unique ID issued by UMIN | UMIN000002943 |
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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 |
Trial of immunogenicity of a monovalent influenza A (H1N1) 2009 vaccine
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)
Trial of immunogenicity of a monovalent influenza A (H1N1) 2009 vaccine
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)
Japan |
Prevention of influenza
Infectious disease |
Others
NO
Evaluation of immunogenicity after two doses of monovalent influenza A (H1N1) 2009 vaccine subcutaneously or intramuscularily to healthy adult volunteers
Pharmacodynamics
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)
Interventional
Parallel
Randomized
Single blind -participants are blinded
Uncontrolled
2
Prevention
Vaccine |
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.
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.
20 | years-old | <= |
Not applicable |
Male and Female
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.
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).
200
1st name | |
Middle name | |
Last name | 1)TAKASHI NAKANO,2)MASARU IDO,3)KEIZO HORIBE,4)AKIRA SHIMATSU |
1)Mie National Hospital,2)Mie,Chuo Medical Center,3)Nagoya Medical Center,4)Kyoto Medical Center
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
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
1st name | |
Middle name | |
Last name |
National Hospital Organization Headquarters
Medical Research Division
2-5-21,Higasigaoka,Meguro-ku,Tokyo
National Hospital Organization Headquarters
None
Other
NO
2010 | Year | 01 | Month | 04 | Day |
Published
Main results already published
2009 | Year | 08 | Month | 11 | Day |
2009 | Year | 09 | Month | 01 | Day |
2009 | Year | 12 | Month | 25 | Day |
2016 | Year | 02 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003576
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