Unique ID issued by UMIN | UMIN000015324 |
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Receipt number | R000017819 |
Scientific Title | Investigation into clinical data of quadrivalent influenza vaccination |
Date of disclosure of the study information | 2014/10/02 |
Last modified on | 2018/04/05 09:12:58 |
Investigation into clinical data of quadrivalent influenza vaccination
Clinical research on quadrivalent influenza vaccine(QIV-FLU)
Investigation into clinical data of quadrivalent influenza vaccination
Clinical research on quadrivalent influenza vaccine(QIV-FLU)
Japan |
Prevention of influenza
Pediatrics |
Others
NO
Evaluation of immunogenicity and safety after one or two doses of quadrivalent influenza vaccine subcutaneously to healthy child volunteers
Safety,Efficacy
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(HI antibody against influenza A and B)
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Prevention
Vaccine |
Serum antibody titers obtained prior to vaccination and 21-28 days after the first and second dose of quadrivalent influenza vaccine were tested, and adverse events were reported.
Serum antibody titers obtained prior to vaccination and 21-28 days after the first and second dose of trivalent influenza vaccine were tested, and adverse events were reported.
6 | months-old | <= |
216 | months-old | > |
Male and Female
1)Subjects aged 6 months to 18 years old at the time of first vaccination.
2) Subjects who are able to follow the regulation of the trial and written informed consent can be obtained from their legal guardian.
1)Subjects with the history of influenza infection within 6 months (counted from the date of vaccination). (obtained by guardians)
2)Subjects vaccinated with influenza vaccine within 6 months (counted from the date of vaccination).
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 Guillain-Barre syndrome, acute disseminated encephalomyelitis, thrombocytopenic purpura, thrombocytopenia, anaphylactoid purpura, encephalitis,encephalopathy and myelitis in the past.
6)Subjects vaccinated with live vaccine within 27 days, or received a dose of inactivated vaccine,toxoid within six days (counting from the date of vaccination).
7)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).
8)Subjects judged as inadequate by the researchers.
384
1st name | |
Middle name | |
Last name | SHIGERU SUGA |
National Hospital Organization Mie Hospital
Instisute for Clinical Research
357,Ozato,Kubota,Tsu,Mie
059-232-2531
sugas@mie-m.hosp.go.jp
1st name | |
Middle name | |
Last name | SHIGERU SUGA |
National Hospital Organization Mie Hospital
Instisute for Clinical Research
357,Ozato,Kubota,Tsu,Mie
059-232-2531
sugas@mie-m.hosp.go.jp
National Hospital Organization Mie Hospital
1)The Chemo-Sero-Therapeutic Research Institute
2)KITASATO DAIICHI SANKYO VACCINE CO., LTD.
3)Denka Seiken Co., Ltd.
4)The Research Foundation for Microbial Diseases of Osaka University
Profit organization
NO
三重病院(三重県)、落合小児科医院(三重県)、白子クリニック小児科(三重県)、すずかこどもクリニック(三重県)、まつだ小児科クリニック(三重県)、うめもとこどもクリニック(三重県)、かとう小児科(三重県)、くまがい小児科(北海道)、さいわいこどもクリニック(東京都)、岡藤小児科医院(兵庫県)、鈴木小児科医院(山口県)
2014 | Year | 10 | Month | 02 | Day |
Unpublished
Completed
2014 | Year | 07 | Month | 08 | Day |
2014 | Year | 10 | Month | 01 | Day |
2014 | Year | 10 | Month | 02 | Day |
2018 | Year | 04 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017819
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