NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000028530

Registered date:01/09/2017

A phase1 study of Hydroxypropyl-beta-cyclodextrin(HP-beta-CyD)-adjuvanted influenza split vaccine

Basic Information

Public titleA phase1 study of Hydroxypropyl-beta-cyclodextrin(HP-beta-CyD)-adjuvanted influenza split vaccine
Scientific title
Recruitment statusComplete: follow-up complete
Health condition(s) or Problem(s) studiedinfluenza virus infection
Study typeInterventional
Phase
Study design
Intervention(s)In HP-beta-CyD containing vaccine group,subjects are administered influenza HA split-vaccine containing 9 micro-g/HA/dose and 20%W/V HP-beta-CyD with a dose of 0.5mL in subcutaneous route. In standard vaccine group,subjects are administered influenza HA split-vaccine containing 15micro-g/HA/dose with a dose of 0.5mL in subcutaneous route.
Sample Size36
Date of first enrollment2017/10/01
Completion dateNone
Countries of recruitmentJapan

Outcome(s)

Primary Outcometo asses the rate of adverse events elicited during 7days after subcutaneous injection of HP-beta-CyD ajuvanted influenza split vaccine
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum64years-old
GenderMale and Female
Include criteriaHealthy Japanese volunteers aged 20-64 years old.
Exclude criteria1.having following disease and not controlled despite the medication;cardiac disease,renal disease,hepatic disease,hematologic disease,autoimmune disease or developmental disorder. 2.any history of seasonal influenza in the past 6 months 3.any seasonal vaccination in the past 6 months 4.any scheduled to any other vaccination during this trial 5.any history of anaphylaxis to food, medicine or vaccine 6.any history of anaphylaxis or any likely to allergic reaction to components of test drug,egg,chicken,or other element derived from fowl 7.any history of following disease:acute disseminating encephalomyelopathy,Guillain Barre syndrome,thrombocytopenic purpura, thrombocytopenia, vasculitis, encephalopathy/encephalitis, myelitis, Stevens Johnson syndrome, or nephrotic syndrome 8.administration with any live vaccine in the past 27 days 9.administration with any inactivated/toxoid vaccine in the past 6 days 10.any history of having a blood transfusion or administration with gamma globulin in the past 3 months 11.any history of administration with more than 200 mg/kg of gamma globulin in the past 6 months 12.administration with any investigative drug in the past 4 months in clinical trials 13.no intention to prevent pregnancy during this clinicaltrial 14.being judged as inadequate for joining the clinical trial by investigators

Related Information

Primary SponsorOsaka University hospital
Secondary
Source(s)Kitasato-Daiichisankyo vaccine

Secondary Identifiers

Secondary ID

Contact

public contact
Name Akane Watanabe
Address 2-2, Yamada-oka, Suita city, Osaka, Japan Japan
Telephone 06-6879-3831
E-mail a.watanabe@imed3.med.osaka-u.ac.jp
Affiliation Graduate School of Medicine, Osaka University Department of Respiratory Medicine and Clinical Immunology
scientific contact
Name Sumiyuki Nishida
Address 2-2, Yamada-oka, Suita city, Osaka, Japan Japan
Telephone 06-6879-3831
E-mail sumiyuki-n@imed3.med.osaka-u.ac.jp
Affiliation Graduate School of Medicine, Osaka University Department of Respiratory Medicine and Clinical Immunology

Ethics Reviews

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Summary Results

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Baseline Characteristics
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IPD sharing statement

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