influenza virus infection
Conditions
Interventions
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 standa
Sponsors
Osaka University hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy Japanese volunteers aged 20-64 years old.
Exclusion criteria
Exclusion criteria: 1.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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| to asses the rate of adverse events elicited during 7days after subcutaneous injection of HP-beta-CyD ajuvanted influenza split vaccine | — |
Countries
Japan
Contacts
Public ContactAkane Watanabe
Graduate School of Medicine, Osaka University Department of Respiratory Medicine and Clinical Immunology
Outcome results
None listed