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

UMIN ID: UMIN000028530

Registered date:01/09/2017

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: influenza virus infection
• Date of first enrollment: 2017/10/01
• Target sample size: 36
• Countries of recruitment: Japan
• Study type: Interventional

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.

Outcome(s)

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

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 64years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Osaka University hospital
• Source(s) of Monetary Support: Kitasato-Daiichisankyo vaccine