To investigate efficacy and safety of KD-295-H7N9
- Conditions
- Prevention of avian influenza
- Registration Number
- JPRN-UMIN000016577
- Lead Sponsor
- Clinical Research Center, National Hospital Organization
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Not provided
1)Individuals with the history of Avian Influenza A (H7) virus infection. (hearing from subjects) 2)Individuals, who had history of anaphylaxis to foods or medicines previously. 3)Individuals with severe diseases in cardiovascular, blood, respiratory, liver, kidney, digestive or neurological systems in their clinical recording. 4)Individuals with a history of acute disseminated encephalomyelitis and Guillain-Barre syndrome in the past. 5)Individuals participated in a clinical trial within four months (counted from the date of vaccination). 6)Individuals vaccinated with live vaccine within 27 days, or received a dose of inactivated vaccine within six days (including the day of vaccination). 7)Individuals 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 (including the day of vaccination). 8)From the day of the first administration to the last day of follow-up, Individuals or partners, who wish to become pregnant , and Individuals , who could not perform the appropriate method of contraception. 9)A breast-feeding women, a pregnant women or a suspected pregnancy woman 10)Individuals, who are deemed to be inappropriate by the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Immunologic endpoint HI antibody titer of avian influenza A/H7N9
- Secondary Outcome Measures
Name Time Method Immunologic endpoint neutralizing antibody titer of avian influenza A/H7N9