Prevention of influenza
Conditions
Interventions
BK1313 High Dose with adjuvant Group (50 persons per group) is intramuscularly vaccinated with the vaccine containing 30microg/dose of hemagglutinin (HA) mixed with aluminum hydroxide (0.15mg). For
Sponsors
Clinical Research Center, National Hospital Organization
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Individuals, who have not been vaccinated with influenza A (H7N9) vaccine (over 20 years old) 2)Individuals, who could be consent by document that have been approved by IRB 3)Individuals, who could be follow up survey for five years after inoculation 4)Individuals, who could keep the compliance with this study's rules 5)Individuals, who could be followed under the regulation of the clinical trial, could be examined according to the protocol, and could report their symptoms.
Exclusion criteria
Exclusion criteria: 1)Individuals with the history of Avian Influenza A (H7)virus infection.(obtained 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunologic endpoint SRH antibody titer of avian influenza A/H7N9 | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunologic endpoint HI antibody titer and neutralizing antibody titer of avian influenza A/H7N9 | — |
Countries
Japan
Contacts
Public ContactSuminobu Ito
Clinical Research Center, National Hospital Organization Clinical Research Division
Outcome results
None listed