Prevention of influenza
Conditions
Interventions
Evaluate immunogenicity using neutralizing antibody and safety of the adult healthy volunteers after administration of the two-dose of adjuvanted influenza A (H5N1) vaccine of Indonesia strain, 60days
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 (H5N1) vaccine 2)Individuals, who could be follow up survey for five years after inoculation 3)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 (H5N1) 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)Individuals who are deemed to be inappropriate by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measurement of neutralizing antibody to influenza A(H5N1) | — |
Countries
Japan
Contacts
Public ContactSuminobu Ito
Clinical Research Center, National Hospital Organization Clinical trial promotion office,
Outcome results
None listed