Safety of the pandemic influenza A (H5N1) vaccination of Egyptian stain on 1,000 healthy adult volunteers and it's effectiveness if H5N1 influenza might be spread.
- Conditions
- Prevention of influenza
- Registration Number
- JPRN-UMIN000011816
- 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
- 1000
Not provided
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Survey for safety from first administration influenza A (H5N1) vaccine to last administration influenza A (H5N1) vaccine after 28days.
- Secondary Outcome Measures
Name Time Method Effectiveness of the vaccine might be evaluated based on the incidence of influenza like illness, when H5N1 type influenza is spread within five years.