Efficacy and safety of the pandemic influenza A(H5N1) vaccination on whether the sequential hetero-strains vaccination would provide wide range of immunogenicity, and whether single-shot vaccination would develop effective priming.
- Conditions
- Prevention of influenza
- Registration Number
- JPRN-UMIN000007027
- 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
- 300
Not provided
1) Individuals with the history of Swine Influenza A (H5N1) virus infection. (obtained fromsubjects) 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
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method