Prevention of influenza
Conditions
Interventions
Evaluate immunogenicity and safety after immunization with adjuvanted influenza A (H5N1) vaccine of Qinghai strain to the individuals, who had vaccinated twice with Indonesia strain or Anhui strain in
Sponsors
Clinical Research Center, National Hospital Organization
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Individuals, who had been vaccinated twice with adjuvanted influenza A (H5N1) vaccine of Indonesia strain or Anhui strain in 2008 or individuals, who have not been vaccinated with influenza A (H5N1) vaccine 2)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 Swine Influenza A (H5N1) virus infection. (obtained by 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 with influenza vaccine 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 (counting from the date 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 (counting from the date of vaccination).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measurement of neutralizing antibody to Qinghai, Vietnam, Indonesia and Anhui strain | — |
Countries
Japan
Outcome results
None listed