Prospective cohort study on immunogenicity, safety and efficacy of seasonal influenza vaccination to healthy adults who received non-adjuvanted or AS03A-adjuvanted pandemic influenza H1N1 vaccination one year ago
- Conditions
- healthy adults
- Registration Number
- JPRN-UMIN000004631
- Lead Sponsor
- ational Hospital Organization, Tokyo National Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Not provided
1) Persons who have ever had serious adverse reactions after vaccination of non-adjuvanted or AS03A-adjuvanted pandemic influenza H1N1 vaccine. 2) Persons who were given non-adjuvanted or AS03A-adjuvanted pandemic influenza H1N1 vaccine for the last 10 months 3) Persons who have had seasonal influenza vaccination (2010/2011) 4) Persons who have ever showed anaphylaxis due to food or drugs 5) Persons who had past history of cardiovascular diseases, hematological diseases, pulmonary diseases, liver diseases, renal diseases, neurological diseases, and psychiatric diseases. 6) Persons who have had Guillain-Barre syndrome or acute disseminated encephalomyelitis 7) Persons who were given new drugs by participating the other trial within four months in the past. 8) Persons who were given live vaccine within 27 days in the past or inactivate vaccine within 6 days in the past. 9) Persons who will be given the other vaccine during this study. 10) Persons who were given blood transfusion or gamma globulin within 3 months in the past or who were given a great amount of gamma globulin (over 200 mg/kg) within 6 months in the past. 11) Persons who are not appropriate to participate in this study because of some reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method