Influenza, Human Clinical Trial
Official title:
Persistence Study of Immune Response After Vaccination With Influenza Vaccine in Healthy Population
This clinical study will be performed in subjects aged 12-60 years old enrolled in NCT01310374 who received 2010 seasonal influenza vaccine to evaluate the persistence of the immune response of influenza vaccine up to 24 months after vaccination.
Status | Completed |
Enrollment | 207 |
Est. completion date | July 2013 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 12 Years to 60 Years |
Eligibility |
Inclusion Criteria: - aged 12-60 years old - male or non-pregnant female - volunteers received 2010 seasonal influenza vaccine - clinically healthy as determined by: medical history inquiring and physical examination - provide written informed consents before joining the trial Exclusion Criteria: - without history of 2010 seasonal influenza vaccine administration, - allergic to any ingredient of vaccine, - autoimmune disease or immunodeficiency, - severe adverse reaction after vaccination, such as allergies, hives, breathing difficulties, angioedema or abdominal pain, - severe acute and chronic diseases - axillary temperature over 37.0? at the time of vaccination. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
China | Tuoketuo Centers for Disease Control & Prevention | Tuoketuo County | Inner Mongolia |
Lead Sponsor | Collaborator |
---|---|
Centers for Disease Control and Prevention, China |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change from serum antibodies against vaccine-related influenza virus at 6,12,18,24 months | Persistence of antibodies in all subjects with respect to components of the investigational vaccine - month 6,12,18,24 | 6,12,18,24 months after the primary vaccination | No |
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