Influenza Clinical Trial
Official title:
Safety and Efficacy of Dose Sparing Intradermal 2010/2011 Trivalent Influenza Vaccination With the Novel Microneedle Delivery Device
Verified date | February 2011 |
Source | The University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | Hong Kong: Ethics Committee |
Study type | Interventional |
Intradermal influenza vaccination may result in better efficacy when compare to intramuscular vaccination.
Status | Completed |
Enrollment | 240 |
Est. completion date | February 2011 |
Est. primary completion date | February 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 21 Years and older |
Eligibility |
Inclusion Criteria: - All participants qualified for the HA/ CHP Mass Vaccination Program for TIV 2010/2011 seasonal influenza as stated above: including all elderly at the age of 65 or above and all adult patients at the age of 21 or above that are either healthcare workers or that have a chronic illness including hypertension, diabetes mellitus, ischemic heart disease, cerebrovascular disease, thyroid disease and chronic renal failure. - All patients give written informed consent. - Subjects must be available to complete the study and comply with study procedures. Exclusion Criteria: - Clinically significant immune-related diseases, significant recent co-morbidities and pregnant volunteers. - History or any illness that might interfere with the results of the study or pose additional risk to the subjects due to participation in the study - Have a known allergy to eggs or other components of the Study Vaccines (including gelatin, formaldehyde, octoxinol, thimerosal, and chicken protein), or history of any anaphylaxis, serious vaccine reactions, to any excipients. - Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36 months. - Have an active neoplastic disease or a history of any hematologic malignancy. - Have known active human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C infection or autoimmune hepatitis and cirrhosis. - History of progressive or severe neurological disorders or Guillain-Barré Syndrome. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | The University of Hong Kong, Queen Mary Hospital | Hong Kong | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong | Hospital Authority, Hong Kong |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | seroconversion rate | Seroconversion rate (percentage of subjects with a fourfold increase in antibody titres, providing a minimal post vacination titre of 1:40) on day 21 by TIV 2010/2011 hemagglutination inhibition (HI) between the ID and IM groups | day 21 | No |
Secondary | Adverse events | Adverse events secondary to vaccination with different devices | 30 minutes post vaccination | Yes |
Secondary | Seroprotection rate | percentage of subjects with a post vaccination titre of at least 1:40 | Day 21 | No |
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