Prevention Clinical Trial
Official title:
Safety and Immunogenicity of Booster Dose of An Inactivated,Adjuvanted Whole-Virion Pandemic Influenza (H5N1)Vaccine in Two-Dose Primed Healthy Adults: A Single Center, Non-Randomized Clinical Trial
Verified date | April 2008 |
Source | Sinovac Biotech Co., Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Interventional |
A single center, non-randomized clinical trial in two-dose primed healthy adults to evaluate the safety and immunogenicity of a booster dose of an inactivated pandemic influenza (H5N1) vaccine (whole-virion, aluminium-adjuvanted).
Status | Completed |
Enrollment | 57 |
Est. completion date | March 2008 |
Est. primary completion date | March 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 19 Years to 61 Years |
Eligibility |
Inclusion Criteria: - Had received two-dose priming vaccination in previous phase I trial - Be able to show legal identity card for the sake of recruitment - Be able to understand and sign the informed consent. Exclusion Criteria: - Woman: Who breast-feeding or planning to become pregnant during the study - Any history of allergic reactions to vaccines or eggs - Autoimmune disease or immunodeficiency - Diabetes mellitus (type I or II), with the exception of gestational diabetes - Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years - Hypertension that was not well controlled by medication or is more than 145/95 mmHg at enrollment - Active malignancy or treated malignancy for which there is not reasonable assurance of sustained cure or malignancy that is likely to recur during the period of study - Guillain-Barre Syndrome - Women subjects with positive urinary pregnancy test - Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months - History of any blood products administration within 3 months before the dosing - Administration of any other investigational research agents within 30 days before the dosing - Administration of any live attenuated vaccine within 30 days before the dosing - Administration of subunit or inactivated vaccines, e.g. pneumococcal vaccine, or allergy treatment with antigen injections, within 14 days before the dosing - Be receiving anti-TB prophylaxis or therapy currently - Axillary temperature >37.0 centigrade at the time of dosing - Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder requiring therapy that has not been well controlled on medication for the past two years; disorder requiring lithium; or suicidal ideation occurring within five years prior to enrollment - Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent. |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
China | China-Japan Friendship Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Sinovac Biotech Co., Ltd | Centers for Disease Control and Prevention, China |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HI antibody Neutralization antibody | 15 and 30 days after the booster dose | No | |
Secondary | local adverse reactions systemic adverse reactions temperature | 3 days after booster dose | Yes |
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