Status:
COMPLETED
Safety and Immunogenicity of Booster Dose of An Inactivated,Adjuvanted Whole-Virion Pandemic Influenza(H5N1)Vaccine
Lead Sponsor:
Sinovac Biotech Co., Ltd
Collaborating Sponsors:
Centers for Disease Control and Prevention, China
Conditions:
Pandemic Influenza Vaccine
Prevention
Eligibility:
All Genders
19-61 years
Phase:
PHASE1
Brief Summary
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-...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00660257
Start Date
January 1 2007
End Date
March 1 2008
Last Update
April 17 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China