- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00356798
Randomized, Double Blinded, Placebo Control Clinical Trial of Pandemic Influenza Inactive Vaccine on Healthy Subjects
November 8, 2007 updated by: Sinovac Biotech Co., Ltd
The Phase-I Clinical Trial Protocol for the Pandemic Inactivated Influenza Vaccine
Based on pre-clinical trial data and principle of GCP, the objective of phase I clinical trial is to evaluate safety and immunogenicity of Pan-flu vaccine, an inactivated whole virion H5N1 vaccine with aluminium hydroxide adjuvant.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
120
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing
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Beijing, Beijing, China, 100029
- China-Japan Friendship Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Males and females, age from 18 to 60 years old;
- Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process;
- Able and willing to complete the informed consent process.
Exclusion Criteria:
- Woman who is breast-feeding or planning to become pregnant during the following 210 days of study participation;
- Persons who engage in the following occupations: culturist, slaughter, sale and forwarder of avian;
- Subject has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine, such as egg, egg protein, etc;
- Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain;
- Autoimmune disease or immunodeficiency;
- Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that requires the use of oral or intravenous corticosteroids;
- Diabetes mellitus (type I or II), with the exception of gestational diabetes;
- History of thyroidectomy or thyroid disease that required medication within the past 12 months;
- Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years;
- Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws;
- Malignancy that is active 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;
- Seizure disorder other than 1) febrile seizures under the age of two, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) a singular seizure not requiring treatment within the last 3 years;
- Asplenia, functional asplenia or any condition resulting in the absence or removal o the spleen;
- Guillain-Barre Syndrome (GBS);
Abnormal result of laboratory test as below:
- Biochemistry assaying: Alanine Aminotransferase /Serum Glutamate Pyruvate Transaminase (ALT), Total Bilirubine Tbil (TBIL), Direct Bilirubine Tbil (DBIL), Blood Urea Nitrogen (BUN) and Creatinine (Cr).
- Routine blood assaying, routine urine assaying.
- HBsAg positive;
- Pregnancy test positive for female;
Subject has received any of the following substances:
- Immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis).
- Blood products within 3 months prior to initial study vaccine administration.
- Other study drug within 30 days prior to initial study vaccine administration. Live attenuated vaccines within 30 days prior to initial study vaccine administration.
- Medically indicated subunit or killed vaccines, e.g. pneumococcal, or allergy treatment with antigen injections, within 14 days of study vaccine administration.
- Current anti-TB prophylaxis or therapy.
- Fever before vaccination, axillary temperature 37.0 centigrades.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To evaluate the safety of pandemic inactivated influenza vaccine by different does.
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Secondary Outcome Measures
Outcome Measure |
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To evaluate the immunogenicity of pandemic inactivated influenza vaccine by different does.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jiangtao Lin, MD, China-Japan Friendship Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2005
Study Completion
April 1, 2006
Study Registration Dates
First Submitted
July 25, 2006
First Submitted That Met QC Criteria
July 25, 2006
First Posted (Estimate)
July 26, 2006
Study Record Updates
Last Update Posted (Estimate)
November 9, 2007
Last Update Submitted That Met QC Criteria
November 8, 2007
Last Verified
November 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO-PanFlu-1001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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