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Randomized, Double Blinded, Placebo Control Clinical Trial of Pandemic Influenza Inactive Vaccine on Healthy Subjects

Primary Purpose

Influenza

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
an inactivated whole virion H5N1 vaccine, adjuvanted
Sponsored by
Sinovac Biotech Co., Ltd
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring pandemic, influenza, H5N1, vaccine

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • China-Japan Friendship Hospital

Outcomes

Primary Outcome Measures

To evaluate the safety of pandemic inactivated influenza vaccine by different does.

Secondary Outcome Measures

To evaluate the immunogenicity of pandemic inactivated influenza vaccine by different does.

Full Information

First Posted
July 25, 2006
Last Updated
November 8, 2007
Sponsor
Sinovac Biotech Co., Ltd
Collaborators
Ministry of Science and Technology of the People´s Republic of China
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1. Study Identification

Unique Protocol Identification Number
NCT00356798
Brief Title
Randomized, Double Blinded, Placebo Control Clinical Trial of Pandemic Influenza Inactive Vaccine on Healthy Subjects
Official Title
The Phase-I Clinical Trial Protocol for the Pandemic Inactivated Influenza Vaccine
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Sinovac Biotech Co., Ltd
Collaborators
Ministry of Science and Technology of the People´s Republic of China

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
pandemic, influenza, H5N1, vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
Double
Allocation
Randomized
Enrollment
120 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
an inactivated whole virion H5N1 vaccine, adjuvanted
Primary Outcome Measure Information:
Title
To evaluate the safety of pandemic inactivated influenza vaccine by different does.
Secondary Outcome Measure Information:
Title
To evaluate the immunogenicity of pandemic inactivated influenza vaccine by different does.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiangtao Lin, MD
Organizational Affiliation
China-Japan Friendship Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
China-Japan Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
16980114
Citation
Lin J, Zhang J, Dong X, Fang H, Chen J, Su N, Gao Q, Zhang Z, Liu Y, Wang Z, Yang M, Sun R, Li C, Lin S, Ji M, Liu Y, Wang X, Wood J, Feng Z, Wang Y, Yin W. Safety and immunogenicity of an inactivated adjuvanted whole-virion influenza A (H5N1) vaccine: a phase I randomised controlled trial. Lancet. 2006 Sep 16;368(9540):991-7. doi: 10.1016/S0140-6736(06)69294-5.
Results Reference
result

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Randomized, Double Blinded, Placebo Control Clinical Trial of Pandemic Influenza Inactive Vaccine on Healthy Subjects

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