Clinical trial NCT00356798: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Influenza
Keywords: pandemic
influenza
H5N1
vaccine
Lead sponsor: Sinovac Biotech Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Ministry of Science and Technology of the People´s Republic of China
First posted: 2006-07-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: To evaluate the safety of pandemic inactivated influenza vaccine by different does.
Secondary outcomes:
measure: To evaluate the immunogenicity of pandemic inactivated influenza vaccine by different does.
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
Study officials:
affiliation: China-Japan Friendship Hospital
name: Jiangtao Lin, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.