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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00660257
Other study ID # PRO-PanFlu-1002
Secondary ID
Status Completed
Phase Phase 1
First received April 15, 2008
Last updated April 16, 2008
Start date January 2007
Est. completion date March 2008

Study information

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

Clinical Trial 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-virion, aluminium-adjuvanted).


Recruitment information / eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention


Intervention

Biological:
pandemic influenza vaccine (H5N1 strain NIBRG-14)
pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 1.25 ug per dose, intramuscular injection
pandemic influenza vaccine (H5N1 strain NIBRG-14)
pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 2.5 ug per dose, intramuscular injection
pandemic influenza vaccine (H5N1 strain NIBRG-14)
pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 5.0 ug per dose, intramuscular injection
pandemic influenza vaccine (H5N1 strain NIBRG-14)
pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 1.25 ug per dose, intramuscular injection

Locations

Country Name City State
China China-Japan Friendship Hospital Beijing Beijing

Sponsors (2)

Lead Sponsor Collaborator
Sinovac Biotech Co., Ltd Centers for Disease Control and Prevention, China

Country where clinical trial is conducted

China, 

Outcome

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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