Safety and Immunogenicity of Booster Dose of An Inactivated,Adjuvanted Whole-Virion Pandemic Influenza(H5N1)Vaccine

Prevention Clinical Trial

Official title:

Safety and Immunogenicity of Booster Dose of An Inactivated,Adjuvanted Whole-Virion Pandemic Influenza (H5N1)Vaccine in Two-Dose Primed Healthy Adults: A Single Center, Non-Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00660257
• Other study ID #: PRO-PanFlu-1002
• 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

Related Conditions & MeSH terms

• Influenza, Human
• Pandemic Influenza
• Pandemic Influenza Vaccine
• 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