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

Phase 1

Completed

• Conditions: Pandemic Influenza Vaccine; Prevention; Pandemic Influenza
• Interventions: Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14)

• Registration Number: NCT00660257
• Lead Sponsor: Sinovac Biotech Co., Ltd

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2007-03
• Study Completion: 2008-03
• Status Verified: 2008-04
• Study First Submitted: 2008-04-15
• Study First Submitted QC: 2008-04-16
• Last Update Submitted: 2008-04-16
• Study First Posted: 2008-04-17
• Last Update Posted: 2008-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No.1: 1.25 ug	pandemic influenza vaccine (H5N1 strain NIBRG-14)	-
No.2: 2.5 ug	pandemic influenza vaccine (H5N1 strain NIBRG-14)	-
No.3: 5.0 ug	pandemic influenza vaccine (H5N1 strain NIBRG-14)	-
No. 4: 10 ug	pandemic influenza vaccine (H5N1 strain NIBRG-14)	-

Primary Outcome Measures

Name	Time	Method
HI antibody Neutralization antibody	15 and 30 days after the booster dose

Secondary Outcome Measures

Name	Time	Method
local adverse reactions systemic adverse reactions temperature	3 days after booster dose

Trial Locations

Locations (1)

China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China