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

• Sponsor: Sinovac Biotech Co., Ltd (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00660257
• Collaborator: Centers for Disease Control and Prevention, China (Other)
• Enrollment: 57
• Location: 1
• Arms: 4
• Duration (Months): 14
• Patients Per Site Per Month: 4.1

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Pandemic Influenza Vaccine; Prevention; Pandemic Influenza	Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14); Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14); Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14); Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14)	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 57 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• 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
• Study Start Date: Jan 1, 2007
• Actual Primary Completion Date: Mar 1, 2007
• Actual Study Completion Date: Mar 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: No.1: 1.25 ug	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
Experimental: No.2: 2.5 ug	Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14); pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 2.5 ug per dose, intramuscular injection
Experimental: No.3: 5.0 ug	Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14); pandemic influenza vaccine (H5N1 strain NIBRG-14) booster (third) dose: 5.0 ug per dose, intramuscular injection
Experimental: No. 4: 10 ug	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

Outcome Measures

Primary Outcome Measures

1. HI antibody Neutralization antibody [15 and 30 days after the booster dose]

Secondary Outcome Measures

1. local adverse reactions systemic adverse reactions temperature [3 days after booster dose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 61 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	China-Japan Friendship Hospital	Beijing	Beijing	China

Sponsors and Collaborators

• Sinovac Biotech Co., Ltd
• Centers for Disease Control and Prevention, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00660257
• Other Study ID Numbers: PRO-PanFlu-1002
• First Posted: Apr 17, 2008
• Last Update Posted: Apr 17, 2008
• Last Verified: Apr 1, 2008

• Additional relevant MeSH terms: Influenza, Human; Vaccines

Study Results

No Results Posted as of Apr 17, 2008