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

This study has been completed.
Sponsor:
Collaborator:
Centers for Disease Control and Prevention, China
Information provided by:
Sinovac Biotech Co., Ltd
ClinicalTrials.gov Identifier:
NCT00660257
First received: April 15, 2008
Last updated: April 16, 2008
Last verified: April 2008
  Purpose

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 Intervention Phase
Pandemic Influenza Vaccine
Prevention
Pandemic Influenza
Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Sinovac Biotech Co., Ltd:

Primary Outcome Measures:
  • HI antibody Neutralization antibody [ Time Frame: 15 and 30 days after the booster dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • local adverse reactions systemic adverse reactions temperature [ Time Frame: 3 days after booster dose ] [ Designated as safety issue: Yes ]

Enrollment: 57
Study Start Date: January 2007
Study Completion Date: March 2008
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   19 Years to 61 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00660257

Locations
China, Beijing
China-Japan Friendship Hospital
Beijing, Beijing, China
Sponsors and Collaborators
Sinovac Biotech Co., Ltd
Centers for Disease Control and Prevention, China
  More Information

No publications provided by Sinovac Biotech Co., Ltd

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00660257     History of Changes
Other Study ID Numbers: PRO-PanFlu-1002
Study First Received: April 15, 2008
Last Updated: April 16, 2008
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014