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

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ClinicalTrials.gov Identifier: NCT00660257
Recruitment Status : Completed
First Posted : April 17, 2008
Last Update Posted : April 17, 2008
Sponsor:
Collaborator:
Centers for Disease Control and Prevention, China
Information provided by:
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).

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

Study Type : Interventional  (Clinical Trial)
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 : January 2007
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. HI antibody Neutralization antibody [ Time Frame: 15 and 30 days after the booster dose ]

Secondary Outcome Measures :
  1. local adverse reactions systemic adverse reactions temperature [ Time Frame: 3 days after booster dose ]


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Ages Eligible for Study:   19 Years to 61 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: April 17, 2008    Key Record Dates
Last Update Posted: April 17, 2008
Last Verified: April 2008

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs