A Clinical Trial of Split-virion Influenza A/H1N1 Vaccines

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sinovac Biotech Co., Ltd
ClinicalTrials.gov Identifier:
NCT01004653
First received: October 29, 2009
Last updated: March 13, 2013
Last verified: March 2013
  Purpose

A single center, Open-Label phase IV clinical trial is to be conducted in healthy elders (equal to or more than 61 years to evaluate the immunogenicity and safety of Sinovac's 15μg H1N1 influenza A Vaccine (Split virion), Inactivated.


Condition Intervention Phase
Influenza
Biological: H1N1 influenza A Vaccine (Split virion), Inactivated
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: An Open-Label Clinical Trial With Split-virion Influenza A/H1N1 Vaccines in Healthy Elders

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Evaluate immunogenicity of split-virion influenza A (H1N1)vaccine in elders [ Time Frame: Sep. 2009- Oct. 2009 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate Safety of split-virion influenza A (H1N1)vaccine in elders [ Time Frame: Sep. 2009- Oct. 2009 ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: September 2009
Study Completion Date: November 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: H1N1 influenza A Vaccine (Split virion), Inactivated
15 μg H1N1 influenza A Vaccine (Split virion), Inactivated
Biological: H1N1 influenza A Vaccine (Split virion), Inactivated
100 elders were assigned to receive one dose of 15μg H1N1 influenza A Vaccine (Split virion), Inactivated

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy male or female aged 60 and older
  2. Be able to show legal identity card for the sake of recruitment
  3. Volunteers are able to understand and sign the informed consent

Exclusion Criteria:

  1. Cases, cured cases and close contact of influenza A (H1N1) virus
  2. Women of pregnancy, lactation or about to be pregnant in 60 days
  3. Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine, such as egg, egg protein, etc
  4. Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
  5. Autoimmune disease or immunodeficiency
  6. Asthma that is unstable or required emergent care, hospitalization or intubation during the past two years or that required the use of oral or intravenous corticosteroids
  7. Diabetes mellitus (type I or II), with the exception of gestational diabetes
  8. History of thyroidectomy or thyroid disease that required medication within the past 12 months
  9. Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years
  10. Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
  11. 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
  12. Seizure disorder other than:

    • Febrile seizures under the age of two years old
    • Seizures secondary to alcohol withdrawal more than 3 years ago, or
    • A singular seizure not requiring treatment within the last 3 years
  13. Asplenia, functional asplenia or any condition resulting in the absence or removal o the spleen
  14. Guillain-Barre Syndrome
  15. Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis)
  16. History of any blood products or seasonal influenza vaccine administration within 3 months before the dosing
  17. Administration of any other investigational research agents within 30 days before the dosing
  18. Administration of any live attenuated vaccine within 30 days before the dosing
  19. Administration of subunit or inactivated vaccines, e.g., pneumococcal vaccine, or allergy treatment with antigen injections, within 14 days before the dosing
  20. Be receiving anti-TB prophylaxis or therapy currently
  21. Axillary temperature > 37.0 centigrade at the time of dosing
  22. 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
    • Suicidal ideation occurring within five years prior to enrollment
  23. 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: NCT01004653

Locations
China
Beijing Centers for Diseases Control and Prevention
Beijing, China, 100013
Sponsors and Collaborators
Sinovac Biotech Co., Ltd
  More Information

No publications provided

Responsible Party: Sinovac Biotech Co., Ltd
ClinicalTrials.gov Identifier: NCT01004653     History of Changes
Other Study ID Numbers: PRO-PanFlu-4001-1
Study First Received: October 29, 2009
Last Updated: March 13, 2013
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 28, 2014