A Clinical Trial With Influenza A/H1N1 Vaccines

This study has been completed.
Sponsor:
Information provided by:
Sinovac Biotech Co., Ltd
ClinicalTrials.gov Identifier:
NCT00956111
First received: August 10, 2009
Last updated: October 28, 2009
Last verified: October 2009
  Purpose

A single center, stratified, randomized and double-blind phase IV clinical trial is to be conducted in healthy elders (equal to or more than 61 years), adults (18-60 years), adolescents (12-17 years) and children (3-11 years) to evaluate the safety and immunogenicity of Sinovac's split-virion or whole-virion novel influenza A (H1N1) vaccines.


Condition Intervention Phase
Influenza
Biological: split-virion, adjuvanted H1N1 vaccine of 7.5 μg per dose
Biological: split-virion, adjuvanted H1N1 vaccine of 15 μg per dose
Biological: split-virion, non-adjuvanted H1N1 vaccine of 15 μg per dose
Biological: split-virion, non-adjuvanted H1N1 vaccine of 30 μg per dose
Biological: whole-virion, adjuvanted H1N1 vaccine of 5 μg per dose
Biological: whole-virion, adjuvanted H1N1 vaccine of 10 μg per dose
Biological: placebo control
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Double-blind, Randomized, Stratified and Controlled Clinical Trial With Split-virion and Whole-virion, Adjuvanted and Non-adjuvanted Influenza A/H1N1 Vaccines in Healthy Adults, Elders, Adolescents and Children

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Evaluate immunogenicity and safety of influenza A (H1N1)vaccines in elders, adults, adolescent and children . [ Time Frame: July 2009- Sept. 2009 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Provide a basis to determine the best type and dose of vaccine and immunization procedures [ Time Frame: July 2009- Sept. 2009 ] [ Designated as safety issue: No ]

Enrollment: 1614
Study Start Date: July 2009
Study Completion Date: October 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: split-virion, adjuvanted H1N1 vaccine of 7.5 μg
300 participants (100 adults, 100 adolescents and 100 children) to receive split-virion, adjuvanted H1N1 vaccine of 7.5 μg on day 0 and 21.
Biological: split-virion, adjuvanted H1N1 vaccine of 7.5 μg per dose
100 adults, 100 adolescents and 100 children were assigned to receive 2 doses of 7.5μg split-virion, adjuvanted H1N1 vaccine 21 days apart.
Experimental: split-virion, adjuvanted H1N1 vaccine of 15 μg
300 participants (100 adults, 100 adolescents and 100 children) to receive split-virion, adjuvanted H1N1 vaccine of 15 μg on day 0 and 21.
Biological: split-virion, adjuvanted H1N1 vaccine of 15 μg per dose
100 adults, 100 adolescents and 100 children were assigned to receive 2 doses of 15μg split-virion, adjuvanted H1N1 vaccine 21 days apart.
Experimental: split-virion, non-adjuvanted H1N1 vaccine of 15 μg
300 participants (100 adults, 100 adolescents and 100 children) to receive split-virion, non-adjuvanted H1N1 vaccine of 15 μg on day 0 and 21.
Biological: split-virion, non-adjuvanted H1N1 vaccine of 15 μg per dose
100 adults, 100 adolescents and 100 children were assigned to receive 2 doses of 15μg split-virion, non-adjuvanted H1N1 vaccine 21 days apart.
Experimental: split-virion, non-adjuvanted H1N1 vaccine of 30 μg
300 participants (100 adults, 100 adolescents and 100 children) to receive split-virion, non-adjuvanted H1N1 vaccine of 30 μg on day 0 and 21.
Biological: split-virion, non-adjuvanted H1N1 vaccine of 30 μg per dose
100 adults, 100 adolescents and 100 children were assigned to receive 2 doses of 30μg split-virion, non-adjuvanted H1N1 vaccine 21 days apart.
Experimental: whole-virion, adjuvanted H1N1 vaccine of 5 μg
100 adults to receive whole-virion, adjuvanted H1N1 vaccine of 5 μg on day 0 and 21.
Biological: whole-virion, adjuvanted H1N1 vaccine of 5 μg per dose
100 adults were assigned to receive 2 doses of 5μg whole-virion, adjuvanted H1N1 vaccine 21 days apart.
Experimental: whole-virion, adjuvanted H1N1 vaccine of 10 μg

200 participants: 100 adults to receive whole-virion, adjuvanted H1N1 vaccine of 10 μg on day 0 and 21.

100 elders to receive whole-virion, adjuvanted H1N1 vaccine of 10 μg on day 0 only.

Biological: whole-virion, adjuvanted H1N1 vaccine of 10 μg per dose
100 adults were assigned to receive 2 doses of 10μg whole-virion, adjuvanted H1N1 vaccine 21 days apart. 100 elders were assigned to receive 1 doses of 10μg whole-virion, adjuvanted H1N1 vaccine
Placebo Comparator: Placebo control
100 adults to receive placebo control (Phosphate Buffer Saline) on day 0 and 21.
Biological: placebo control
100 adults were assigned to receive 2 doses of placebo 21 days apart.

  Eligibility

Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy male or female aged 3 and older
  2. Be able to show legal identity card for the sake of recruitment
  3. Volunteers or their guardians 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: NCT00956111

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

No publications provided by Sinovac Biotech Co., Ltd

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wei-Dong Yin, Sinovac Biotech Co., Ltd
ClinicalTrials.gov Identifier: NCT00956111     History of Changes
Other Study ID Numbers: PRO-PanFlu-4001
Study First Received: August 10, 2009
Last Updated: October 28, 2009
Health Authority: China: Food and Drug Administration

Keywords provided by Sinovac Biotech Co., Ltd:
Novel Influenza A/H1N1 Vaccine
Immunogenictiy
Safety

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 July 24, 2014