The Long-term Immunogenicity of an Inactivated Split-virion 2009 Pandemic Influenza A H1N1 Vaccine

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Shanghai Institute Of Biological Products.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Shanghai Institute Of Biological Products
ClinicalTrials.gov Identifier:
NCT01336166
First received: April 7, 2011
Last updated: April 14, 2011
Last verified: April 2011
  Purpose

The aim of this study is to investigate the long-term immunogenicity and safety of the inactivated split-virion vaccine after one immunization.


Condition Intervention Phase
Influenza
Biological: split-virion, non-adjuvanted H1N1 vaccine of 15 μg
Biological: split-virion, non-adjuvanted H1N1 vaccine of 30 μg
Biological: split-virion, non-adjuvanted H1N1 vaccine of 45 μg
Biological: Placebo control
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Shanghai Institute Of Biological Products:

Primary Outcome Measures:
  • Hemagglutination inhibition antibody titer [ Time Frame: Day 180 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • occurrence of solicited local and systemic adverse events after vaccination [ Time Frame: Days 0-42 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 480
Study Start Date: July 2009
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: split-virion, non-adjuvanted vaccine of 15 μg
split-virion, non-adjuvanted H1N1 vaccine of 15 μg.
Biological: split-virion, non-adjuvanted H1N1 vaccine of 15 μg
120 adults were assigned to receive 1 dose of 15μg split-virion, non-adjuvanted H1N1 vaccine.
Experimental: split-virion, non-adjuvanted vaccine of 30 μg
split-virion, non-adjuvanted H1N1 vaccine of 30 μg.
Biological: split-virion, non-adjuvanted H1N1 vaccine of 30 μg
120 adults were assigned to receive 1 dose of 30μg split-virion, non-adjuvanted H1N1 vaccine.
Experimental: split-virion, non-adjuvanted vaccine of 45 μg
split-virion, non-adjuvanted H1N1 vaccine of 45 μg.
Biological: split-virion, non-adjuvanted H1N1 vaccine of 45 μg
120 adults were assigned to receive 1 dose of 45μg split-virion, non-adjuvanted H1N1 vaccine.
Placebo Comparator: Placebo control
Placebo control
Biological: Placebo control
120 adults were assigned to receive 1 dose of placebo.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Different age groups from 18 to 60 years, with normal intelligence and health. Volunteers (or their guardians) are well informed of the situation and sign the consent
  2. Vaccination recipients qualified for this product have been inquired about medical history and clinically proven to be healthy
  3. Requests of clinical research program can be obeyed
  4. No other protective product is inoculated in last week
  5. Axillary temperature below 37 degrees Celsius

Exclusion Criteria:

  1. Volunteers in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination
  2. Volunteers allergic to ingredient of vaccine composition (can be checked from vaccination history), especially to egg
  3. History of progressive or severe neurologic disorder
  4. Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
  5. Known or suspected impairment/alteration of immune function, for example receiving immunosuppressive therapy or receiving blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation
  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. 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
  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. Guillain-Barre Syndrome
  11. Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C
  12. Any other vaccines or immunoglobulin preparation within 1 weeks prior to enrollment
  13. Axillary temperature ≥ 38.0 degrees Celsius within 3 days of intended study vaccination
  14. Any conditions may influence the evaluation
  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: NCT01336166

Locations
China, Hunan
Hunan Provincial Center of Disease Prevention and Control
Changsha, Hunan, China, 410005
Sponsors and Collaborators
Shanghai Institute Of Biological Products
  More Information

No publications provided

Responsible Party: Ze Chen, Shanghai Institute of Biological Products
ClinicalTrials.gov Identifier: NCT01336166     History of Changes
Other Study ID Numbers: SIBP-2009
Study First Received: April 7, 2011
Last Updated: April 14, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Shanghai Institute Of Biological Products:
H1N1
Vaccine
Immunogenicity
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 August 28, 2014