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The Clinical Trial Protocol for the Influenza Virus Vaccine (Split Virion, Inactivated) (IVV)

This study has been completed.
Sponsor:
Collaborator:
Hebei CDC ,China
Information provided by (Responsible Party):
Guoyang Liao, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01551810
First received: March 8, 2012
Last updated: July 31, 2016
Last verified: July 2016

March 8, 2012
July 31, 2016
March 2012
May 2012   (final data collection date for primary outcome measure)
To evaluate the safety and the immunogenicity of Influenza Virus Vaccine (Split Virion, Inactivated) [ Time Frame: six months ] [ Designated as safety issue: Yes ]
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Complete list of historical versions of study NCT01551810 on ClinicalTrials.gov Archive Site
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The Clinical Trial Protocol for the Influenza Virus Vaccine (Split Virion, Inactivated)
The Phase Ⅲ Clinical Trial Protocol for the Influenza Virus Vaccine (Split Virion, Inactivated)
The purpose of this study is to evaluate the safety and the immunogenicity of Influenza Virus Vaccine (Split Virion, Inactivated) that do not contains Preservative .

Influenza Virus Vaccine (Split Virion, Inactivated) that do not contains Preservative. HA contents 15μg/0.5ml per dose includ H1N1、H3N2 and B.

Inactivated Split Influenza Vaccine was manufactured by Sanofi Pasteur HA contents 15μg/0.5ml per dose includ H1N1、H3N2 and B.

This is a randomized, blind phase 3 clinical trial. Total 1200 adults (above ages 36 months ) were selected, randomized to two groups [Influenza Virus Vaccine (Split Virion, Inactivated) and Inactivated Split Influenza Vaccine , each group n=600], adults in each group will be vaccinated with one dose of either Influenza Virus Vaccine (Split Virion, Inactivated) or Sanof IVV respectively.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Influenza
  • Biological: Influenza Virus Vaccine
    Influenza Virus Vaccine 0.5ml intramuscular injections
  • Biological: Influenza Virus Vaccine(contains Preservative)
    Influenza Virus Vaccine(contains Preservative)0.5ml intramuscular injections
    Other Name: Vaxigrip
  • Experimental: Influenza Virus Vaccine
    Influenza Virus Vaccine(no Preservative ) 0.5ml intramuscular injections
    Interventions:
    • Biological: Influenza Virus Vaccine
    • Biological: Influenza Virus Vaccine(contains Preservative)
  • Experimental: Influenza Virus Vaccine(Preservative)
    Influenza Virus Vaccine(add Preservative ) 0.5ml intramuscular injections
    Interventions:
    • Biological: Influenza Virus Vaccine
    • Biological: Influenza Virus Vaccine(contains Preservative)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1200
August 2012
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Males and females, age above 36 months ;
  • Adults, parent(s) or guardians are able to understand and sign informed consent for participation;
  • Participants or guardians are able to attend all planned clinical appointment and obey and follow all study instructions;
  • Infants no vaccinated with influenza or other preventive biologicals in recent 7 days;
  • Axillary temperature ≤37℃.

Exclusion Criteria:

  • Have medical record of participants or their family on allergy and egg, convulsion, falling sickness, encephalopathy and psychopathy;
  • Low platelet or bleeding disorder do not allow vaccination into the muscle;
  • Have damaged or lower immunological function;
  • Received blood, plasma or immunoglobulin treatment since birth;
  • Have inborn abnormality, develop obstacles or clinical diagnostic serious chronic ( Down Syndrome, diabetes, sickle cell anemia or neural Guillain-Barre Syndrome );
  • Have or be doubtful of following diseases: respiratory system diseases, acute infection or active chronic, cardiovascular diseases, liver and kidney diseases, skin diseases, HIV.
Both
36 Months and older   (Child, Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01551810
IMBCAMS-04, 2011L01488
Yes
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Guoyang Liao, Chinese Academy of Medical Sciences
Chinese Academy of Medical Sciences
Hebei CDC ,China
Principal Investigator: Guoyang Liao, Ph. D Chinese Academy of Medical Sciences
Principal Investigator: Yuliang Zhao, MD Hubei Provincial Center for Disease Control and Prevention
Chinese Academy of Medical Sciences
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP