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

This study is currently recruiting participants.
Verified March 2012 by Chinese Academy of Medical Sciences
Sponsor:
Collaborators:
Hebei province Center for Disease Prevention and Control
National Institute for the Control of Pharmaceutical and Biological Products, China
Information provided by (Responsible Party):
Guoyang Liao, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01551810
First received: March 8, 2012
Last updated: March 13, 2012
Last verified: March 2012
History of Changes

March 8, 2012
March 13, 2012
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 ]
Not Provided
Complete list of historical versions of study NCT01551810 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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 (no Preservative )
    Influenza Virus Vaccine(no Preservative) 0.5ml intramuscular injections
  • Biological: Influenza Virus Vaccine(contains Preservative)
    Influenza Virus Vaccine(contains Preservative)0.5ml intramuscular injections
    Other Name: Vaxigrip
  • Experimental: Team 1
    Influenza Virus Vaccine（no Preservative ) 0.5ml intramuscular injections
    Intervention: Biological: Influenza Virus Vaccine (no Preservative )
  • Experimental: Team 2
    Influenza Virus Vaccine(contains Preservative)0.5ml intramuscular injections
    Intervention: Biological: Influenza Virus Vaccine(contains Preservative)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
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
Yes
Contact: Guoyang Liao, Ph D 86-0871-8334330 liaogy@imbcams.com.cn
Contact: Yuliang Zhao, MD 86-0311-86573212 yuliangzhao@yahoo.com.cn
China
 
NCT01551810
IMBCAMS-04, 2011L01488
Yes
Guoyang Liao, Chinese Academy of Medical Sciences
Chinese Academy of Medical Sciences
  • Hebei province Center for Disease Prevention and Control
  • National Institute for the Control of Pharmaceutical and Biological Products, China
Principal Investigator: Guoyang Liao, Ph. D Institute of Medical Biology, Chinese Academy of Medical Sciences
Principal Investigator: Yuliang Zhao, MD Hebei province Center for Disease Prevention and Control
Chinese Academy of Medical Sciences
March 2012

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