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The Clinical Trial Protocol for the Influenza Virus Vaccine (Split Virion, Inactivated) (Children Forms of Drug)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01551823
Recruitment Status : Completed
First Posted : March 13, 2012
Last Update Posted : August 2, 2016
Sponsor:
Collaborator:
Hebei CDC ,China
Information provided by (Responsible Party):
Guoyang Liao, Chinese Academy of Medical Sciences

Tracking Information
First Submitted Date  ICMJE March 9, 2012
First Posted Date  ICMJE March 13, 2012
Last Update Posted Date August 2, 2016
Study Start Date  ICMJE March 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2012)
To evaluate the safety and the immunogenicity of Influenza Virus Vaccine (Split Virion, Inactivated) (Children Forms of Drug) [ Time Frame: six months ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Clinical Trial Protocol for the Influenza Virus Vaccine (Split Virion, Inactivated) (Children Forms of Drug)
Official Title  ICMJE The Phase Ⅲ Clinical Trial Protocol for the Influenza Virus Vaccine (Split Virion, Inactivated)(Children Forms of Drug)
Brief Summary The purpose of this study is to evaluate the safety and the immunogenicity of Influenza Virus Vaccine (Split Virion, Inactivated)(children forms of drug) that do not contains Preservative.
Detailed Description

Influenza Virus Vaccine (Split Virion, Inactivated) that do not contain Preservative. HA contents 7.5μg/0.5ml per dose include H1N1、H3N2 and B.

Inactivated Split Influenza Vaccine was manufactured by Sanofi Pasteur HA contents 7.5μg/0.5ml per dose include H1N1、H3N2 and B.

This is a randomized, blind phase 3 clinical trial. Total 1200 adults (ages from 6 months to 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 two doses of either Influenza Virus Vaccine (Split Virion, Inactivated) or Sanof IVV respectively,21 days apart.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Influenza
Intervention  ICMJE
  • Biological: Influenza Virus Vaccine(no Preservative )
    Influenza Virus Vaccine(no Preservative) 2×0.25ml intramuscular injections
  • Biological: Influenza Virus Vaccine(contains Preservative)
    Influenza Virus Vaccine(contains Preservative)2×0.25ml intramuscular injections
    Other Name: Vaxigrip
Study Arms  ICMJE
  • Experimental: Team 1
    Influenza Virus Vaccine(no Preservative) 2×0.25ml intramuscular injections
    Intervention: Biological: Influenza Virus Vaccine(no Preservative )
  • Experimental: Team 2
    Influenza Virus Vaccine(contains Preservative)2×0.25ml intramuscular injections
    Intervention: Biological: Influenza Virus Vaccine(contains Preservative)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 9, 2012)
1200
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males and females, age from 6 months to 35 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.

Exclusion Criteria for doses 2

  • Have serious anaphylaxis or high fever, convulsion during first dose;
  • Have any circus of Exclusion Criteria after Eligible for study;
  • Have serious adverse event which related to previous vaccination;
  • Withdrawal and Discontinuance Criteria;
  • Received necessary or interference study drugs such as: immune-inhibition or immune-stimulating agents;
  • Vaccinated with any other vaccine(except DTP);
  • Stop observation determined by investigator owing to occurring serious adverse event.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 35 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01551823
Other Study ID Numbers  ICMJE IMBCAMS-05
2011L01487 ( Other Identifier: China state food and drug adminstration )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Guoyang Liao, Chinese Academy of Medical Sciences
Study Sponsor  ICMJE Chinese Academy of Medical Sciences
Collaborators  ICMJE Hebei CDC ,China
Investigators  ICMJE
Principal Investigator: Guoyang Liao, Ph. D Chinese Academy of Medical Sciences
Principal Investigator: Yuliang Zhao, MD Hubei Provincial Center for Disease Control and Prevention
PRS Account Chinese Academy of Medical Sciences
Verification Date July 2016

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