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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
  Purpose
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 .

Condition Intervention Phase
Influenza
Biological: Influenza Virus Vaccine
Biological: Influenza Virus Vaccine(contains Preservative)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Phase Ⅲ Clinical Trial Protocol for the Influenza Virus Vaccine (Split Virion, Inactivated)

Resource links provided by NLM:


Further study details as provided by Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • To evaluate the safety and the immunogenicity of Influenza Virus Vaccine (Split Virion, Inactivated) [ Time Frame: six months ] [ Designated as safety issue: Yes ]

Enrollment: 1200
Study Start Date: March 2012
Study Completion Date: August 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Influenza Virus Vaccine
Influenza Virus Vaccine(no Preservative ) 0.5ml intramuscular injections
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(Preservative)
Influenza Virus Vaccine(add Preservative ) 0.5ml intramuscular injections
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   36 Months and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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: NCT01551810

Locations
China, Hebei
Dingxing Center for Disease Prevention and Control
Shijiazhuang, Hebei, China
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Hebei CDC ,China
Investigators
Principal Investigator: Guoyang Liao, Ph. D Chinese Academy of Medical Sciences
Principal Investigator: Yuliang Zhao, MD Hubei Provincial Center for Disease Control and Prevention
  More Information

Responsible Party: Guoyang Liao, Head of Biologicals No.15, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01551810     History of Changes
Other Study ID Numbers: IMBCAMS-04  2011L01488 
Study First Received: March 8, 2012
Last Updated: July 31, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Chinese Academy of Medical Sciences:
Influenza Virus Vaccine (Split Virion, Inactivated)
Influenza

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 06, 2016