- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01551810
The Clinical Trial Protocol for the Influenza Virus Vaccine (Split Virion, Inactivated) (IVV)
The Phase Ⅲ Clinical Trial Protocol for the Influenza Virus Vaccine (Split Virion, Inactivated)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Hebei
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Shijiazhuang, Hebei, China
- Dingxing Center for Disease Prevention and Control
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Influenza Virus Vaccine
Influenza Virus Vaccine(no Preservative ) 0.5ml intramuscular injections
|
Influenza Virus Vaccine 0.5ml intramuscular injections
Influenza Virus Vaccine(contains Preservative)0.5ml
intramuscular injections
Other Names:
|
Experimental: Influenza Virus Vaccine(Preservative)
Influenza Virus Vaccine(add Preservative ) 0.5ml intramuscular injections
|
Influenza Virus Vaccine 0.5ml intramuscular injections
Influenza Virus Vaccine(contains Preservative)0.5ml
intramuscular injections
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the safety and the immunogenicity of Influenza Virus Vaccine (Split Virion, Inactivated)
Time Frame: six months
|
six months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Yuliang Zhao, MD, Hubei Provincial Center for Disease Control and Prevention
- Principal Investigator: Guoyang Liao, Ph. D, Institute of Medical Biology, Chinese Academy of Medical Sciences
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IMBCAMS-04
- 2011L01488 (Other Identifier: China state food and drug adminstration)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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