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NCT01551810 Clinical Trial

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

Influenza Clinical Trial

— IVV  

Official title:
The Phase Ⅲ Clinical Trial Protocol for the Influenza Virus Vaccine (Split Virion, Inactivated)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01551810
Other study ID # IMBCAMS-04
Secondary ID 2011L01488
Status Completed
Phase Phase 3
First received
Last updated
Start date March 2012
Est. completion date August 2012

Study information
Verified date October 2023
Source Institute of Medical Biology, Chinese Academy of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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 .

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.

Recruitment information / eligibility
Status Completed
Enrollment 1200
Est. completion date August 2012
Est. primary completion date May 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 36 Months and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Biological:
• Influenza Virus Vaccine
Influenza Virus Vaccine 0.5ml intramuscular injections
• Influenza Virus Vaccine(contains Preservative)
Influenza Virus Vaccine(contains Preservative)0.5ml intramuscular injections

Locations
Country Name City State
China Dingxing Center for Disease Prevention and Control Shijiazhuang Hebei

Sponsors (2)
Lead Sponsor Collaborator
Institute of Medical Biology, Chinese Academy of Medical Sciences Hebei Center for Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate the safety and the immunogenicity of Influenza Virus Vaccine (Split Virion, Inactivated) six months
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