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

Primary Purpose

Influenza

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Influenza Virus Vaccine(no Preservative )
Influenza Virus Vaccine(contains Preservative)
Sponsored by
Institute of Medical Biology, Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza Virus Vaccine (Split Virion, Inactivated), Influenza

Eligibility Criteria

6 Months - 35 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Dingxing Center for Disease Prevention and Control

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Team 1

Team 2

Arm Description

Influenza Virus Vaccine(no Preservative) 2×0.25ml intramuscular injections

Influenza Virus Vaccine(contains Preservative)2×0.25ml intramuscular injections

Outcomes

Primary Outcome Measures

To evaluate the safety and the immunogenicity of Influenza Virus Vaccine (Split Virion, Inactivated) （Children Forms of Drug）

Secondary Outcome Measures

Full Information

First Posted
March 9, 2012
Last Updated
October 8, 2023
Sponsor
Institute of Medical Biology, Chinese Academy of Medical Sciences
Collaborators
Hebei Center for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT01551823
Brief Title
The Clinical Trial Protocol for the Influenza Virus Vaccine (Split Virion, Inactivated) （Children Forms of Drug）
Official Title
The Phase Ⅲ Clinical Trial Protocol for the Influenza Virus Vaccine (Split Virion, Inactivated)（Children Forms of Drug）
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Medical Biology, Chinese Academy of Medical Sciences
Collaborators
Hebei Center for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza Virus Vaccine (Split Virion, Inactivated), Influenza

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Team 1
Arm Type
Experimental
Arm Description
Influenza Virus Vaccine(no Preservative) 2×0.25ml intramuscular injections
Arm Title
Team 2
Arm Type
Experimental
Arm Description
Influenza Virus Vaccine(contains Preservative)2×0.25ml intramuscular injections
Intervention Type
Biological
Intervention Name(s)
Influenza Virus Vaccine(no Preservative )
Intervention Description
Influenza Virus Vaccine(no Preservative) 2×0.25ml intramuscular injections
Intervention Type
Biological
Intervention Name(s)
Influenza Virus Vaccine(contains Preservative)
Other Intervention Name(s)
Vaxigrip
Intervention Description
Influenza Virus Vaccine(contains Preservative)2×0.25ml intramuscular injections
Primary Outcome Measure Information:
Title
To evaluate the safety and the immunogenicity of Influenza Virus Vaccine (Split Virion, Inactivated) （Children Forms of Drug）
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
35 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guoyang Liao, Ph. D
Organizational Affiliation
Institute of Medical Biology, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yuliang Zhao, MD
Organizational Affiliation
Hubei Provincial Center for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dingxing Center for Disease Prevention and Control
City
Shijiazhuang
State/Province
Hebei
Country
China

12. IPD Sharing Statement

Links:
URL
http://imbcams.ac.cn/Index.html
Description
Home page of Institute of Medical Biology, Chinese Academy of Medical Sciences

Learn more about this trial

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

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