The Clinical Trial Protocol for the Influenza Virus Vacci... | NCT01551823

ID	Type	Description	Link
2011L01487	Other Identifier	China state food and drug adminstration

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2012

Primary Completion Date

May 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Mar 9, 2012

First Submission Date that Met QC Criteria

Mar 9, 2012

First Posted Date

Mar 13, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 8, 2023

Last Update Posted Date

Oct 11, 2023Actual

Name	Class
Hebei Provincial Center for Diseases Control and Prevention	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Team 1	Experimental	Influenza Virus Vaccine(no Preservative) 2×0.25ml intramuscular injections	Biological: Influenza Virus Vaccine(no Preservative )
Team 2	Experimental	Influenza Virus Vaccine(contains Preservative)2×0.25ml intramuscular injections	Biological: Influenza Virus Vaccine(contains Preservative)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Influenza Virus Vaccine(no Preservative )	Biological	Influenza Virus Vaccine(no Preservative) 2×0.25ml intramuscular injections	Team 1

Measure	Description	Time Frame
To evaluate the safety and the immunogenicity of Influenza Virus Vaccine (Split Virion, Inactivated) （Children Forms of Drug）		six months

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

35 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Guoyang Liao, Ph. D	Institute of Medical Biology, Chinese Academy of Medical Sciences	Principal Investigator
Yuliang Zhao, MD	Hubei Provincial Center for Disease Control and Prevention	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dingxing Center for Disease Prevention and Control		Shijiazhuang	Hebei		China

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D012140	Respiratory Tract Diseases