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

NCT ID: NCT01551823

Last Updated: 2023-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2012-08-31

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.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Team 1

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

Group Type: EXPERIMENTAL

Influenza Virus Vaccine(no Preservative )

Intervention Type: BIOLOGICAL

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

Team 2

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

Group Type: EXPERIMENTAL

Influenza Virus Vaccine(contains Preservative)

Intervention Type: BIOLOGICAL

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

Interventions

Influenza Virus Vaccine(no Preservative )

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

Intervention Type: BIOLOGICAL

Influenza Virus Vaccine(contains Preservative)

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

Intervention Type: BIOLOGICAL

Other Intervention Names

Vaxigrip

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.

• Have serious anaphylaxis or high fever, convulsion during first dose;
• 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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 35 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hebei Center for Disease Control and Prevention

UNKNOWN

Sponsor Role: collaborator

Institute of Medical Biology, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Guoyang Liao, Ph. D

Role: PRINCIPAL_INVESTIGATOR

Institute of Medical Biology, Chinese Academy of Medical Sciences

Yuliang Zhao, MD

Role: PRINCIPAL_INVESTIGATOR

Hubei Provincial Center for Disease Control and Prevention

Locations

Dingxing Center for Disease Prevention and Control

Shijiazhuang, Hebei, China

Countries

China

Other Identifiers

2011L01487

Identifier Type: OTHER

Identifier Source: secondary_id

IMBCAMS-05

Identifier Type: -

Identifier Source: org_study_id