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

Phase 3

Completed

• Conditions: Influenza
• Interventions: Biological: Influenza Virus Vaccine; Biological: Influenza Virus Vaccine(contains Preservative)

• Registration Number: NCT01551810
• Lead Sponsor: Institute of Medical Biology, Chinese Academy of Medical Sciences

Brief 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 .

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 Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-08
• Study First Submitted QC: 2012-03-09
• Study First Posted: 2012-03-13
• Primary Completion: 2012-05
• Study Completion: 2012-08
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-08
• Last Update Posted: 2023-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Influenza Virus Vaccine	Influenza Virus Vaccine	Influenza Virus Vaccine（no Preservative ) 0.5ml intramuscular injections
Influenza Virus Vaccine(Preservative)	Influenza Virus Vaccine	Influenza Virus Vaccine（add Preservative ) 0.5ml intramuscular injections
Influenza Virus Vaccine	Influenza Virus Vaccine(contains Preservative)	Influenza Virus Vaccine（no Preservative ) 0.5ml intramuscular injections
Influenza Virus Vaccine(Preservative)	Influenza Virus Vaccine(contains Preservative)	Influenza Virus Vaccine（add Preservative ) 0.5ml intramuscular injections

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and the immunogenicity of Influenza Virus Vaccine (Split Virion, Inactivated)	six months

Trial Locations

Locations (1)

Dingxing Center for Disease Prevention and Control; 🇨🇳 Shijiazhuang, Hebei, China