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

Institute of Medical Biology, Chinese Academy of Medical Sciences

Status and phase: Completed; Phase 3

Conditions: Influenza

Treatments: Biological: Influenza Virus Vaccine; Biological: Influenza Virus Vaccine(contains Preservative)

Study type: Interventional

Funder types: Other

Identifiers

NCT01551810

2011L01488 (Other Identifier)

IMBCAMS-04

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 1,200 patients

Sex: All

Ages: 36+ months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,200 participants in 2 patient groups

Influenza Virus Vaccine

Experimental group

Description:

Influenza Virus Vaccine（no Preservative ) 0.5ml intramuscular injections

Treatment:

Biological: Influenza Virus Vaccine

Biological: Influenza Virus Vaccine(contains Preservative)

Influenza Virus Vaccine(Preservative)

Experimental group

Description:

Influenza Virus Vaccine（add Preservative ) 0.5ml intramuscular injections

Treatment:

Biological: Influenza Virus Vaccine

Biological: Influenza Virus Vaccine(contains Preservative)