Immunogenicity and Safety Study of Allantoic Split Inactivated Seasonal Influenza Vaccine (VSI)

Research Institute for Biological Safety Problems

Status and phase: Completed; Phase 2

Conditions: Influenza

Treatments: Biological: Allantoic Split Inactivated Seasonal flu Vaccine; Biological: VAXIGRIP

Study type: Interventional

Funder types: Other

Identifiers

NCT03016143

VSI-II-01/2016

Details and patient eligibility

About

The study is a single centre, phase II, double-blind, randomized, comparative trial that explored the immunogenicity and safety of single dose a allantoic split inactivated seasonal influenza vaccine and VAXIGRIP vacccine in healthy adults the two age groups (in persons 18 to 60 years of age and older than 60 years).

Enrollment: 300 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• volunteers (men and women) aged 18 years and older.
• Literate and willing to provide written informed consent.
• A signed informed consent.

Exclusion criteria

• Available in anamnaze volunteer at any allergic reactions.
• Allergic reactions to chicken proteins, or any preceding vaccination.
• Acute illness with a fever (37.0 C).
• Vaccination against influenza in the 2015/2016 season.
• Current or recent (within two weeks of enrollment) acute respiratory illness with or without fever.
• Hypersensitivity after previous administration of any vaccine.
• History of chronic alcohol abuse and/or illegal drug use.
• Any clinically significant abnormal laboratory finding.
• A positive pregnancy test for all women of childbearing potential.
• Administration of immunosuppressive drugs or other immune modifying drugs within 4 weeks prior to study enrollment.
• Acute or chronic clinically significant pulmonary disease, cardiovascular disease, gastrointestinal disease, liver disease, neurological illness, liver disease, blood disease, skin disorder, endocrine disorder, neurological illness and psychiatric disorder as determined by medical history, physical examination or clinical laboratory screening tests, which in the opinion of the investigator, might interfere with the study objectives.
• History of leukemia or any other blood or solid organ cancer.
• Receipt of antivirals, antibiotics, immunoglobulins or other blood products within 4 weeks prior to study enrollment or planned receipt of such products during the period of subject participation in the study.
• Participation in another clinical trial within the previous three months or planned enrollment in such a trial during the period of this study.
• Subjects who are, in the opinion of the investigator, at significantly increased risk of non-cooperation with requirements of the study protocol.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 4 patient groups

Group #1 (Allantoic Split Inactivated Seasonal flu Vaccine)

Active Comparator group

Description:

100 volunteers aged 18 to 60 years, which introduced the vaccine allantoic split inactivated seasonal influenza

Treatment:

Biological: Allantoic Split Inactivated Seasonal flu Vaccine

Group #2 (Allantoic Split Inactivated Seasonal flu Vaccine)

Active Comparator group

Description:

100 volunteers over the age of 60 years, which introduced the vaccine allantoic split inactivated seasonal influenza

Treatment:

Biological: Allantoic Split Inactivated Seasonal flu Vaccine

Group #3 (Vaccine VAXIGRIP)

Experimental group

Description:

50 volunteers aged 18 to 60 years, which introduced vaccine VAXIGRIP

Treatment:

Biological: VAXIGRIP

Group #4 (Vaccine VAXIGRIP)

Experimental group

Description:

50 volunteers over the age of 60 years, which introduced vaccine VAXIGRIP

Treatment:

Biological: VAXIGRIP