Clinical trial NCT03016143: Immunogenicity and Safety Study of Allantoic Split Inactivated Seasonal Influenza Vaccine (VSI)
Official title: A Randomized, Blinded, Comparative Study of Phase II Allantoic Split Inactivated Seasonal Influenza Vaccine in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: phase II
split
vaccine
Lead sponsor: Research Institute for Biological Safety Problems
Sponsor class: OTHER_GOV
Collaborators: name: Asfendiyarov Kazakh National Medical University
name: Research Institute of Influenza, Russia
First posted: 2017-01-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Geometric Mean Fold Increase in HI Antibody Titer
timeFrame: Change from Baseline HI Antibody Titer at 21 days
measure: Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer
timeFrame: Change from Baseline HI Antibody Titer at 21 days
measure: Seroprotection Rate of HI Antibody Titer
timeFrame: Change from Baseline HI Antibody Titer at 21 days
Secondary outcomes:
measure: Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs)
timeFrame: 21 Days
measure: Percentage of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)
timeFrame: 21 Days
measure: Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs
timeFrame: 21 Days
measure: Serious adverse events (SAEs), including abnormal laboratory findings
timeFrame: 21 Days
Other outcomes:
Locations:
city: Almaty
country: Kazakhstan
facility: Kazakh National Medical University
Study officials:
affiliation: Research Institute for Biological Safety Problems
name: Berik M Khairullin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sarsenbayeva G, Issagulov T, Kassenov M, Abitay R, Orynbayev M, Stukova M, Pisareva M, Davlyatshin T, Lespek K, Khairullin B. Safety and immunogenicity of trivalent inactivated influenza vaccine in adults 60 years of age and older: a phase II, a randomized, comparative trial in Kazakhstan. Hum Vaccin Immunother. 2020 Aug 2;16(8):1791-1797. doi: 10.1080/21645515.2019.1705691. Epub 2020 Feb 12.