- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03016143
Immunogenicity and Safety Study of Allantoic Split Inactivated Seasonal Influenza Vaccine (VSI)
June 6, 2018 updated by: Research Institute for Biological Safety Problems
A Randomized, Blinded, Comparative Study of Phase II Allantoic Split Inactivated Seasonal Influenza Vaccine in Healthy Adults
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
300
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Almaty, Kazakhstan, 050000
- Kazakh National Medical University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Group #1 (Allantoic Split Inactivated Seasonal flu Vaccine)
100 volunteers aged 18 to 60 years, which introduced the vaccine allantoic split inactivated seasonal influenza
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Allantoic split inactivated seasonal influenza vaccine has been prepared on eggs and is made from inactivated parts of the following influenza virus strains: NIBRG-121xp (A/California/7/2009 (H1N1)v and А/PR/8/34 (H1N1)), NYMC X-217 (A/ Victoria/361/2011(H3N2) and А/PR/8/34 (H1N1)), NYMC BX-49 (B/Texas/06/2011 (Yamagata lineage) - like High Yield Reassortant (1:1:6) With B/Lee/40 NP, B/Panama/45/90 NS genes).
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Active Comparator: Group #2 (Allantoic Split Inactivated Seasonal flu Vaccine)
100 volunteers over the age of 60 years, which introduced the vaccine allantoic split inactivated seasonal influenza
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Allantoic split inactivated seasonal influenza vaccine has been prepared on eggs and is made from inactivated parts of the following influenza virus strains: NIBRG-121xp (A/California/7/2009 (H1N1)v and А/PR/8/34 (H1N1)), NYMC X-217 (A/ Victoria/361/2011(H3N2) and А/PR/8/34 (H1N1)), NYMC BX-49 (B/Texas/06/2011 (Yamagata lineage) - like High Yield Reassortant (1:1:6) With B/Lee/40 NP, B/Panama/45/90 NS genes).
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Experimental: Group #3 (Vaccine VAXIGRIP)
50 volunteers aged 18 to 60 years, which introduced vaccine VAXIGRIP
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Vaxigrip - Seasonal Influenza, split virion, inactivated vaccine.
Sanofi Pasteur Serial Number N3E681V
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Experimental: Group #4 (Vaccine VAXIGRIP)
50 volunteers over the age of 60 years, which introduced vaccine VAXIGRIP
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Vaxigrip - Seasonal Influenza, split virion, inactivated vaccine.
Sanofi Pasteur Serial Number N3E681V
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Geometric Mean Fold Increase in HI Antibody Titer
Time Frame: Change from Baseline HI Antibody Titer at 21 days
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Geometric mean fold increase in HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination, as compared with Baseline.
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Change from Baseline HI Antibody Titer at 21 days
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Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer
Time Frame: Change from Baseline HI Antibody Titer at 21 days
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Seroconversion rate was measured by hemagglutination inhibition (HI) antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination.
Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from the Baseline HI antibody titer in participants with a Baseline titer ≥10, or achieving an HI antibody titer of ≥40 in participants with a Baseline titer <10.
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Change from Baseline HI Antibody Titer at 21 days
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Seroprotection Rate of HI Antibody Titer
Time Frame: Change from Baseline HI Antibody Titer at 21 days
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Seroprotection rate, defined as the percentage of participants with HI antibody titer of ≥40, was measured by HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination.
Day 1 data is reported for reference.
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Change from Baseline HI Antibody Titer at 21 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs)
Time Frame: 21 Days
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Participants recorded solicited injection site and systemic adverse events in a Subject Diary.
Solicited Locals AEs were: Injection Site Pain, Injection Site Redness, Injection Site Swelling, Injection Site Induration and Injection Site Ecchymosis.
Solicited Systemic AEs were: Pyrexia, Malaise, Chills, Fatigue, Headache, Sweaty, Myalgia, Arthralgia, Nausea and Vomiting.
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21 Days
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Percentage of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)
Time Frame: 21 Days
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Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product.
TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
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21 Days
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Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs
Time Frame: 21 Days
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The percentage of participants with any abnormal standard safety laboratory values (Chemistry, Hematology and Urinalysis) collected throughout the study reported as AEs.
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21 Days
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Serious adverse events (SAEs), including abnormal laboratory findings
Time Frame: 21 Days
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Serious adverse events (SAEs) are medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
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21 Days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Berik M Khairullin, PhD, Research Institute for Biological Safety Problems
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2016
Primary Completion (Actual)
November 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
January 4, 2017
First Submitted That Met QC Criteria
January 8, 2017
First Posted (Estimate)
January 10, 2017
Study Record Updates
Last Update Posted (Actual)
June 7, 2018
Last Update Submitted That Met QC Criteria
June 6, 2018
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VSI-II-01/2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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