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

Primary Purpose

Influenza

Status
Completed
Phase
Phase 2
Locations
Kazakhstan
Study Type
Interventional
Intervention
Allantoic Split Inactivated Seasonal flu Vaccine
VAXIGRIP
Sponsored by
Research Institute for Biological Safety Problems
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring phase II, split, vaccine

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Kazakh National Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Experimental

Experimental

Arm Label

Group #1 (Allantoic Split Inactivated Seasonal flu Vaccine)

Group #2 (Allantoic Split Inactivated Seasonal flu Vaccine)

Group #3 (Vaccine VAXIGRIP)

Group #4 (Vaccine VAXIGRIP)

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Geometric Mean Fold Increase in HI Antibody Titer
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.
Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer
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.
Seroprotection Rate of HI Antibody Titer
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.

Secondary Outcome Measures

Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs)
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.
Percentage of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)
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.
Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs
The percentage of participants with any abnormal standard safety laboratory values (Chemistry, Hematology and Urinalysis) collected throughout the study reported as AEs.
Serious adverse events (SAEs), including abnormal laboratory findings
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.

Full Information

First Posted
January 4, 2017
Last Updated
June 6, 2018
Sponsor
Research Institute for Biological Safety Problems
Collaborators
Asfendiyarov Kazakh National Medical University, Research Institute of Influenza, Russia
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1. Study Identification

Unique Protocol Identification Number
NCT03016143
Brief Title
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

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Research Institute for Biological Safety Problems
Collaborators
Asfendiyarov Kazakh National Medical University, Research Institute of Influenza, Russia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
phase II, split, vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group #1 (Allantoic Split Inactivated Seasonal flu Vaccine)
Arm Type
Active Comparator
Arm Description
100 volunteers aged 18 to 60 years, which introduced the vaccine allantoic split inactivated seasonal influenza
Arm Title
Group #2 (Allantoic Split Inactivated Seasonal flu Vaccine)
Arm Type
Active Comparator
Arm Description
100 volunteers over the age of 60 years, which introduced the vaccine allantoic split inactivated seasonal influenza
Arm Title
Group #3 (Vaccine VAXIGRIP)
Arm Type
Experimental
Arm Description
50 volunteers aged 18 to 60 years, which introduced vaccine VAXIGRIP
Arm Title
Group #4 (Vaccine VAXIGRIP)
Arm Type
Experimental
Arm Description
50 volunteers over the age of 60 years, which introduced vaccine VAXIGRIP
Intervention Type
Biological
Intervention Name(s)
Allantoic Split Inactivated Seasonal flu Vaccine
Intervention Description
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).
Intervention Type
Biological
Intervention Name(s)
VAXIGRIP
Intervention Description
Vaxigrip - Seasonal Influenza, split virion, inactivated vaccine. Sanofi Pasteur Serial Number N3E681V
Primary Outcome Measure Information:
Title
Geometric Mean Fold Increase in HI Antibody Titer
Description
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.
Time Frame
Change from Baseline HI Antibody Titer at 21 days
Title
Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer
Description
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.
Time Frame
Change from Baseline HI Antibody Titer at 21 days
Title
Seroprotection Rate of HI Antibody Titer
Description
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.
Time Frame
Change from Baseline HI Antibody Titer at 21 days
Secondary Outcome Measure Information:
Title
Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs)
Description
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.
Time Frame
21 Days
Title
Percentage of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)
Description
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.
Time Frame
21 Days
Title
Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs
Description
The percentage of participants with any abnormal standard safety laboratory values (Chemistry, Hematology and Urinalysis) collected throughout the study reported as AEs.
Time Frame
21 Days
Title
Serious adverse events (SAEs), including abnormal laboratory findings
Description
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.
Time Frame
21 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berik M Khairullin, PhD
Organizational Affiliation
Research Institute for Biological Safety Problems
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kazakh National Medical University
City
Almaty
ZIP/Postal Code
050000
Country
Kazakhstan

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32048890
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.
Results Reference
derived

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

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