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Preventive Effectiveness, Safety and Immunogenicity of a Allantoic Split Inactivated Seasonal Influenza Vaccine

Primary Purpose

Human Influenza

Status
Completed
Phase
Phase 3
Locations
Kazakhstan
Study Type
Interventional
Intervention
influenza vaccine
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 Human Influenza

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy volunteers of both sexes aged from 18 years.
  • Literate and willing to provide written informed consent.
  • A signed informed consent.
  • Able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria:

  • Allergic reactions to chicken proteins, or any preceding vaccination.
  • Acute illness with a fever (37.0 C).
  • Vaccination against influenza in the 2017/2018 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.
  • 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

  • Research Institute for Biological Safety Problems

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Allantoic split inactivated seasonal influenza vaccine

Arm Description

A allantoic split inactivated seasonal influenza vaccine has been prepared on eggs and is made from inactivated parts of the following influenza virus strains: NYMC X-275 (A/PR/8/34 (M, PB2, PA, NS, NP genes) и A/Michigan/45/2015 (PB1, HA, NA genes)), NYMC X-263В (A/PR/8/34 (PB1, PB2, PA, NS, NP, М genes) и A/Hong Kong/4801/2014 (HA, NA genes)), NYMC BX-35 (B/Lee/40 (NP gene), B/Panama/45/90 (PB2, М genes) и B/Brisbane/60/2008 (HA, NA PB1, PA, NS genes)).

Outcomes

Primary Outcome Measures

Preventive efficacy - Incidence of influenza among vaccinated and unvaccinated volunteers
An assessment of the incidence of influenza among vaccinated and unvaccinated volunteers will be conducted within 180 days of observation (PCR diagnostics for the detection of influenza viruses).

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)
Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs
Serious adverse events (SAEs), including abnormal laboratory findings
Geometric Mean Fold Increase in HI Antibody Titer
1A group
Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer
1A group - 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, 90, 180 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, 90, 180 days after vaccination. Day 1 data is reported for reference.

Full Information

First Posted
June 5, 2018
Last Updated
June 18, 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
NCT03572491
Brief Title
Preventive Effectiveness, Safety and Immunogenicity of a Allantoic Split Inactivated Seasonal Influenza Vaccine
Official Title
A Phase 3, an Open Clinical Trials to Evaluate Effectiveness, Safety and Immunogenicity of a Allantoic Split Inactivated Seasonal Influenza Vaccine in Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
September 18, 2017 (Actual)
Primary Completion Date
May 21, 2018 (Actual)
Study Completion Date
May 21, 2018 (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

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study is Multicenter, phase 3, Open-Label trial that explored the preventive effectiveness, safety and immunogenicity of single dose a allantoic split inactivated seasonal influenza vaccine in healthy adults.
Detailed Description
The study will include 2000 volunteers, 1,000 of whom will be vaccinated intramuscularly with a single dose of allantoic split inactivated seasonal influenza vaccine. All participants will be observed for 6 months to evaluate the effectiveness of the vaccine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Influenza

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
The main group - group 1 = 1000 volunteers will be vaccinated with the vaccine "Allan-toxin split inactivated against seasonal influenza vaccine". In the main group, a subgroup will be singled out - a group of 1a = 200 volunteers who will be examined for safety, immunogenicity and immunity. The observation group is a group of 2 = 1000 people who, when confirming the diagnosis of influenza, will compare the incidence with the main group.
Masking
None (Open Label)
Allocation
N/A
Enrollment
2000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Allantoic split inactivated seasonal influenza vaccine
Arm Type
Experimental
Arm Description
A allantoic split inactivated seasonal influenza vaccine has been prepared on eggs and is made from inactivated parts of the following influenza virus strains: NYMC X-275 (A/PR/8/34 (M, PB2, PA, NS, NP genes) и A/Michigan/45/2015 (PB1, HA, NA genes)), NYMC X-263В (A/PR/8/34 (PB1, PB2, PA, NS, NP, М genes) и A/Hong Kong/4801/2014 (HA, NA genes)), NYMC BX-35 (B/Lee/40 (NP gene), B/Panama/45/90 (PB2, М genes) и B/Brisbane/60/2008 (HA, NA PB1, PA, NS genes)).
Intervention Type
Biological
Intervention Name(s)
influenza vaccine
Intervention Description
Allantoic split inactivated seasonal influenza vaccine
Primary Outcome Measure Information:
Title
Preventive efficacy - Incidence of influenza among vaccinated and unvaccinated volunteers
Description
An assessment of the incidence of influenza among vaccinated and unvaccinated volunteers will be conducted within 180 days of observation (PCR diagnostics for the detection of influenza viruses).
Time Frame
180 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)
Time Frame
Greater than 2 hours after administration of any dose of vaccine or placebo through 7 days following any dose
Title
Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs
Time Frame
Greater than 2 hours after administration of any dose of vaccine or placebo through 7 days
Title
Serious adverse events (SAEs), including abnormal laboratory findings
Time Frame
up to 24 weeks
Title
Geometric Mean Fold Increase in HI Antibody Titer
Description
1A group
Time Frame
Change from Baseline HI Antibody Titer at 21, 90 and 180 days
Title
Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer
Description
1A group - 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, 90, 180 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, 90 and 180 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, 90, 180 days after vaccination. Day 1 data is reported for reference.
Time Frame
Change from Baseline HI Antibody Titer at 21, 90 and 180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy volunteers of both sexes aged from 18 years. Literate and willing to provide written informed consent. A signed informed consent. Able to attend all scheduled visits and to comply with all trial procedures. Exclusion Criteria: Allergic reactions to chicken proteins, or any preceding vaccination. Acute illness with a fever (37.0 C). Vaccination against influenza in the 2017/2018 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. 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.
Facility Information:
Facility Name
Research Institute for Biological Safety Problems
City
Gvardeysky
State/Province
Jambul
ZIP/Postal Code
080409
Country
Kazakhstan

12. IPD Sharing Statement

Plan to Share IPD
No

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Preventive Effectiveness, Safety and Immunogenicity of a Allantoic Split Inactivated Seasonal Influenza Vaccine

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