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

• ClinicalTrials.gov Identifier: NCT03572491
• Recruitment Status: Completed
• First Posted: June 28, 2018
• Last Update Posted: June 28, 2018
• Sponsor: Research Institute for Biological Safety Problems
• Collaborators: Asfendiyarov Kazakh National Medical University; Research Institute of Influenza, Russia
• Information provided by (Responsible Party): Research Institute for Biological Safety Problems

Tracking Information

• First Submitted Date: June 5, 2018
• First Posted Date: June 28, 2018
• Last Update Posted Date: June 28, 2018
• Actual Study Start Date: September 18, 2017
• Actual Primary Completion Date: May 21, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 18, 2018)

Preventive efficacy - Incidence of influenza among vaccinated and unvaccinated volunteers [ Time Frame: 180 days ]

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).

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: June 18, 2018)

• Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs) [ Time Frame: 21 days ]
  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) [ Time Frame: Greater than 2 hours after administration of any dose of vaccine or placebo through 7 days following any dose ]
• 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 ]
• Serious adverse events (SAEs), including abnormal laboratory findings [ Time Frame: up to 24 weeks ]
• Geometric Mean Fold Increase in HI Antibody Titer [ Time Frame: Change from Baseline HI Antibody Titer at 21, 90 and 180 days ]
  1A group
• Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer [ Time Frame: Change from Baseline HI Antibody Titer at 21, 90 and 180 days ]
  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 [ Time Frame: Change from Baseline HI Antibody Titer at 21, 90 and 180 days ]
  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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.

• Study Type: Interventional
• Study Phase: Phase 3

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Prevention

• Condition: Human Influenza

Intervention

Biological: influenza vaccine

Allantoic split inactivated seasonal influenza vaccine

Study Arms

Experimental: Allantoic split inactivated seasonal influenza vaccine

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: Biological: influenza vaccine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 18, 2018): 2000
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: May 21, 2018
• Actual Primary Completion Date: May 21, 2018 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Kazakhstan

Administrative Information

• NCT Number: NCT03572491
• Other Study ID Numbers: VSI-III-01/2017
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Research Institute for Biological Safety Problems
• Original Responsible Party: Same as current
• Current Study Sponsor: Research Institute for Biological Safety Problems
• Original Study Sponsor: Same as current

Collaborators

• Asfendiyarov Kazakh National Medical University
• Research Institute of Influenza, Russia

• Investigators: Not Provided
• PRS Account: Research Institute for Biological Safety Problems
• Verification Date: June 2018