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

NCT03572491 | Completed Phase 3

• 1 other identifier: VSI-III-01/2017
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Influenza

Outcome Measures

Primary Outcomes (1)

• 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).

  180 days

Secondary Outcomes (7)

• Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs)

  21 days

• Percentage of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)

  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

  Greater than 2 hours after administration of any dose of vaccine or placebo through 7 days

• Serious adverse events (SAEs), including abnormal laboratory findings

  up to 24 weeks

• Geometric Mean Fold Increase in HI Antibody Titer

  Change from Baseline HI Antibody Titer at 21, 90 and 180 days

Study Arms (1)

Allantoic split inactivated seasonal influenza vaccine

EXPERIMENTAL

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)).

Biological: influenza vaccine

Interventions

influenza vaccine BIOLOGICAL

Allantoic split inactivated seasonal influenza vaccine

Allantoic split inactivated seasonal influenza vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Research Institute for Biological Safety Problems: lead
• Asfendiyarov Kazakh National Medical University: collaborator
• Research Institute of Influenza, Russia: collaborator

Study Sites (1)

Research Institute for Biological Safety Problems

Gvardeysky, Jambul, 080409, Kazakhstan

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: June 28, 2018
• Study Start: September 18, 2017
• Primary Completion: May 21, 2018
• Study Completion: May 21, 2018
• Last Updated: June 28, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

KA (1)