Clinical trial NCT03572491: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Human Influenza
Lead sponsor: Research Institute for Biological Safety Problems
Sponsor class: OTHER_GOV
Collaborators: name: Asfendiyarov Kazakh National Medical University
name: Research Institute of Influenza, Russia
First posted: 2018-06-28
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Preventive efficacy - Incidence of influenza among vaccinated and unvaccinated volunteers
timeFrame: 180 days
Secondary outcomes:
measure: Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs)
timeFrame: 21 days
measure: Percentage of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)
timeFrame: Greater than 2 hours after administration of any dose of vaccine or placebo through 7 days following any dose
measure: Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs
timeFrame: Greater than 2 hours after administration of any dose of vaccine or placebo through 7 days
measure: Serious adverse events (SAEs), including abnormal laboratory findings
timeFrame: up to 24 weeks
measure: Geometric Mean Fold Increase in HI Antibody Titer
timeFrame: Change from Baseline HI Antibody Titer at 21, 90 and 180 days
measure: Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer
timeFrame: Change from Baseline HI Antibody Titer at 21, 90 and 180 days
measure: Seroprotection Rate of HI Antibody Titer
timeFrame: Change from Baseline HI Antibody Titer at 21, 90 and 180 days
Other outcomes:
Locations:
city: Gvardeysky
country: Kazakhstan
facility: Research Institute for Biological Safety Problems
state: Jambul
Study officials:
References: