A Phase 3, an Open Clinical Trials to Evaluate Effectiveness, Safety and Immunogenicity of a Allantoic Split Inactivated Seasonal Influenza Vaccine in Healthy Adults

Research Institute for Biological Safety Problems1 site in 1 country2,000 target enrollmentSeptember 18, 2017

ConditionsHuman Influenza

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Human Influenza
Sponsor: Research Institute for Biological Safety Problems
Enrollment: 2000
Locations: 1
Primary Endpoint: Preventive efficacy - Incidence of influenza among vaccinated and unvaccinated volunteers
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 18, 2017

End Date

May 21, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Research Institute for Biological Safety Problems

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

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).

Secondary Outcomes

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)
Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer(Change from Baseline HI Antibody Titer at 21, 90 and 180 days)
Seroprotection Rate of HI Antibody Titer(Change from Baseline HI Antibody Titer at 21, 90 and 180 days)