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

Human Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03572491
• Other study ID #: VSI-III-01/2017
• Status: Completed
• Phase: Phase 3
• Start date: September 18, 2017
• Est. completion date: May 21, 2018

Study information

• Verified date: June 2018
• Source: Research Institute for Biological Safety Problems
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: May 21, 2018
• Est. primary completion date: May 21, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Human Influenza
• Influenza, Human

Intervention

Biological:
• influenza vaccine
Allantoic split inactivated seasonal influenza vaccine

Locations

Country	Name	City	State
Kazakhstan	Research Institute for Biological Safety Problems	Gvardeysky	Jambul

Sponsors (3)

Lead Sponsor	Collaborator
Research Institute for Biological Safety Problems	Asfendiyarov Kazakh National Medical University, Kazakhstan, Research Institute of Influenza, Russia

Country where clinical trial is conducted

Kazakhstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	21 days
Secondary	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
Secondary	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
Secondary	Serious adverse events (SAEs), including abnormal laboratory findings		up to 24 weeks
Secondary	Geometric Mean Fold Increase in HI Antibody Titer	1A group	Change from Baseline HI Antibody Titer at 21, 90 and 180 days
Secondary	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.	Change from Baseline HI Antibody Titer at 21, 90 and 180 days
Secondary	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.	Change from Baseline HI Antibody Titer at 21, 90 and 180 days