Immunogenicity and Safety Study of Allantoic Split Inactivated Seasonal Influenza Vaccine (VSI)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03016143
• Date of registration: 04/01/2017
• Prospective Registration: No
• Primary sponsor: Research Institute for Biological Safety Problems
• Public title: Immunogenicity and Safety Study of Allantoic Split Inactivated Seasonal Influenza Vaccine (VSI)
• Scientific title: A Randomized, Blinded, Comparative Study of Phase II Allantoic Split Inactivated Seasonal Influenza Vaccine in Healthy Adults
• Date of first enrolment: October 2016
• Target sample size: 300
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03016143
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Kazakhstan

Contacts

• Name: Berik M Khairullin, PhD
• Affiliation: Research Institute for Biological Safety Problems

Key inclusion & exclusion criteria

Inclusion Criteria:

- volunteers (men and women) aged 18 years and older.

- Literate and willing to provide written informed consent.

- A signed informed consent.

Exclusion Criteria:

- Available in anamnaze volunteer at any allergic reactions.

- Allergic reactions to chicken proteins, or any preceding vaccination.

- Acute illness with a fever (37.0 C).

- Vaccination against influenza in the 2015/2016 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.

- Any clinically significant abnormal laboratory finding.

- 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.



Age minimum: 18 Years
Age maximum: 100 Years
Gender: All

Health Condition(s) or Problem(s) studied

Influenza

Intervention(s)

Biological: VAXIGRIP

Biological: Allantoic Split Inactivated Seasonal flu Vaccine

Primary Outcome(s)

Geometric Mean Fold Increase in HI Antibody Titer [Time Frame: Change from Baseline HI Antibody Titer at 21 days]

Seroprotection Rate of HI Antibody Titer [Time Frame: Change from Baseline HI Antibody Titer at 21 days]

Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer [Time Frame: Change from Baseline HI Antibody Titer at 21 days]

Secondary Outcome(s)

Percentage of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) [Time Frame: 21 Days]

Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs) [Time Frame: 21 Days]

Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs [Time Frame: 21 Days]

Serious adverse events (SAEs), including abnormal laboratory findings [Time Frame: 21 Days]

Secondary ID(s)

VSI-II-01/2016

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Research Institute of Influenza, Russia

Asfendiyarov Kazakh National Medical University