A Randomized, Blinded, Comparative Study of Phase II Allantoic Split Inactivated Seasonal Influenza Vaccine in Healthy Adults
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Influenza
- Sponsor
- Research Institute for Biological Safety Problems
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Geometric Mean Fold Increase in HI Antibody Titer
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The study is a single centre, phase II, double-blind, randomized, comparative trial that explored the immunogenicity and safety of single dose a allantoic split inactivated seasonal influenza vaccine and VAXIGRIP vacccine in healthy adults the two age groups (in persons 18 to 60 years of age and older than 60 years).
Investigators
Eligibility 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.
Outcomes
Primary Outcomes
Geometric Mean Fold Increase in HI Antibody Titer
Time Frame: Change from Baseline HI Antibody Titer at 21 days
Geometric mean fold increase in HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination, as compared with Baseline.
Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer
Time Frame: Change from Baseline HI Antibody Titer at 21 days
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 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.
Seroprotection Rate of HI Antibody Titer
Time Frame: Change from Baseline HI Antibody Titer at 21 days
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 days after vaccination. Day 1 data is reported for reference.
Secondary Outcomes
- Percentage of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)(21 Days)
- Serious adverse events (SAEs), including abnormal laboratory findings(21 Days)
- Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs(21 Days)
- Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs)(21 Days)