A Randomized, Blinded, Placebo-controlled Study of Phase I Allantoic Split Inactivated Seasonal Influenza Vaccine in Healthy Adults
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Influenza, Human
- Sponsor
- Research Institute for Biological Safety Problems
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The study is a single centre, phase I, double-blind, randomized, placebo-controlled trial that explored the safety and immunogenicity of single dose a allantoic split inactivated seasonal influenza vaccine in healthy adults.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy volunteers of both sexes aged 18-60 years.
- •Persons seronegative against A/H1N1 influenza virus, A/H3N2 and type B (with antibody titers ≤1: 10, according to hemagglutination-inhibition (HI) assay to determine).
- •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 2012/2013 season.
- •Seropositive volunteers against A/H1N1 influenza virus, A/H3N2 and type B (with antibody titers greater than 1:10 according HI).
- •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.
Outcomes
Primary Outcomes
Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs
Time Frame: Greater than 2 hours after administration of any dose of vaccine or placebo through 7 days
The percentage of participants with any abnormal standard safety laboratory values (Chemistry, Hematology and Urinalysis) collected throughout the study reported as AEs.
Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs)
Time Frame: Two hours
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.
Percentage of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)
Time Frame: Greater than 2 hours after administration of any dose of vaccine or placebo through 7 days following any dose
Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product. TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
Serious adverse events (SAEs), including abnormal laboratory findings
Time Frame: Three weeks of receipt
Serious adverse events (SAEs) are medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Secondary Outcomes
- Geometric Mean Fold Increase in HI Antibody Titer(Change from Baseline HI Antibody Titer at 21 days)
- Seroprotection Rate of HI Antibody Titer(Change from Baseline HI Antibody Titer at 21 days)
- Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer(Change from Baseline HI Antibody Titer at 21 days)