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

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ClinicalTrials.gov Identifier: NCT03028116
Recruitment Status : Completed
First Posted : January 23, 2017
Last Update Posted : January 23, 2017
Sponsor:
Collaborators:
Asfendiyarov Kazakh National Medical University
Research Institute of Influenza, Russia
Information provided by (Responsible Party):
Research Institute for Biological Safety Problems

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.

Condition or disease Intervention/treatment Phase
Influenza, Human Biological: influenza vaccine Biological: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Blinded, Placebo-controlled Study of Phase I Allantoic Split Inactivated Seasonal Influenza Vaccine in Healthy Adults
Study Start Date : May 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Active Comparator: Allantoic split inactivated seasonal influenza vaccine
Allantoic split inactivated seasonal influenza vaccine
Biological: influenza vaccine

A allantoic split inactivated seasonal influenza vaccine has been prepared on eggs and is made from inactivated parts of the following influenza virus strains:

NIBRG-121xp (A/California/7/2009 (H1N1)v and А/PR/8/34 (H1N1)), NYMC X-217 (A/Victoria/361/2011(H3N2) and А/PR/8/34 (H1N1)), NYMC BX-49 (B/Texas/06/2011 (Yamagata lineage) - like High Yield Reassortant (1:1:6) With B/Lee/40 NP, B/Panama/45/90 NS genes).


Placebo Comparator: Placebo
Water for Injection
Biological: Placebo
water for injection




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  • 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.
  • Seropositive for HIV, hepatitis B surface antigen and/or hepatitis C antibodies.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03028116


Locations
Kazakhstan
Kazakh National Medical University
Almaty, Kazakhstan, 050000
Sponsors and Collaborators
Research Institute for Biological Safety Problems
Asfendiyarov Kazakh National Medical University
Research Institute of Influenza, Russia

Responsible Party: Research Institute for Biological Safety Problems
ClinicalTrials.gov Identifier: NCT03028116     History of Changes
Other Study ID Numbers: VSI-I-01/2016
First Posted: January 23, 2017    Key Record Dates
Last Update Posted: January 23, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Research Institute for Biological Safety Problems:
vaccine
1 phase
safety

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs