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| Name | Class |
|---|---|
| Asfendiyarov Kazakh National Medical University | OTHER |
| Research Institute of Influenza, Russia | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group #1 (Allantoic Split Inactivated Seasonal flu Vaccine) | Active Comparator | 100 volunteers aged 18 to 60 years, which introduced the vaccine allantoic split inactivated seasonal influenza |
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| Group #2 (Allantoic Split Inactivated Seasonal flu Vaccine) | Active Comparator | 100 volunteers over the age of 60 years, which introduced the vaccine allantoic split inactivated seasonal influenza |
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| Group #3 (Vaccine VAXIGRIP) | Experimental | 50 volunteers aged 18 to 60 years, which introduced vaccine VAXIGRIP |
|
| Group #4 (Vaccine VAXIGRIP) | Experimental | 50 volunteers over the age of 60 years, which introduced vaccine VAXIGRIP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allantoic Split Inactivated Seasonal flu Vaccine | Biological | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Fold Increase in HI Antibody Titer | 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. | Change from Baseline HI Antibody Titer at 21 days |
| Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer | 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. | Change from Baseline HI Antibody Titer at 21 days |
| 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 days after vaccination. Day 1 data is reported for reference. | Change from Baseline HI Antibody Titer at 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Berik M Khairullin, PhD | Research Institute for Biological Safety Problems | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kazakh National Medical University | Almaty | 050000 | Kazakhstan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32048890 | Derived | Sarsenbayeva G, Issagulov T, Kassenov M, Abitay R, Orynbayev M, Stukova M, Pisareva M, Davlyatshin T, Lespek K, Khairullin B. Safety and immunogenicity of trivalent inactivated influenza vaccine in adults 60 years of age and older: a phase II, a randomized, comparative trial in Kazakhstan. Hum Vaccin Immunother. 2020 Aug 2;16(8):1791-1797. doi: 10.1080/21645515.2019.1705691. Epub 2020 Feb 12. |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C478242 | vaxigrip |
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| VAXIGRIP | Biological | Vaxigrip - Seasonal Influenza, split virion, inactivated vaccine. Sanofi Pasteur Serial Number N3E681V |
|
| 21 Days |
| Percentage of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) | 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. | 21 Days |
| Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs | The percentage of participants with any abnormal standard safety laboratory values (Chemistry, Hematology and Urinalysis) collected throughout the study reported as AEs. | 21 Days |
| Serious adverse events (SAEs), including abnormal laboratory findings | 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. | 21 Days |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |