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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 Multicenter, phase 3, Open-Label trial that explored the preventive effectiveness, safety and immunogenicity of single dose a allantoic split inactivated seasonal influenza vaccine in healthy adults.
The study will include 2000 volunteers, 1,000 of whom will be vaccinated intramuscularly with a single dose of allantoic split inactivated seasonal influenza vaccine.
All participants will be observed for 6 months to evaluate the effectiveness of the vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allantoic split inactivated seasonal influenza vaccine | Experimental | A allantoic split inactivated seasonal influenza vaccine has been prepared on eggs and is made from inactivated parts of the following influenza virus strains: NYMC X-275 (A/PR/8/34 (M, PB2, PA, NS, NP genes) и A/Michigan/45/2015 (PB1, HA, NA genes)), NYMC X-263В (A/PR/8/34 (PB1, PB2, PA, NS, NP, М genes) и A/Hong Kong/4801/2014 (HA, NA genes)), NYMC BX-35 (B/Lee/40 (NP gene), B/Panama/45/90 (PB2, М genes) и B/Brisbane/60/2008 (HA, NA PB1, PA, NS genes)). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| influenza vaccine | Biological | Allantoic split inactivated seasonal influenza vaccine |
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| Measure | Description | Time Frame |
|---|---|---|
| Preventive efficacy - Incidence of influenza among vaccinated and unvaccinated volunteers | An assessment of the incidence of influenza among vaccinated and unvaccinated volunteers will be conducted within 180 days of observation (PCR diagnostics for the detection of influenza viruses). | 180 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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Institute for Biological Safety Problems | Gvardeysky | Zhambyl | 080409 | Kazakhstan |
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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 |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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The main group - group 1 = 1000 volunteers will be vaccinated with the vaccine "Allan-toxin split inactivated against seasonal influenza vaccine".
In the main group, a subgroup will be singled out - a group of 1a = 200 volunteers who will be examined for safety, immunogenicity and immunity.
The observation group is a group of 2 = 1000 people who, when confirming the diagnosis of influenza, will compare the incidence with the main group.
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| 21 days |
| Percentage of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) | Greater than 2 hours after administration of any dose of vaccine or placebo through 7 days following any dose |
| Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs | Greater than 2 hours after administration of any dose of vaccine or placebo through 7 days |
| Serious adverse events (SAEs), including abnormal laboratory findings | up to 24 weeks |
| Geometric Mean Fold Increase in HI Antibody Titer | 1A group | Change from Baseline HI Antibody Titer at 21, 90 and 180 days |
| Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer | 1A group - 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, 90, 180 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, 90 and 180 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, 90, 180 days after vaccination. Day 1 data is reported for reference. | Change from Baseline HI Antibody Titer at 21, 90 and 180 days |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |