Preventive Effectiveness, Safety and Immunogenicity of a Allantoic Split Inactivated Seasonal Influenza Vaccine
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|ClinicalTrials.gov Identifier: NCT03572491|
Recruitment Status : Completed
First Posted : June 28, 2018
Last Update Posted : June 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Human Influenza||Biological: influenza vaccine||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2000 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||
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.
|Masking:||None (Open Label)|
|Official Title:||A Phase 3, an Open Clinical Trials to Evaluate Effectiveness, Safety and Immunogenicity of a Allantoic Split Inactivated Seasonal Influenza Vaccine in Healthy Adults|
|Actual Study Start Date :||September 18, 2017|
|Actual Primary Completion Date :||May 21, 2018|
|Actual Study Completion Date :||May 21, 2018|
Experimental: Allantoic split inactivated seasonal 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: 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)).
Biological: influenza vaccine
Allantoic split inactivated seasonal influenza vaccine
- Preventive efficacy - Incidence of influenza among vaccinated and unvaccinated volunteers [ Time Frame: 180 days ]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).
- Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs) [ Time Frame: 21 days ]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 ]
- 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 ]
- Serious adverse events (SAEs), including abnormal laboratory findings [ Time Frame: up to 24 weeks ]
- Geometric Mean Fold Increase in HI Antibody Titer [ Time Frame: Change from Baseline HI Antibody Titer at 21, 90 and 180 days ]1A group
- Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer [ Time Frame: Change from Baseline HI Antibody Titer at 21, 90 and 180 days ]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.
- Seroprotection Rate of HI Antibody Titer [ Time Frame: Change from Baseline HI Antibody Titer at 21, 90 and 180 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, 90, 180 days after vaccination. Day 1 data is reported for reference.
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): NCT03572491
|Research Institute for Biological Safety Problems|
|Gvardeysky, Jambul, Kazakhstan, 080409|