NCT03572491

Preventive Effectiveness, Safety and Immunogenicity of a Allantoic Split Inactivated Seasonal Influenza Vaccine

A Phase 3, an Open Clinical Trials to Evaluate Effectiveness, Safety and Immunogenicity of a Allantoic Split Inactivated Seasonal Influenza Vaccine in Healthy Adults

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,000 (actual)
• Sponsor: Research Institute for Biological Safety Problems · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Human Influenza

Interventions

Type	Name	Description
BIOLOGICAL	influenza vaccine	Allantoic split inactivated seasonal influenza vaccine

Timeline

• Start date: 2017-09-18
• Primary completion: 2018-05-21
• Completion: 2018-05-21
• First posted: 2018-06-28
• Last updated: 2018-06-28

Locations

1 site across 1 country: Kazakhstan