NCT03016143

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

A Randomized, Blinded, Comparative Study of Phase II Allantoic Split Inactivated Seasonal Influenza Vaccine in Healthy Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Research Institute for Biological Safety Problems · Other Government
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

Summary

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).

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Allantoic Split Inactivated Seasonal flu Vaccine	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).
BIOLOGICAL	VAXIGRIP	Vaxigrip - Seasonal Influenza, split virion, inactivated vaccine. Sanofi Pasteur Serial Number N3E681V

Timeline

• Start date: 2016-10-01
• Primary completion: 2016-11-01
• Completion: 2016-12-01
• First posted: 2017-01-10
• Last updated: 2018-06-07

Locations

1 site across 1 country: Kazakhstan