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

Phase 2 Completed 300 enrolled Research Institute for Biological Safety Problems Asfendiyarov Kazakh National Medical University · collab Research Institute of Influenza, Russia · collab

RandomizedParallel-groupQuadruple-blindPrevention

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).

Timeline

Start: 2016-10
Primary completion: 2016-11
Completion: 2016-12

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Allantoic Split Inactivated Seasonal flu Vaccine	Vaccine	0.5 ml	—
Subject	Influenza Virus Vaccine	Vaccine	0.5 ml	—

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

Summary

Timeline

Publications

Drugs

Indications