05.Dec.2017

OCT to start a clinical study in influenza vaccine

This is a multi-center, double-blind, randomized, parallel group clinical study to determine the immunologic efficacy, reactogenicity and safety of an investigational influenza vaccine.

The project includes 2 parts, divided by age groups of participants: children aged 6-11 years old and adolescents aged 12-17 years old. More than 200 subjects are expected to be randomized into each group. At the moment, OCT actively recruits patients into the first treatment arm.

Seasonal influenza has been a significant public health problem for many decades. Despite recent advances in pharmacotherapy and vaccines, annual population-based morbidity and mortality rates remain high throughout the world. According to the Research Institute of Influenza of the Ministry of Health of the Russian Federation, the epidemic outbreak threshold was exceeded by 21.5-56.9% in Russia in January 2017.

For this clinical trial, OCT provides project management services, clinical site monitoring, logistic support, quality assurance, preparation of interim and final reports. All data management and biostatistics services are provided by Data MATRIX.