OCT Successfully Completes Full-Cycle Varicella Vaccine Clinical Trial in Russia

Contract Research Organization OCT announces the successful completion of a full-cycle clinical trial evaluating the immunological efficacy, reactogenicity, and safety of a new vaccine for the prevention of varicella (chickenpox) in children and adults. The project was carried out for a domestic manufacturer of immunobiological products.

The study consisted of two sequential parts. The first part was a single-group, non-comparative, open-label study involving twenty adult volunteers aged 18 to 45 years. Its purpose was a preliminary assessment of the safety profile, reactogenicity, and immunogenicity of a two-dose vaccination regimen to support the decision to proceed to the main phase. The second, main part was a multicenter, randomized, double-blind, comparator-controlled, parallel-group study involving two hundred children and adolescents aged from nine months to seventeen years.

A key feature of the project was its complex phased design. Data from the first stage enabled the decision to initiate enrollment into the pediatric part. Subsequently, within the main part, sixty adolescents aged 13 to 17 years were vaccinated, followed by an unblinded interim safety data analysis. The results were reviewed by an independent Data Monitoring Committee, which included invited external experts, and the committee issued a positive recommendation to continue enrollment. This allowed the remaining one hundred and forty subjects aged from nine months to twelve years to be included.

A total of 220 volunteers participated in the study, which was conducted at eight centers across the Russian Federation. Vaccination was administered twice with an interval of at least six weeks, with safety and immunogenicity assessments performed 42 days after each administration. The total duration of participation for each subject was up to 105 days.

The OCT team provided a full range of operational services, including study design, site selection, monitoring, data management, and medical writing. The project is currently in its final stage, with the clinical study report nearing completion. The next key milestone is the closure of all investigational sites and the delivery of the complete study archive to the Sponsor. The results of this clinical trial will be submitted to the regulatory authorities for the purpose of registering the Varicella Vaccine for the prevention of chickenpox in the Russian Federation in children and adolescents aged 9 months to 17 years (inclusive).

For partnership inquiries and additional information, please contact us at info@oct-cro.com.