A Phase 3 clinical trial for a 16-valent vaccine to prevent pneumococcal infections in children has started in Russia. The vaccine was developed by the St. Petersburg Research Institute of Vaccines and Serums, part of the Federal Medical-Biological Agency (FMBA). This information is according to data from the State Register of Medicines.
The trial aims to evaluate the immunogenicity, safety, and tolerability of the pneumococcal conjugate vaccine PCV-16. It will be compared against Pfizer’s Prevnar 13 vaccine in nearly 900 healthy children aged 2 to 17 years. The candidate vaccine is a suspension for intramuscular injection in a 0.5 ml dose.
The clinical trial will be conducted by the St. Petersburg-based company Exelena, which won the tender in January. According to public procurement data, the company offered to conduct the study for 224.4 million rubles, while the maximum contract price was 230.4 million rubles. The research will take place across 12 medical institutions in eight cities, including four sites in St. Petersburg.
Meanwhile, it was previously reported that Russian authorities have postponed the timelines for including several vaccinations in the national immunization schedule.