Petrovax Group, a Russian innovative pharmaceutical and vaccine developer and manufacturer, declares the start of production of MonoGrippol Neo, a vaccine targeting highly pathogenic influenza virus A/H1N1.
MonoGrippol Neo is a latest-generation inactivated subunit adjuvant vaccine that fully conforms to the WHO requirements. The vaccine was developed based on an innovative cell technology for antigen development, which provides for prescribing it to patients with hen egg white allergy. MonoGrippol Neo will be manufactured preservative-free in disposable single-dose syringes to international GMP standards at Petrovax Group site in Podolsk district of Moscow region. Through the end of 2009, 11 m vaccine doses will be manufactured.
MonoGrippol Neo demonstrated its high safety and efficacy in clinical trials in adults, and was registered by the Russian Federal Service for Surveillance in Healthcare and Social Development (Roszdravnadzor). The clinical trials were performed on the sites of the Research Institute of Children’s Infections and I.P. Pavlov State Medical University (both St. Petersburg); they included a double immunization of the volunteer groups consisting of 60 and 90 subjects. All procedures were performed strictly under the care of physicians.
Besides MonoGrippol Neo, the clinical trials embraced MonoGrippol, a monovalent analogue of widely known seasonal influenza vaccine Grippol. MonoGrippol was developed using egg-based technology of antigen development.
It is also worth noting that Petrovax Group was issued a permit for conducting MonoGrippol Neo and MonoGrippol clinical trials in children that, in accordance with the protocol approved, were launched on November 5th, 2009. The clinical trials are run at two clinical sites, namely St. Petersburg Research Institute of Children’s Infections and Children’s Municipal Hospital No. 8 (Ekaterinburg).
The children included in the study age 3 to 17. They were divided into three age groups: 12-18 years, 7-11 years, and 3-6 years. The oldest age group was the first to participate in the study. After completion of the first stage of the study as well as vaccine safety and reactogenicity observation stage, the study will be continued in younger children. There will be seven-day intervals between the study launches in different children groups.
MonoGrippol developed by Petrovax Group will be manufactured by FSUE Research Institute of Vaccines & Sera and Bacteriologicals Enterprise.