Petrovax Group initiates clinical studies of A/H1N1 flu virus vaccines on children
On October 9th, Petrovax Group, a Russian developer and manufacturer of innovative pharmaceuticals and vaccines, initiated immunization of children with MonoGrippol Neo and MonoGrippol vaccines within the framework of clinical studies. MonoGrippol Neo is a
The vaccine was developed by Petrovax Group based on an innovative cell antigen production technology, which provides for its assigning in subjects with egg white allergy.
MonoGrippol Neo is produced
MonoGrippol is a monovalent analogue of widely known Grippol flu vaccine. It was developed by Petrovax Group based on an egg antigen production technology. The vaccine will be manufactured by St. Petersburg Research Institute of Vaccines and Sera under a license from Petrovax Group. MA No.
In October 2009, MonoGrippol Neo and MonoGrippol passed clinical studies on adults, and demonstrated satisfactory tolerability, safety, and absence of reactogenicity. Based on the study findings, Roszdravnadzor issued MAs for the vaccines. The clinical studies were conducted at the Research Institute of Children’s Infections and
On November 5, 2009, MonoGrippol Neo and MonoGrippol clinical studies on children were initiated at the Research Institute of Children’s Infections (St. Petersburg) and Children’s City Hospital No. 8 (Ekaterinburg). Volunteers have been enrolled. On November 9 and 11, the vaccines were injected in children following a written informed consent from their parents. The clinical studies are fully compliant with the protocol approved.
Petrovax Group Director General A.
The age of the children participating in the trial is 3 to 17 years. They were split into three age groups: 12–18, 7–11, and 3–6 years. The oldest age group was the first to take part in the study. After the completion of the first study stage as well as safety and reactogenicity observations, the trial will be continued on younger children. There will be