Petrovax Group initiates clinical studies of A/H1N1 flu virus vaccines on children

On October 9^th, 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 latest-generation subunit inactivated adjuvanted A/H1N1 vaccine fully complying with all WHO requirements. It contains Polyoxidonium, an immunoadjuvant.

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 preservative-free in disposable single-dose syringes at Petrovax Group’s facility in Podolsk district of Moscow region to the international GMP standards. MA No. LSR-008177/09 of 16.10.2009 was issued by the Federal Service for Surveillance in Healthcare and Social Development (Roszdravnadzor) for Petrovax LLC, a Petrovax Group company.

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. LSR-008178/09 of 16.10.2009 was issued by Roszdravnadzor for Petrovax LLC, a Petrovax Group company.

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 I. P. Pavlov State Medical University (both St. Petersburg); they included two-time vaccination of volunteer groups consisting of 60 and 90 subjects. All procedures were performed under close medical supervision.

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.v. Nekrasov: "On November 9, we initiated vaccination of children at St. Petersburg Research Institute of Children’s Infections. Two days of observations demonstrated that MonoGrippol Neo and MonoGrippol were well-tolerated; there were no drug reactions, either overall or topical. On November 11, Petrovax Group initiated vaccination of children at Ekaterinburg Children’s City Hospital No. 8."

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 seven-day intervals between initiating trials with participation of different age groups of children.