The trio are accused of failing to safeguard the health of infants who were given an unregistered vaccine as part of the trial, according to a report in the Moscow Times.
Confirming that the charges had been laid, a GSK spokesperson told Outsourcing-Pharma.com that the company is "pretty confident that no wrongdoing will be found."
It is alleged that clinical trials, which were approved by the Russian regulatory authorities in 2005, were carried out by the Volgograd Railway Hospital on healthy children as well as those with pre-existing health problems, when a condition of the trial approval was that only healthy children could take part.
It is also alleged that a handful of children have experienced health complications and/or developed learning difficulties after receiving the vaccines.
In addition, Russian prosecutors claim that many parents were not properly informed that their children were taking part in a clinical trial and thought the vaccinations were routine.
Prosecutors opened the investigation in March in response to a complaint from the parents of a girl who was one year old when she was allegedly given the vaccine in November 2005, the Moscow Times reported.
The GSK spokesperson stressed that GSK itself was not directly linked to the charges or the allegations and that it was too early to speculate whether the charges brought against the three doctors would lead to actual legal proceedings.
The official statement released by GSK reads: "Audits undertaken by both GSK and Russian Federal regulatory bodies have concluded that this clinical study was conducted in line with the high ethical standards for such research.
The study was granted a permit by the Federal Service of Supervision in Sphere of Healthcare and Social Development; was approved by the Ethics Committee attached to the Federal Body of Medicines Quality Control; and has been carried out in full accordance with the requirements of Russian law."
The UK drug giant said that it holds all the necessary legal and regulatory approvals for the trial to take place and also has records of informed consent that were given by all the parents of children participating in the trial.
"GSK remains extremely concerned that unsubstantiated allegations about this clinical study continue to circulate and welcomes the decision made by the Federation Council to write to the Chief Federal Prosecutor to ask him to take on the case."
The tests in question were part of a global Phase IV clinical trial programme for three of GSK's paediatric vaccines - Varilrix for chickenpox, Priorix for measles, mumps and rubella (MMR) and Priorix Tetra, a combination of the two.
5,700 toddlers across Europe were involved in the programme, 1,000 of which came from Russia and roughly 100 from the Volgograd site.
According to GSK spokesperson, the allegations of an adverse event in a child participating in a clinical trial in the Volgograd Railway Hospital "arose through anonymous email campaign sent to the Russian media."
"The allegations arose through anonymous emails sent to the Russian media."
However, the spokesperson said they "would not like to speculate" as to why somebody would do this.
"As a sponsor to this trial, GSK is greatly concerned that despite repeated efforts by clinicians at the Railway Hospital, and GSK, no clinicians involved in the trial have been able to gain access to assess the child and provide the necessary help," said a GSK statement.
"Whilst an independent medical assessment cannot validate the alleged adverse event reported in Russia, the adverse event is alleged to have occurred 52 days after vaccination.
On this basis, Russian medical authorities have stated that any clinical relationship between the adverse event and the vaccine is highly unlikely."
Meanwhile, the incident raises the issue of how much trust big pharma firms - with big reputations at stake - are handing over to contract research organisations (CROs) and other third party companies when they enlist them to run trials on their behalf, particularly in emerging countries where the stringent regulations and standard practices of the west may not always be rigorously enforced.
Clinical trials account for two thirds of the development cost for new drugs and offshoring to lower-cost locations outside the US and Western Europe is becoming a common way for trial sponsors to keep costs down by providing access to a new range of patients, aiding recruitment.
Russia trailed only behind China in a recent poll of the most attractive low-cost global locations to run clinical trials outside the US.
In the case of this trial, the Railway hospital was contracted by GSK for a reported $50,000 (€38,000) to run clinical trials on its behalf, in the absence of any suitable CROs in the region.
The GSK spokesperson said, however, that "this is a unique incident and I do not think it is something typical of our relationships with contractors."
In addition, they confirmed that GSK did not terminate the contract that it had with the hospital early as a result of the incident.