Deaths of 14 children 'could be linked to GlaxoSmithKline trial drug'

The children took Synflorix as part of a clinical trial run by the British pharmaceutical company Glaxo-SmithKline.

It has been developed to fight pneumonia, ear infections and several other pneumococcal diseases.

Dr Marchesse said some illiterate parents were not told that the vaccine given to their children was experimental (posed by model)

Argentina's National Medicine, Food and Medical Technology Administration is examining whether there the vaccine is connected in any way with the youngsters' deaths.

A U. S. spokesman for GSK, Sarah Alspach, said the company did not believe the deaths were linked to the vaccine.

Synflorix is also being tested in Panama, Chile and some European countries, but it is not being tested in Britain.

Miss Alspach said that an independent board monitoring participants' safety recommended that the Latin American trials be temporarily suspended, but then gave its approval for tests to resume.

'We rely on their safety review,' she said. 'Safety is our primary concern, always, with the development of any new treatment.'

More than 19,000 babies have received at least one dose of Synflorix, which GSK plans to test on a total of 24,000 infants, she said.

The company is still enrolling participants. But officials at Argentina's food and drug administration said the agency had 'received complaints about irregularities in the recruitment of patients' for the drug trial and on July 31 asked that recruitment be suspended.

GSK stopped recruiting the following day, saying it had already gathered the necessary number of participants.

Ana Maria Marchesse, who heads one of two groups that notified the national food and drug administration, said that she had witnessed 'poor ethical management' of patient recruitment, with participants being unaware they were being given an experimental drug.

GSK said the number of deaths in the trial was lower than the natural infant death rate in Argentina, Panama and Chile for pneumonia.

Pneumonia is the world's top killer among infectious diseases, causing more than two million deaths a year in children under five, mostly in developing countries, Miss Alspach said.

She added that the company is testing the vaccine in more than 40 clinical studies around the world.

Data from other studies shows that the vaccine is about as safe and tolerable as competitor Wyeth's Prevnar, a vaccine widely used against pneumococcal disease, Miss Alpsach added.

However, the Argentinian province of Santiago del Estero is conducting a separate inquiry into the deaths of the seven children there, local health minister Franklin Moyano said.

'While legal authorities investigate, we're in an observation phase to see if everything happened as expected, or if there were deviations that caused damage, in this case the death of seven kids,' he said.