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3167 children enrolled in biggest rotavirus vaccine trials in South Africa : Synexus

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Friday, November 27, 2009, 18:52 This news item was posted in Biotech category and has 0 Comments so far.

3167 children will participate in a phase 3 trial to be conducted in South Africa to test a vaccine against rotavirus.

Rotavirus kills over half a million children each year, the vast majority in the developing world, and whilst vaccines have already been licensed for use in many Western countries, they are not yet available in parts of Africa where they are needed most.

Rotavirus vaccine trial in South Africa aims to evaluate the efficacy of the vaccine in the developing world and to assist with WHO pre-qualification of the rotavirus vaccine for use in Africa.

UK-based Synexus recruited the highest number of patients to the South African study investigating a paediatric vaccine against rotavirus.

Synexus has recruited over two thousand children aged between 5 and 10 weeks over the course of 3 months, making Synexus the largest single source of subjects for this Phase III trial involving over 3167 children across South Africa, the company said in a media release.

“Ensuring we recruited subjects to this trial promptly and managed this trial as efficiently as possible was vital. There is no denying the importance of implementing a vaccination programme against rotavirus as soon as possible in countries across Africa, where large numbers of very young children are dying needlessly. We were keen to work closely with the sponsors and other bodies involved, to drive this programme forward,” stated Dr Sanet Aspinall, managing director of Synexus in South Africa. Dr Sanet Aspinall¬† was the national coordinator of a consortium of 11 sites involving 3 organisations.

Rotavirus is the single most important cause of diarrhoea, responsible for 20 to 25% of all deaths due to diarrhoea and 6% of all deaths of children less than 5 years old.

Effective medical care results in only 20 to 40 children dying each year due to Rotavirus in the US, whilst in Africa the figures are between ten and fifteen thousand in children under 5.

In Africa and Asia alone, a Rotavirus with sixty per cent efficacy has the potential to save more than 1.5 million lives between 2010 and 2025.

Synexus, headquartered in Manchester, has a global network of Dedicated Research Centres (DRCs) in the UK, Poland, Hungary, Bulgaria, South Africa and India, Synexus provides first class clinical trials data to its clients from pharma, biotechs and CROs.

Synexus has, in the last 5 years, conducted hundreds of clinical trials across a broad range of therapeutic areas in Phases II to IV – in South Africa Synexus has a Phase I unit.

Currently Synexus has more than 14,000 patients in trials.

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