Sanofi Pasteur SA, the vaccines division of Sanofi, on Tuesday announced the start of human clinical trials in India for its rotavirus vaccine, developed and manufactured by its affiliate Shantha Biotechnics Ltd in Hyderabad.

Rotavirus infections cause severe diarrhoea in children.

“The trial is designed to show non-inferiority against a currently licensed vaccine with the use of three, ready-to-use liquid doses administered orally, starting from six-to-eight weeks of age, with the subsequent doses administered at 4 weeks intervals," Sanofi said in a statement.

Close to 1,200 volunteers are being sought at 12 clinical trial sites in India. The first two phases of the trials were carried out with the long-term aim to produce a locally licensed vaccine that is safe and able to protect children against rotavirus gastroenteritis.

Overall, the initial results showed that all three doses of the vaccine evaluated in the study were safe, well tolerated and displayed good response to the dose in healthy Indian infants, the company said.

“We aim to provide an affordable vaccine to meet the still significant medical need in emerging markets, like India, and through partnerships with organizations like GAVI, the Vaccine Alliance," said Olivier Charmeil, Sanofi Pasteur’s president and chief executive officer.

“Sanofi Pasteur wants to be in the position to target a major role in the growing rotavirus market in developing countries, with a key focus on the GAVI market, in public markets for non-GAVI countries, as well as private segments in emerging markets," said Charmeil.

The Global Alliance for Vaccines and Immunisation, also known as the GAVI Alliance, comprises governments of developing and donor countries, the World Health Organization, Unicef, the World Bank, vaccine makers, research and technical agencies, civil society organisations, the Bill and Melinda Gates Foundation and other private philanthropists. GAVI focuses on saving children’s lives and protecting people’s health by increasing access to immunization in poor countries.

Hyderabad-based vaccine maker Bharat Biotech International Ltd is also developing a vaccine against rotavirus, which is going through phase-III or human clinical trial. Bharat Biotech announced in 2013 that it will make its potential vaccine Rotavac available for one dollar a dose.

GlaxoSmithKline Plc (GSK) and Merck and Co. are the only two companies in the world that produce and market rotavirus vaccine. GSK made an offer to supply its rotavirus vaccine, Rotarix, to GAVI at $2.50 per dose, a small fraction of developed world prices. Merck followed suit by offering to reduce its price to $5 a dose.

Shantha’s investigational vaccine is designed to prevent severe rotavirus gastroenteritis in infants and children when administered as a three-dose series to infants between the ages of six and 32 weeks.

The World Health Organization estimates that in 2008, approximately 453,000 rotavirus gastroenteritis-associated child deaths occurred worldwide.

It is estimated that one of every 260 children born each year will die from diarrhoea caused by rotavirus infection by their fifth birthday. Studies indicate that rotavirus causes approximately 40% of childhood diarrhoeal hospitalizations worldwide and 39% Indian children less than five years of age are affected by the rotavirus.

These fatalities accounted for about 5% of all child deaths and a cause-specific mortality rate of 86 deaths per 100,000 population aged less than five years. About 90% of all rotavirus-associated fatalities occur in low-income countries in Africa and Asia and are related to poor healthcare.

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