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Shantha Biotechnics, an arm of vaccine maker Sanofi Pasteur, has commenced phase III clinical trial of its investigational rotavirus vaccine.
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.
``India has the largest disease burden for Rotavirus gastroenteritis in the world. The vaccine has the potential to offer benefits for the children in India,’’ Harish Iyer, Shantha CEO said.
Rotavirus infections, caused mostly by Group A viruses, are prevalent in human populations worldwide. Although the virus can and does infect older individuals, illness caused by rotavirus can be quite severe in infants and young children.
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