The vaccines unit of pharma giant Sanofi today announced the start of Phase III clinical trial in India of its investigational rotavirus vaccine developed and manufactured by its affiliate Shantha Biotechnics here.
Sanofi Pasteur announced the trial, which involves up to 1,200 volunteers.
The trial is designed to show non-inferiority against a currently licenced 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 four weeks intervals, according to Shantha Biotechnics.
"Close to 1,200 volunteers are being sought at 12 clinical trial sites in India," it said.
The study under Phases I/II was carried out with the long- term aim to produce a locally licensed vaccine that is safe and able to protect children against rotavirus gastroenteritis, the company said.
India has the largest disease burden for rotavirus gastroenteritis in the world, according to Shantha Chief Executive Harish Iyer.
