Sanofi starts Phase 3 clinical trial of rotavirus vaccine

Written By Unknown on Selasa, 14 Oktober 2014 | 23.25

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.

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.

Sanofi India stock price

On October 14, 2014, Sanofi India closed at Rs 3259.40, down Rs 31.2, or 0.95 percent. The 52-week high of the share was Rs 3693.80 and the 52-week low was Rs 2312.05.


The company's trailing 12-month (TTM) EPS was at Rs 121.06 per share as per the quarter ended June 2014. The stock's price-to-earnings (P/E) ratio was 26.92. The latest book value of the company is Rs 584.74 per share. At current value, the price-to-book value of the company is 5.57.


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