Hyderabad, October 15, 2014 – Shantha Biotechnics, an arm of vaccine maker Sanofi Pasteur, has commenced phase-II 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.
Three doses safe
“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,’’ said Harish Iyer, Shantha CEO.
The phase I and II studies aim to produce a locally-licenced vaccine that is safe and able to protect children against rotavirus gastroenteritis.
“Overall, the results showed that all three doses of the vaccine evaluated in the study were safe, well-tolerated and displayed good immunogenicity (dose response) in healthy Indian infants,’’ the company said.
Rotavirus infections 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. Business LIne