Sanofi Pasteur, the vaccines division of Sanofi, announced the start of a Phase III clinical trial in India for its investigational rotavirus vaccine, developed and manufactured by its affiliate Shantha Biotechnics in Hyderabad, India. 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 four weeks intervals. Close to 1,200 volunteers are being sought at 12 clinical trial  sites in India. Shantha's investigational rotavirus vaccine includes antigens against serotypes G1, G2, G3, and G4.

A Phase I/II study 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. 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.

​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 6 to 32 weeks. Each dose is an all-in-one formulation containing an antacid. The vaccine is a live-attenuated bovine-human reassortant comprising four serotypes, G1, G2, G3 and G4, and is targeted to be  safe, confer non-

Shantha, which was acquired by Sanofi Pasteur Holding in 2009, is a biotechnology company founded by Dr. K I Varaprasad Reddy in 1993 in Hyderabad, India.

The World Health Organization recommends that vaccination with rotavirus vaccines should be included in all national immunization programs. Gavi, a public/private partnership focused on vaccines, has established an accelerated vaccine introduction initiative with the objective of driving the sustainable introduction of rotavirus vaccine in 30 Gavi-eligible countries by 2015. In addition, PATH, an international, non-profit organization to improve public health, is working to accelerate access to rotavirus vaccines and sustain their implementation and use in countries where needed.

Source: Sanofi