Shantha Biotechnics, which was acquired by Sanofi Pasteur in 2009, has commenced a phase III clinical trial in India for its investigational rotavirus vaccine, developed and manufactured in Hyderabad. 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.

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.

Olivier Charmeil, president and CEO of Sanofi Pasteur, said, “We aim to provide an affordable vaccine to meet the still significant medical need in emerging markets, like India, and through partnerships with organizations like Gavi, the Vaccine Alliance. Sanofi Pasteur wants to be the position to target a major role in the growing rotavirus market in developing countries, with a key focus on the Gavi market, in public markets for non-Gavi countries, as well as private segments in emerging markets.”

The World Health Organization (WHO) recommends that vaccination with rotavirus vaccines should be included in all national immunization programs. Gavi, 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 children need them most urgently.

Shantha's investigational vaccine is designed to prevent severe rotavirus gastroenteritis in infants and children when administered as a 3-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-inferior immunogenicity to already licensed vaccines and have the ability to prevent rotavirus gastroenteritis.

Four of Shantha's licensed vaccines namely, Shan5 paediatric vaccine, Shanchol Cholera vaccine, Shanvac-B hepatitis B vaccine, and ShanTT tetanus vaccine. are WHO-prequalified. Sanofi Pasteur and Shantha are also developing a new paediatric combination vaccine based on Shan5 that will incorporate Sanofi Pasteur's inactivated polio vaccine in order to secure polio eradication.