Date: 2014-10-14
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Shantha Biotechnics (India) Sanofi Pasteur (France)
Product: tetravalent rotavirus vaccine candidate
Action
mechanism: 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.
Disease: rotavirus gastroenteritis
Therapeutic area: Infectious diseases
Country:
Trial details:
Latest
news: * On October 14, 2014, 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 4 weeks intervals. Close to 1,200 volunteers are being sought at 12 clinical trial sites in India. 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.
