Phase III trial of investigational rotavirus vaccine by Shantha Biotechnics
Tuesday, October 14, 2014
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.
Sanofi Pasteur''s acquisition Shantha Biotechnics has started a stage III clinical trial in India for its investigational rotavirus vaccine, created and made in Hyderabad. The trial is intended to brief issues concerning non-inferior quality against authorized vaccine with the utilization of three, ready to-use liquid doses directed orally, beginning from six-to-eight weeks of age, with the dosages controlled at 4 weeks interims.
A stage I/II study was done with the long set goal expected to deliver a generally authorized immunization that is protected and ready to secure children against rotavirus gastroenteritis. In general, the results demonstrated that each of the three doses of the vaccine assessed in the study were safe to use, overall endured and showed great immunogenicity (dose-response) in healthy infants.
