NCT00938327 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Kumar k et al
Safety and reactogenicity of RIX4414 live attenuated human rotavirus vaccine: An Indian post-marketing surveillance study. Abstract presented at the 48th National Conference of Indian Academy of Pediatrics (Pedicon). Jaipur, India, 19-23 January 2011.
Ruberu D et al
Post-marketing surveillance of a live-attenuated human rotavirus vaccine (Rotarix™) in India and Sri Lanka. Abstract presented at the 9th International Congress of Tropical Pediatrics (ICTP). Bangkok, Thailand, 18-20 October 2011.

Post Marketing Surveillance to Monitor the Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus Vaccine, Rotarix™ When Administered According to the Prescribing Information to Indian Infants

Details for clinical trial NCT00938327

Clinical trial NCT00938327 - References