NCT01175252 - 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)

Lanzieri TM et al
Impact of rotavirus vaccination on childhood diarrheal deaths in Brazil. Abstract presented at the 9th International Rotavirus Symposium (IRS). Johannesburg, South Africa, 2-3 August 2010.
Lanzieri TM et al
The impact of rotavirus vaccination on gastroenteritis hospitalizations among children <5 years in Brazil. Abstract presented at the 6th World Congress of World Society for Pediatric Infectious Diseases (WSPID). Buenos Aires, Argentina, 18-22 November 2009.
Lanzieri TM, Costa I, Shafi FA, Cunha MH, Ortega-Barria E, Linhares AC, Colindres RE
Trends in hospitalizations from all-cause gastroenteritis in children younger than 5 years of age in Brazil before and after human rotavirus vaccine introduction, 1998-2007. Pediatr Infect Dis J. 2010 Jul;29(7):673-5. doi: 10.1097/INF.0b013e3181da8f23.

Time Trend Analysis of Diarrhea-related Hospitalizations and Deaths in Children < 5 Years of Age in Brazil, 1990-2010

Clinical trial NCT01175252 - References