Last updated: 11/03/2018 12:58:10
Trends Over Time (1990-2010) of Diarrhoea-related Hospitalizations and Deaths in Children < 5 Years of Age in Brazil
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Time trend analysis of diarrhea-related hospitalizations and deaths in children < 5 years of age in Brazil, 1990-2010
Trial description: This study aims at collecting data to obtain baseline incidence and monitor trends over time in hospitalizations and deaths from all cause gastroenteritis in children <5 years of age, before and after implementation of Rotarix™ universal mass vaccination in Brazil.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Occurrence of all cause gastroenteritis related hospital discharges and deaths
Timeframe: In post vaccine introduction period compared to pre-vaccination period (gastroenteritis related hospital discharges from 1998 to 2010, gastroenteritis related deaths from 1990 to 2009)
Secondary outcomes:
Occurrence of all cause gastroenteritis related hospital discharges and hospital deaths by year, region and age groups
Timeframe: From 1998 to 2010
Occurrence of all cause gastroenteritis related deaths by year, region and age groups
Timeframe: From 1990 to 2009
Interventions:
Other: Database analysis
Enrollment:
1
Observational study model:
Ecologic or Community
Primary completion date:
Not applicable
Time perspective:
Retrospective
Clinical publications:
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 et al. (2010) Trends in hospitalizations from all-cause gastroenteritis in children <5 years of age in Brazil before and after human rotavirus vaccine introduction, 1998-2007. Pediatr Infect Dis J. 29(7):673-675.
Lanzieri TM et al. (2010) Trends in hospitalizations from all-cause gastroenteritis in children <5 years of age in Brazil before and after human rotavirus vaccine introduction, 1998-2007. Pediatr Infect Dis J. 29(7):673-675.
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. 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.
Costa I et al. (2016) Sustained Decrease in Gastroenteritis-related Deaths and Hospitalizations in Children Less Than 5 Years of Age After the Introduction of Rotavirus Vaccination: A Time-Trend Analysis in Brazil (2001-2010). Pediatr Infect Dis J. 35(6):e180-190. doi: 10.1097/INF.0000000000001143.
Medical condition
Diarrhoea
Product
SB444563
Collaborators
Not applicable
Study date(s)
December 2008 to June 2012
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable N/A - 5 years
Accepts healthy volunteers
No
- Gastroenteritis associated hospital discharges and gastroenteritis related deaths occurring in children <5 years of age during the period analyzed and registered in the DATASUS databases will be collected for the study
- Not applicable
Inclusion and exclusion criteria
Inclusion criteria:
- Gastroenteritis associated hospital discharges and gastroenteritis related deaths occurring in children <5 years of age during the period analyzed and registered in the DATASUS databases will be collected for the study
Exclusion criteria:
- Not applicable
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2012-28-06
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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