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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01363726
Other study ID # sor415005ctil
Secondary ID
Status Recruiting
Phase N/A
First received May 30, 2011
Last updated May 31, 2011
Start date October 2005

Study information

Verified date October 2005
Source Soroka University Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Observational

Clinical Trial Summary

The purpose of this study is to monitor diarrheal disease and observe changes after the introduction of the rota vaccine.


Description:

Monitoring of diarrheal disease and observe changes after the introduction of the rota vaccine Comparing the epidemiology in Jewish and Bedouin population before and after the introduction of the rota vaccine into the national immunization program


Recruitment information / eligibility

Status Recruiting
Enrollment 30000
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 5 Years
Eligibility Inclusion Criteria:

1. Children < 5 years with

2. Gastro enteritis

3. Visiting the ER

4. Residents of southern Israel

5. Signed informed concent -

Exclusion Criteria:

Not all of the above

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Israel Pediatric infectious disease unit Soroka U medical center Beer Sheva

Sponsors (1)

Lead Sponsor Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary epidemiology of rota virus disease in southern Israel before and after the rota virus vaccine introduction To assess the proportion of rotavirus gastroenteritis among children <5 years of age visiting the pediatric ER in southern Israel. To assess the hospitalization rate due to rotavirus. 7 years No
Secondary To compare rotavirus gastroenteritis among children <5 years of age from Jewish and Bedouin populations. To compare rotavirus gastroenteritis among children <5 years of age from Jewish and Bedouin populations. 7 years No
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