Effectiveness of Rotavirus Immunization in Nicaragua

Diarrhea Clinical Trial

Official title:

Effectiveness of Rotavirus Immunization at the Community Level in Nicaragua

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01133808
• Other study ID #: 09-0371
• Secondary ID: K01TW008401-01
• Status: Completed
• Phase: N/A
• First received: May 27, 2010
• Last updated: September 8, 2011
• Start date: January 2010
• Est. completion date: January 2011

Study information

• Verified date: September 2011
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of the investigators study is to compare the rates of childhood diarrhea at the community level before and after the rotavirus vaccination program in León, Nicaragua. From preliminary studies, the investigators anticipate about a 28% reduction in diarrhea following the vaccination program among children who received the vaccine, and a smaller reduction in diarrhea among children who did not receive the vaccine, due to the effects of "herd immunity". In addition, the investigators will collect stool samples from children who develop diarrhea in order determine the etiology of childhood diarrhea in the post-rotavirus immunization era.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 667
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 5 Years

Eligibility

Inclusion Criteria:

• Age under 5 years, inclusion in health and demographic surveillance system (CIDS) in Leon, Nicaragua

Exclusion Criteria:

• Parents do not consent to child's participation

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diarrhea

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Sylvia Becker-Dreps	John E. Fogarty International Center (FIC), Merck Sharp & Dohme Corp., Thrasher Research Fund