Effectiveness of Rotarix™ Against Rotavirus Severe Gastroenteritis (RV SGE) in Infants in Panama

Completed

• Conditions: Infections, Rotavirus

• Registration Number: NCT00653198
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This study aims to estimate the effectiveness of Rotarix™ vaccine which is used nationwide as a part of the expanded program on immunization (EPI), in preventing RV SGE among hospitalised children born after 1 March 2006, which corresponds to the date of introduction of Rotarix™ in the national immunization program.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-19
• Study First Submitted: 2008-03-19
• Study First Submitted QC: 2008-04-01
• Study First Posted: 2008-04-04
• Primary Completion: 2011-03-18
• Study Completion: 2011-03-18
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-01
• Last Update Posted: 2017-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 885

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of RV GE among children born after 1 March 2006, at least 12 weeks of age and admitted to the study hospital for SGE.

Secondary Outcome Measures

Name	Time	Method
Occurrence of acute GE among children born after 1 March 2006, at least 12 weeks of age and admitted to the study hospital for SGE.

Trial Locations

Locations (1)

GSK Investigational Site; 🇵🇦 Panama, Panama