ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Effectiveness of Rotarix™ Against Rotavirus Severe Gastroenteritis (RV SGE) in Infants in Panama

This study is currently recruiting participants.
Study NCT00653198.   Last updated on October 9, 2008.   Information provided by GlaxoSmithKline

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
Brief Title  Effectiveness of Rotarix™ Against Rotavirus Severe Gastroenteritis (RV SGE) in Infants in Panama
Official Title  Hospital-Based, Case-Control Study to Assess the Vaccine Effectiveness of Rotarix™ Against Rotavirus Severe Gastroenteritis (RV SGE) Among Hospitalised Children Born After 1 March 2006 and at Least 12 Weeks of Age, in Panama
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
Study Phase
Study Type  Observational
Study Design  Case Control, Prospective
Primary Outcome Measure  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 Measure  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.
Condition  Rotavirus Severe Gastroenteritis
Intervention  Other: No intervention
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  1260
Start Date  March 2008
Completion Date
Eligibility Criteria 

Inclusion Criteria for enrolled subjects and cases :

  • A male or female child born after 1 March 2006 (which corresponds to the date of introduction of Rotarix™ in the EPI) and at least 12 weeks of age.
  • Subject admitted to the study hospital for SGE (refer to the glossary) during the study period.
  • Onset of SGE ≤ 14 days prior to admission.
  • Laboratory confirmed (i.e. by ELISA at the hospital laboratory) RV positive stool sample at hospital admission or during the first 48 hours of hospitalisation. Note: This criterion is applicable only for cases.
  • Written informed consent obtained from the parent or guardian of the subject.

Inclusion criteria for controls:

  • Admitted for non-GE causes at the same hospital as the case. Note: This criterion is applicable to hospital controls only.
  • Living in the same neighbourhood as the case for at least three consecutive months. Note: This criterion is applicable to neighbourhood controls only.
  • At least 12 weeks of age and being born within ± 2 weeks from the date of birth of the case. If the list of children born within ± 2 weeks is exhausted, then the range would be extended to ± 4 weeks.
  • Written informed consent obtained from the parent or guardian of the child.

Exclusion Criteria for enrolled subjects and cases:

  • Subject has previously participated as case or control in this study.
  • Hospitalisation is unrelated to GE.
  • Onset of SGE > 48 hours after admission to the hospital (nosocomial infections).

Exclusion criteria for controls:

  • For hospital controls: Child who has symptoms of GE during current hospitalisation or on the day of interview of his/her parent or guardian.

OR

  • For neighbourhood controls: Child who has symptoms of GE on the day of interview of his/her parent or guardian.
  • Exclude children with the following vaccine preventable diseases: measles, mumps, rubella, diphtheria, pertussis, tetanus, tuberculosis, invasive Haemophilus Influenzae Type B (Hib) infections (meningitis, bacteraemia, septic arthritis, cellulitis, and epiglottitis) and hepatitis B.
  • Child has participated in the past as a case or control in this study.
  • Child living in the same house as the case. Note: This criterion is applicable to neighbourhood controls only
Gender Both
Ages 12 Weeks and older
Accepts Healthy Volunteers No
Contacts ††
Contact: US GSK Clinical Trials Call Center     877-379-3718        
Location Countries  Panama
Administrative Information Fields
NCT ID  NCT00653198
Organization ID 104676
Secondary IDs ††
Study Sponsor  GlaxoSmithKline
Collaborators ††
Investigators 
Study Director:     GSK Clinical Trials     GlaxoSmithKline    
Information Provided By GlaxoSmithKline
Verification Date October 2008
First Received Date  March 19, 2008
Last Updated Date October 9, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




Links to all studies - primarily for crawlers