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Effectiveness of Rotarix™ Against Rotavirus Severe Gastroenteritis (RV SGE) in Infants in Panama
This study has been completed.
Study NCT00653198   Information provided by GlaxoSmithKline
First Received: March 19, 2008   Last Updated: May 21, 2009   History of Changes

March 19, 2008
May 21, 2009
March 2008
March 2009   (final data collection date for 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. [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT00653198 on ClinicalTrials.gov Archive Site
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. [ Designated as safety issue: No ]
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.
 
Effectiveness of Rotarix™ Against Rotavirus Severe Gastroenteritis (RV SGE) in Infants in Panama
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

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.

 
 
Observational
Observational Model:  Case Control
Time Perspective:  Prospective
Rotavirus Severe Gastroenteritis
Other: No intervention
Not applicable
Other Name: No intervention
  • B
    Controls
    Intervention: Other: No intervention
  • A
    Cases
    Intervention: Other: No intervention
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
263
March 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
12 Weeks and older
No
Contact information is only displayed when the study is recruiting subjects
Panama
 
NCT00653198
Study Director, GSK
104676
GlaxoSmithKline
 
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
May 2009

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