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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00653198
First received: March 19, 2008
Last updated: March 17, 2011
Last verified: March 2011

March 19, 2008
March 17, 2011
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.
Not Provided
Not Provided
 
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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Stool samples

Probability Sample

Cases will include those children born after 1 March 2006, at least 12 weeks of age and hospitalised for RV SGE in the study hospital, during the designated study period. For each case, three hospital controls and three neighbourhood controls will be included in the study, after matching by date of birth. Hospital controls will be children hospitalised for non-GE causes in the study hospital during the same time period as the case. Neighbourhood controls will be children without any symptoms of GE or SGE, and residing in the same area as the case at least for three consecutive months.

Rotavirus Severe Gastroenteritis
Other: No intervention
Not applicable
Other Name: No intervention
  • A
    Cases
    Intervention: Other: No intervention
  • B
    Controls
    Intervention: Other: No intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
885
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
104676
Not Provided
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP