Effectiveness of Rotarix™ Against Rotavirus Severe Gastroenteritis (RV SGE) in Infants in Panama
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ClinicalTrials.gov Identifier: NCT00653198 |
Recruitment Status :
Completed
First Posted : April 4, 2008
Last Update Posted : September 5, 2017
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Condition or disease | Intervention/treatment |
---|---|
Infections, Rotavirus | Other: No intervention |
Study Type : | Observational |
Actual Enrollment : | 885 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
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 |
Actual Study Start Date : | March 19, 2008 |
Actual Primary Completion Date : | March 18, 2011 |
Actual Study Completion Date : | March 18, 2011 |

Group/Cohort | Intervention/treatment |
---|---|
A
Cases
|
Other: No intervention |
B
Controls
|
Other: No intervention |
- 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.
- 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.
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 12 Weeks and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00653198
Panama | |
GSK Investigational Site | |
Panama, Panama |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00653198 |
Other Study ID Numbers: |
104676 |
First Posted: | April 4, 2008 Key Record Dates |
Last Update Posted: | September 5, 2017 |
Last Verified: | September 2017 |
Rotavirus severe gastroenteritis (RV SGE) |
Rotavirus Infections Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
Reoviridae Infections RNA Virus Infections Virus Diseases |