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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Infections, Rotavirus

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>Cases | Other: No intervention<br> <br> |
| B<br>Controls | Other: No intervention<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rotavirus severe gastroenteritis (RV SGE)