Infections, Rotavirus
Conditions
Keywords
Rotavirus severe gastroenteritis (RV SGE)
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.
Interventions
OTHERNo intervention
Sponsors
GlaxoSmithKline
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Weeks to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | 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
| Measure | 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. | — |
Countries
Panama
Outcome results
None listed