Status:
COMPLETED
Effectiveness of Rotarix™ Against Rotavirus Severe Gastroenteritis (RV SGE) in Infants in Panama
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Rotavirus
Eligibility:
All Genders
12+ years
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 bor...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 19 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 18 2011
Estimated Enrollment :
885 Patients enrolled
Trial Details
Trial ID
NCT00653198
Start Date
March 19 2008
End Date
March 18 2011
Last Update
September 5 2017
Active Locations (1)
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1
GSK Investigational Site
Panama City, Panama