Last updated: 06/28/2019 09:40:29
Effectiveness of Rotarix™ against rotavirus severe gastroenteritis (RV SGE) in infants in Panama
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
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
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
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.
Timeframe: Not applicable
Secondary outcomes:
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.
Timeframe: Not applicable
Interventions:
Other: No intervention
Enrollment:
885
Observational study model:
Case-Control
Primary completion date:
2011-18-03
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Infections, Rotavirus
Product
SB208133, SB444563
Collaborators
Not applicable
Study date(s)
March 2008 to March 2011
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2011-18-03
Actual study completion date
2011-18-03
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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