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
Study complete
Study complete
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:
Enrollment:
885
Primary completion date:
2011-18-03
Observational study model:
Case-Control
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
Study complete
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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