Last updated: 06/18/2019 10:00:25
Study to Evaluate the Effectiveness of Rotarix™ Against Severe Gastroenteritis Among Hospitalized Children in Brazil
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Case-control Study to Evaluate the Vaccine Effectiveness of Rotarix™ Against Rotavirus Severe Gastroenteritis (RV SGE) Among Hospitalized Children Born After 6 March 2006 and at Least 12 Weeks of Age, in Belem, Brazil
Trial description: The purpose of this study is to estimate the effectiveness of 2 doses of Rotarix™ vaccination in preventing rotavirus severe gastroenteritis among children hospitalized in Belem area, Brazil.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Risk of Enzyme Linked Immunosorbent Assay (ELISA) confirmed rotavirus severe gastroenteritis in children fully vaccinated with Rotarix™, compared to risk of ELISA confirmed rotavirus severe gastroenteritis in unvaccinated children
Timeframe: Average time frame: 12-24 months
Secondary outcomes:
Risk of ELISA confirmed rotavirus severe gastroenteritis in children vaccinated with at least one dose of Rotarix™, compared to risk of ELISA confirmed rotavirus severe gastroenteritis in unvaccinated children
Timeframe: Average time frame: 12-24 months
Occurrence of severe gastroenteritis among children admitted to study clinics/hospitals for severe gastroenteritis
Timeframe: Average time frame: 12-24 months
Occurrence of rotavirus serotypes among children
Timeframe: Average time frame: 36 months
Interventions:
Procedure/surgery: Stool sampling
Enrollment:
1944
Observational study model:
Case-Control
Primary completion date:
2011-11-05
Time perspective:
Prospective
Clinical publications:
Justino MC et al. (2011) Effectiveness of the Monovalent G1P[8] Human Rotavirus Vaccine Against Hospitalization for Severe G2P[4] Rotavirus Gastroenteritis in Belém, Brazil. Pediatr Infect Dis J. 30(5):396-401.
Guerra SF et al. (2015) Rotavirus strain surveillance for three years following the introduction of rotavirus vaccine into Belém, Brazil. J Med Virol. 87(8):1303-1310.
Medical condition
Rotavirus gastroenteritis
Product
SB444563
Collaborators
Not applicable
Study date(s)
May 2008 to May 2011
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
- For cases:
- A male or female child born after 6 March 2006 and at least 12 weeks of age.
- For cases:
- Subject has previously participated as case or control in this study.
Inclusion and exclusion criteria
Inclusion criteria:
- For cases:
- A male or female child born after 6 March 2006 and at least 12 weeks of age.
- Subject admitted to the study clinics/hospitals for severe gastroenteritis during the study period.
- Onset of severe gastroenteritis ≤ 14 days prior to admission.
- Laboratory confirmed rotavirus positive stool sample at hospital admission or during the first 48 hours of hospitalization.
- Written informed consent obtained from the parent or guardian of the subject. For controls:
- Admitted for non-gastroenteritis causes at the same clinic/hospital as the case.
- Living in the same neighbourhood as the case for at least three consecutive months without any symptoms of gastroenteritis or severe gastroenteritis on the day of interview of his/ her parents/ guardians.
- Being born within +- 2 weeks from the date of birth of the case. If the number required is not available, then the range would be extended to +- 4 weeks, and ultimately up to +- 6 weeks for hospital controls. For neighbourhood controls, the range may be extended to +- 8 weeks.
- Written informed consent obtained from the parent or guardian of the child.
Exclusion criteria:
- For cases:
- Subject has previously participated as case or control in this study.
- Onset of severe gastroenteritis > 48 hours after admission to the hospital (nosocomial infections). For controls:
- For hospital controls: Child who has symptoms of gastroenteritis during current hospitalization or on the day of interview of his/her parent or guardian or for neighbourhood controls: Child who has symptoms of gastroenteritis or severe gastroenteritis 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
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
2011-11-05
Actual study completion date
2011-11-05
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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