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Effectiveness of Rotarix™ Against Rotavirus Severe Gastroenteritis (RV SGE) in Infants in Panama

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00653198
Recruitment Status : Completed
First Posted : April 4, 2008
Last Update Posted : September 5, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date March 19, 2008
First Posted Date April 4, 2008
Last Update Posted Date September 5, 2017
Actual Study Start Date March 19, 2008
Actual Primary Completion Date March 18, 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 1, 2008)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 1, 2008)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Effectiveness of Rotarix™ Against Rotavirus Severe Gastroenteritis (RV SGE) in Infants in Panama
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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Stool samples
Sampling Method Probability Sample
Study Population Cases will include those children born after 1 March 2006, at least 12 weeks of age and hospitalised for RV SGE in the study hospital, during the designated study period. For each case, three hospital controls and three neighbourhood controls will be included in the study, after matching by date of birth. Hospital controls will be children hospitalised for non-GE causes in the study hospital during the same time period as the case. Neighbourhood controls will be children without any symptoms of GE or SGE, and residing in the same area as the case at least for three consecutive months.
Condition Infections, Rotavirus
Intervention Other: No intervention
Study Groups/Cohorts
  • A
    Cases
    Intervention: Other: No intervention
  • B
    Controls
    Intervention: Other: No intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 17, 2011)
885
Original Estimated Enrollment
 (submitted: April 1, 2008)
1260
Actual Study Completion Date March 18, 2011
Actual Primary Completion Date March 18, 2011   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 12 Weeks and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Panama
Removed Location Countries  
 
Administrative Information
NCT Number NCT00653198
Other Study ID Numbers 104676
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor GlaxoSmithKline
Collaborators Not Provided
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date September 2017