Gastroenteritis From Rotavirus Infection in Brazilian Children Less Than 5 Years of Age (Study V260-031).

This study has been terminated.
(Inadequate recruitment)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01195844
First received: September 3, 2010
Last updated: March 17, 2014
Last verified: March 2014
Results First Received: November 8, 2012  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Pediatric Gastroenteritis
Intervention: Biological: Rotavirus Vaccine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Children Hospitalized For Diarrhea Children up to 5 years of age hospitalized for diarrhea in the 4 Brazilian hospital research centers

Participant Flow:   Overall Study
    Children Hospitalized For Diarrhea  
STARTED     230  
COMPLETED     190  
NOT COMPLETED     40  
Fecal sample not collected                 40  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Children Who Provided a Fecal Sample Children up to 5 years of age hospitalized for diarrhea and providing a fecal sample in the 4 Brazilian hospital research centers. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period.

Baseline Measures
    Children Who Provided a Fecal Sample  
Number of Participants  
[units: participants]
  190  
Age, Customized  
[units: participants]
  190  
Gender  
[units: participants]
 
Female     84  
Male     106  
Rotavirus Vaccination Received  
[units: Participants]
 
Yes     175  
No     15  



  Outcome Measures
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1.  Primary:   The Number of Hospitalizations for Diarrhea in Children up to 5 Years of Age   [ Time Frame: 1 year ]

2.  Primary:   The Percentage of Hospitalizations for Diarrhea in Children up to 5 Years of Age   [ Time Frame: 1 year ]

3.  Primary:   The Geographic Distribution of Hospitalizations for Diarrhea That Are Caused by Rotavirus   [ Time Frame: 1 year ]

4.  Primary:   The Percentage of Hospitalizations for Diarrhea That Are Caused by Rotavirus   [ Time Frame: 1 year ]

5.  Primary:   The Number of Hospitalizations for Diarrhea That Are Caused by Rotavirus by Age Group   [ Time Frame: 1 year ]

6.  Primary:   The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month   [ Time Frame: 1 year ]

7.  Primary:   The Duration of Hospitalization for Participants Enrolled in the Study   [ Time Frame: From hospital admission to discharge ]

8.  Primary:   The Number of Deaths in Hospitalized Participants Enrolled in the Study   [ Time Frame: 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01195844     History of Changes
Other Study ID Numbers: V260-031
Study First Received: September 3, 2010
Results First Received: November 8, 2012
Last Updated: March 17, 2014
Health Authority: Brazil: Ethics Committee