Gastroenteritis From Rotavirus Infection in Brazilian Children Less Than 5 Years of Age (Study V260-031 AM1).

This study has been terminated.

(Inadequate recruitment)

Sponsor:

Information provided by (Responsible Party):

Merck

ClinicalTrials.gov Identifier:

NCT01195844

First received: September 3, 2010

Last updated: January 2, 2013

Last verified: January 2013

History of Changes

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

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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

Hide Baseline Characteristics

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]
<5 years	190
Gender [units: participants]
Female	84
Male	106
Rotavirus Vaccination Received [units: Participants]
Yes	175
No	15

Outcome Measures

Show All Outcome Measures

1. Primary:

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

Show Outcome Measure 1

2. Primary:

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

Show Outcome Measure 2

3. Primary:

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

Show Outcome Measure 3

4. Primary:

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

Show Outcome Measure 4

5. Primary:

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

Show Outcome Measure 5

6. Primary:

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

Show Outcome Measure 6

7. Primary:

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

Show Outcome Measure 7

8. Primary:

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

Show Outcome Measure 8

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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:

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.

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.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Restriction Description:

The initial publication of this study will be multicenter, comprising data from all sites involved. After the multicenter publication, or 24 months after the end of the study, each site involved may publish its own results in an independent fashion.

The sponsor will also have the opportunity to review all the proposed abstracts, manuscripts or lectures related to this study 60 days before submission for publication/presentation.

Limitations and Caveats

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
No text entered.

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
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:	January 2, 2013
Health Authority:	Brazil: Ethics Committee

To Top