Effectiveness of Rotavirus Immunization in Nicaragua | NCT01133808

Studies
Effectiveness of Rotavirus Immunization in Nicaragua

NCT01133808

Sponsor

Sylvia Becker-Dreps

Status

Completed

Last Update Posted

Sep 9, 2011Estimated

Enrollment

667Actual

Phase

Not provided

Conditions

Diarrhea

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
K01TW008401-01	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Sep 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Jan 2011Actual

Completion Date

Jan 2011Actual

First Submitted Date

May 27, 2010

First Submission Date that Met QC Criteria

May 28, 2010

First Posted Date

May 31, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 8, 2011

Last Update Posted Date

Sep 9, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sylvia Becker-Dreps, Assistant Professor, Department of Family Medicine, University of North Carolina, Chapel HillSponsor-Investigator

Lead Sponsor

Sylvia Becker-DrepsOTHER

Collaborators

Name	Class
Merck Sharp & Dohme LLC	INDUSTRY
Thrasher Research Fund	OTHER
Fogarty International Center of the National Institute of Health	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the investigators study is to compare the rates of childhood diarrhea at the community level before and after the rotavirus vaccination program in León, Nicaragua. From preliminary studies, the investigators anticipate about a 28% reduction in diarrhea following the vaccination program among children who received the vaccine, and a smaller reduction in diarrhea among children who did not receive the vaccine, due to the effects of "herd immunity". In addition, the investigators will collect stool samples from children who develop diarrhea in order determine the etiology of childhood diarrhea in the post-rotavirus immunization era.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

667Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age under 5 years, inclusion in health and demographic surveillance system (CIDS) in Leon, Nicaragua

Exclusion Criteria:

Parents do not consent to child's participation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

5 Years

Standard Ages

Child

Study Population

Children under age 5 in Leon, Nicaragua

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sylvia Becker-Dreps, MD	University of North Carolina, Chapel Hill	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003967	Diarrhea

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

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Browse Branches

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