DiarrheaNCT01133808
Effectiveness of Rotavirus Immunization in Nicaragua
An observational study of Diarrhea, run by Sylvia Becker-Dreps.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Diarrhea
- How many people
- 667 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Jan 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Children under age 5 in Leon, Nicaragua
Who may be able to join
- Age under 5 years, inclusion in health and demographic surveillance system (CIDS) in Leon, Nicaragua
Who cannot join
- Parents do not consent to child's participation
About this study
Official title: Effectiveness of Rotavirus Immunization at the Community Level in Nicaragua
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.
- Conditions
- Diarrhea
- Keywords
- diarrhea, childhood, rotavirus, vaccine, Nicaragua
- Medical subject headings
- Diarrhea
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 667 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sylvia Becker-Dreps
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Thrasher Research Fund, Fogarty International Center of the National Institute of Health
- Responsible party
- Sponsor-investigator, Sylvia Becker-Dreps, University of North Carolina, Chapel Hill
- Investigators
- Sylvia Becker-Dreps, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01133808
- Sponsor's protocol ID
- 09-0371
- Other IDs
- K01TW008401-01
- Status last verified
- Sep 2011
- First submitted
- 27 May 2010
- Last updated
- 9 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Rotavirus Immunization at the Community Level in Nicaragua
- ClinicalTrials.gov ID
- NCT01133808
- Acronym / sponsor ID
- 09-0371
- Conditions
- Diarrhea
- Keywords
- diarrhea, childhood, rotavirus, vaccine, Nicaragua
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 667 participants (actual)
- Lead sponsor
- Sylvia Becker-DrepsUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Thrasher Research Fund, Fogarty International Center of the National Institute of Health
- Study start
- Jan 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 31 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children under age 5 in Leon, Nicaragua
Key inclusion criteria (1 listed)
- Age under 5 years, inclusion in health and demographic surveillance system (CIDS) in Leon, Nicaragua
Key exclusion criteria (1 listed)
- Parents do not consent to child's participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sylvia Becker-Dreps, MD principal investigator
University of North Carolina, Chapel Hill
Questions about this trial
What is this clinical trial studying?
An observational study of Diarrhea, run by Sylvia Becker-Dreps.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2011.