- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01929473
Seroepidemiological Study of Pertussis and Other Infectious Diseases
June 2, 2016 updated by: Gifu Prefecture Medical Association
Serum samples will be corrected twice from the same youth subjects with one year interval.
Seroincidence of pertussis will be estimated by the elevation of Ig-G-PT in paired sera from an identical individual.
The relationship between the incidence and the demographic data or medical history of the subjects will be discussed.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
3830
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Gifu, Japan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Students of junior high school, high school or college
Description
Inclusion Criteria:
- Students of junior high school, high schools or college in Gifu prefecture
- Students who can have the second blood drawing one year later
- Students (and their parent when students are underage) whose written consent is obtainable.
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
IgG
Time Frame: 0 day, 365 day (2 points)
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Seroincidence of pertussis estimated by the elevation of Ig-G-PT in paired sera(0day, 365day).
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0 day, 365 day (2 points)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Pertussis
Time Frame: 0 day
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Questionnaire
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0 day
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Antibodies of Varicella, Mumps and Rubella
Time Frame: 0 day
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Questionnaire
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0 day
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Infection Risk Factors Including Family Numbers, Living Space, With or Without a Cough Patient in the Surroundings, Medical History and Hospitalization
Time Frame: 365 day
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Questionnaire
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365 day
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Naoki Kawai, Gifu Prefecture Medial Association
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
August 15, 2013
First Submitted That Met QC Criteria
August 21, 2013
First Posted (Estimate)
August 28, 2013
Study Record Updates
Last Update Posted (Estimate)
July 12, 2016
Last Update Submitted That Met QC Criteria
June 2, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- G-P001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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