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

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)
Seroincidence of pertussis estimated by the elevation of Ig-G-PT in paired sera(0day, 365day).
0 day, 365 day (2 points)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Pertussis
Time Frame: 0 day
Questionnaire
0 day
Antibodies of Varicella, Mumps and Rubella
Time Frame: 0 day
Questionnaire
0 day
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
Questionnaire
365 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gifu Prefecture Medical Association

Collaborators

Sanofi Pasteur S.A.

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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