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Seroepidemiological Study of Pertussis and Other Infectious Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01929473
Recruitment Status : Completed
First Posted : August 28, 2013
Results First Posted : July 12, 2016
Last Update Posted : July 12, 2016
Sponsor:
Collaborator:
Sanofi Pasteur S.A.
Information provided by (Responsible Party):
Gifu Prefecture Medical Association

Brief Summary:

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.


Condition or disease
Pertussis Infection

Study Type : Observational
Actual Enrollment : 3830 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Seroepidemiological Study of Pertussis and Other Infectious Diseases
Study Start Date : September 2013
Primary Completion Date : November 2014
Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Whooping Cough
U.S. FDA Resources




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Incidence of Pertussis [ Time Frame: 0 day ]
    Questionnaire

  2. Antibodies of Varicella, Mumps and Rubella [ Time Frame: 0 day ]
    Questionnaire

  3. 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


Biospecimen Retention:   Samples Without DNA
Serum


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Students of junior high school, high school or college
Criteria

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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01929473


Locations
Japan
Gifu, Japan
Sponsors and Collaborators
Gifu Prefecture Medical Association
Sanofi Pasteur S.A.
Investigators
Study Chair: Naoki Kawai Gifu Prefecture Medial Association

Responsible Party: Gifu Prefecture Medical Association
ClinicalTrials.gov Identifier: NCT01929473     History of Changes
Other Study ID Numbers: G-P001
First Posted: August 28, 2013    Key Record Dates
Results First Posted: July 12, 2016
Last Update Posted: July 12, 2016
Last Verified: June 2016

Keywords provided by Gifu Prefecture Medical Association:
Pertussis infection
Risk factors

Additional relevant MeSH terms:
Whooping Cough
Communicable Diseases
Infection
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Respiratory Tract Diseases