Seroepidemiological Study of Pertussis and Other Infectious Diseases

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Gifu Prefecture Medical Association
Sponsor:
Collaborator:
Sanofi Pasteur S.A.
Information provided by (Responsible Party):
Gifu Prefecture Medical Association
ClinicalTrials.gov Identifier:
NCT01929473
First received: August 15, 2013
Last updated: September 30, 2013
Last verified: September 2013
  Purpose

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
Pertussis Infection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Seroepidemiological Study of Pertussis and Other Infectious Diseases

Resource links provided by NLM:


Further study details as provided by Gifu Prefecture Medical Association:

Primary Outcome Measures:
  • IgG [ Time Frame: 0 day, 365 day (2 points) ] [ Designated as safety issue: No ]
    Seroincidence of pertussis estimated by the elevation of Ig-G-PT in paired sera(0day, 365day).


Secondary Outcome Measures:
  • Incidence of pertussis [ Time Frame: 0 day ] [ Designated as safety issue: No ]
    Questionnaire

  • Antibodies of varicella, mumps and rubella [ Time Frame: 0 day ] [ Designated as safety issue: No ]
    Questionnaire

  • 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 ] [ Designated as safety issue: No ]
    Questionnaire


Biospecimen Retention:   Samples Without DNA

Serum


Estimated Enrollment: 4500
Study Start Date: September 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01929473

Contacts
Contact: Tsutomu Takeda +81-92-738-0500

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

No publications provided

Responsible Party: Gifu Prefecture Medical Association
ClinicalTrials.gov Identifier: NCT01929473     History of Changes
Other Study ID Numbers: G-P001
Study First Received: August 15, 2013
Last Updated: September 30, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

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

ClinicalTrials.gov processed this record on September 30, 2014