Seroepidemiological Study of Pertussis and Other Infectious Diseases

This study is currently recruiting participants.
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
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:
Communicable Diseases
Infection
Whooping Cough
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 16, 2014