NCT01929473

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,830

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 28, 2013

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

July 12, 2016

Completed
Last Updated

July 12, 2016

Status Verified

June 1, 2016

Enrollment Period

1.2 years

First QC Date

August 15, 2013

Results QC Date

June 2, 2016

Last Update Submit

June 2, 2016

Conditions

Pertussis Infection

Keywords

Pertussis infectionRisk factors

Outcome Measures

Primary Outcomes (1)

  • IgG

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

    0 day, 365 day (2 points)

Secondary Outcomes (3)

  • Incidence of Pertussis

    0 day

  • Antibodies of Varicella, Mumps and Rubella

    0 day

  • Infection Risk Factors Including Family Numbers, Living Space, With or Without a Cough Patient in the Surroundings, Medical History and Hospitalization

    365 day

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Students of junior high school, high school or college

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Gifu, Japan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

Results Point of Contact

Title
Tsutomu Takeda
Organization
IROM CS Co., Ltd.
tsutomu-takeda@irom-cs.co.jp
+81-92-738-0500

Study Officials

  • Naoki Kawai

    Gifu Prefecture Medial Association

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2013

First Posted

August 28, 2013

Study Start

September 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

July 12, 2016

Results First Posted

July 12, 2016

Record last verified: 2016-06

Locations

JP(1)