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CompletedNCT01929473Updated Jul 12, 2016Results posted

Seroepidemiological Study of Pertussis and Other Infectious Diseases

An observational study in Pertussis Infection, sponsored by Gifu Prefecture Medical Association. Completed at 1 site in Japan. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-12.

Sponsored by Gifu Prefecture Medical Association · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,830
Ages
12 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Pertussis Infection

Keywords

  • Pertussis infection
  • Risk factors
03

In context

Infections

6,688 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 3,830 is above the median of 240 across 2,136 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

This is the only study on the registry with Gifu Prefecture Medical Association as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Students of junior high school, high school or college

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

Exclusion Criteria:

  • None
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,830 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. IgG

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

    Time frame: 0 day, 365 day (2 points)

Secondary outcomes

  1. Incidence of Pertussis

    Questionnaire

    Time frame: 0 day

  2. Antibodies of Varicella, Mumps and Rubella

    Questionnaire

    Time frame: 0 day

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

    Questionnaire

    Time frame: 365 day

07

Results

Posted Jul 12, 2016

Participant flow

Participant flow — Overall Study
MilestoneBlood Drawings (0 Day, 365 Day) and Questionnaires
Started3830
365 day3589
Completed3243
Not completed587

Outcome measures

PrimaryIgG

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

Time frame:
0 day, 365 day (2 points)
Reported as:
Mean · EU/mL(log transformed)
IgG
EU/mL(log transformed)Blood Drawings (0 Day, 365 Day) and Questionnaires
0 day1.254 ± 0.008
365 day1.258 ± 0.007
SecondaryIncidence of Pertussis

Questionnaire

Time frame:
0 day

Results for this outcome have not been posted.

SecondaryAntibodies of Varicella, Mumps and Rubella

Questionnaire

Time frame:
0 day

Results for this outcome have not been posted.

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

Questionnaire

Time frame:
365 day

Results for this outcome have not been posted.

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Blood Drawings (0 Day, 365 Day) and Questionnaires—0/3,243 (0%)0/3,243 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Blood Drawings (0 Day, 365 Day) and Questionnaires
Mean13.9 ± 1.56
Sex: Female, Male
Sex: Female, Male(Participants)Blood Drawings (0 Day, 365 Day) and Questionnaires
Female1605
Male1638
Region of Enrollment
Region of Enrollment(participants)Blood Drawings (0 Day, 365 Day) and Questionnaires
Japan3243
08

Study locations

1 site
  • Gifu, Japan
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01929473
Lead sponsor
Gifu Prefecture Medical Association
Collaborators
Sanofi Pasteur S.A.
Responsible party
Sponsor
First posted
Aug 28, 2013
Start date
Sep 2013
Primary completion
Nov 2014
Completion
Nov 2014
Results posted
Jul 12, 2016
Last update
Jul 12, 2016

Study contacts

Naoki Kawai
study chair · Gifu Prefecture Medial Association

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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