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Seroepidemiological Study of Pertussis and Other Infectious Diseases

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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

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Pertussis Infection
Enrollment 3830

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Blood Drawings (0 Day, 365 Day) and Questionnaires
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 3830 [1]
365 Day 3589
Completed 3243
Not Completed 587
[1]
0 day
Arm/Group Title Blood Drawings (0 Day, 365 Day) and Questionnaires
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 3243
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3243 participants
13.9  (1.56)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3243 participants
Female
1605
  49.5%
Male
1638
  50.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 3243 participants
3243
1.Primary Outcome
Title IgG
Hide Description Seroincidence of pertussis estimated by the elevation of Ig-G-PT in paired sera(0day, 365day).
Time Frame 0 day, 365 day (2 points)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Blood Drawings (0 Day, 365 Day) and Questionnaires
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 3243
Mean (Standard Deviation)
Unit of Measure: EU/mL(log transformed)
0 day 1.254  (0.008)
365 day 1.258  (0.007)
2.Secondary Outcome
Title Incidence of Pertussis
Hide Description Questionnaire
Time Frame 0 day
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Antibodies of Varicella, Mumps and Rubella
Hide Description Questionnaire
Time Frame 0 day
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Infection Risk Factors Including Family Numbers, Living Space, With or Without a Cough Patient in the Surroundings, Medical History and Hospitalization
Hide Description Questionnaire
Time Frame 365 day
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Blood Drawings (0 Day, 365 Day) and Questionnaires
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Blood Drawings (0 Day, 365 Day) and Questionnaires
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Blood Drawings (0 Day, 365 Day) and Questionnaires
Affected / at Risk (%)
Total   0/3243 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Blood Drawings (0 Day, 365 Day) and Questionnaires
Affected / at Risk (%)
Total   0/3243 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Name/Title: Tsutomu Takeda
Organization: IROM CS Co., Ltd.
Phone: +81-92-738-0500
Responsible Party: Gifu Prefecture Medical Association
ClinicalTrials.gov Identifier: NCT01929473     History of Changes
Other Study ID Numbers: G-P001
First Submitted: August 15, 2013
First Posted: August 28, 2013
Results First Submitted: June 2, 2016
Results First Posted: July 12, 2016
Last Update Posted: July 12, 2016