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Seroepidemiological Study of Pertussis and Other Infectious Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Blood Drawings (0 Day, 365 Day) and Questionnaires No text entered.

Participant Flow:   Overall Study
    Blood Drawings (0 Day, 365 Day) and Questionnaires
STARTED   3830 [1] 
365 Day   3589 
COMPLETED   3243 
NOT COMPLETED   587 
[1] 0 day



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Blood Drawings (0 Day, 365 Day) and Questionnaires No text entered.

Baseline Measures
   Blood Drawings (0 Day, 365 Day) and Questionnaires 
Overall Participants Analyzed 
[Units: Participants]
 3243 
Age 
[Units: Years]
Mean (Standard Deviation)
 13.9  (1.56) 
Gender 
[Units: Participants]
 
Female   1605 
Male   1638 
Region of Enrollment 
[Units: Participants]
 
Japan   3243 


  Outcome Measures

1.  Primary:   IgG   [ Time Frame: 0 day, 365 day (2 points) ]

2.  Secondary:   Incidence of Pertussis   [ Time Frame: 0 day ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Antibodies of Varicella, Mumps and Rubella   [ Time Frame: 0 day ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   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 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Tsutomu Takeda
Organization: IROM CS Co., Ltd.
phone: +81-92-738-0500
e-mail: tsutomu-takeda@irom-cs.co.jp



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