Seroepidemiological Study of Pertussis and Other Infectious Diseases

• Sponsor: Gifu Prefecture Medical Association (Other)
• Overall Status: Completed
• CT.gov ID: NCT01929473
• Collaborator: Sanofi Pasteur S.A. (Other)
• Enrollment: 3,830
• Location: 1
• Duration (Months): 14
• Patients Per Site Per Month: 273.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pertussis Infection

Study Design

• Study Type: Observational
• Actual Enrollment: 3830 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Seroepidemiological Study of Pertussis and Other Infectious Diseases
• Study Start Date: Sep 1, 2013
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Nov 1, 2014

Outcome Measures

Primary Outcome Measures

1. IgG [0 day, 365 day (2 points)]

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

Secondary Outcome Measures

1. Incidence of Pertussis [0 day]

   Questionnaire

2. Antibodies of Varicella, Mumps and Rubella [0 day]

   Questionnaire

3. Infection Risk Factors Including Family Numbers, Living Space, With or Without a Cough Patient in the Surroundings, Medical History and Hospitalization [365 day]

   Questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1		Gifu		Japan

Sponsors and Collaborators

• Gifu Prefecture Medical Association
• Sanofi Pasteur S.A.

Investigators

• Study Chair: Naoki Kawai, Gifu Prefecture Medial Association

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gifu Prefecture Medical Association
• ClinicalTrials.gov Identifier: NCT01929473
• Other Study ID Numbers: G-P001
• First Posted: Aug 28, 2013
• Last Update Posted: Jul 12, 2016
• Last Verified: Jun 1, 2016

• Keywords provided by Gifu Prefecture Medical Association: Pertussis infection; Risk factors
• Additional relevant MeSH terms: Infections; Communicable Diseases; Whooping Cough

Study Results

Participant Flow

Arm/Group Title	Blood Drawings (0 Day, 365 Day) and Questionnaires
Arm/Group Description
Period Title: Overall Study
STARTED	3830
365 Day	3589
COMPLETED	3243
NOT COMPLETED	587

Baseline Characteristics

Arm/Group Title	Blood Drawings (0 Day, 365 Day) and Questionnaires
Arm/Group Description
Overall Participants	3243
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	13.9 (1.56)
Sex: Female, Male (Count of Participants)
Female	1605 49.5%
Male	1638 50.5%
Region of Enrollment (participants) [Number]
Japan	3243 100%

Outcome Measures

1. Primary Outcome

Title	IgG
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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Blood Drawings (0 Day, 365 Day) and Questionnaires
Arm/Group Description
Measure Participants	3243
0 day	1.254 (0.008)
365 day	1.258 (0.007)

2. Secondary Outcome

Title	Incidence of Pertussis
Description	Questionnaire
Time Frame	0 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Antibodies of Varicella, Mumps and Rubella
Description	Questionnaire
Time Frame	0 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

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
Description	Questionnaire
Time Frame	365 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Blood Drawings (0 Day, 365 Day) and Questionnaires
Arm/Group Description
All Cause Mortality
	Blood Drawings (0 Day, 365 Day) and Questionnaires
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Blood Drawings (0 Day, 365 Day) and Questionnaires
	Affected / at Risk (%)	# Events
Total	0/3243 (0%)
Other (Not Including Serious) Adverse Events
	Blood Drawings (0 Day, 365 Day) and Questionnaires
	Affected / at Risk (%)	# Events
Total	0/3243 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.