Pertussis Infection
Conditions
Keywords
Pertussis infection, Risk factors
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.
Interventions
None listed
Sponsors
Sanofi Pasteur S.A.
Gifu Prefecture Medical Association
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IgG | 0 day, 365 day (2 points) | Seroincidence of pertussis estimated by the elevation of Ig-G-PT in paired sera(0day, 365day). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Pertussis | 0 day | Questionnaire |
| Antibodies of Varicella, Mumps and Rubella | 0 day | Questionnaire |
| Infection Risk Factors Including Family Numbers, Living Space, With or Without a Cough Patient in the Surroundings, Medical History and Hospitalization | 365 day | Questionnaire |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Blood Drawings (0 Day, 365 Day) and Questionnaires | 3,243 |
| Total | 3,243 |
Baseline characteristics
| Characteristic | Blood Drawings (0 Day, 365 Day) and Questionnaires |
|---|---|
| Age, Continuous | 13.9 years STANDARD_DEVIATION 1.56 |
| Region of Enrollment Japan | 3243 participants |
| Sex: Female, Male Female | 1605 Participants |
| Sex: Female, Male Male | 1638 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 3,243 |
| serious Total, serious adverse events | 0 / 3,243 |
Outcome results
Primary
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Blood Drawings (0 Day, 365 Day) and Questionnaires | IgG | 0 day | 1.254 EU/mL(log transformed) | Standard Deviation 0.008 |
| Blood Drawings (0 Day, 365 Day) and Questionnaires | IgG | 365 day | 1.258 EU/mL(log transformed) | Standard Deviation 0.007 |
Secondary
Antibodies of Varicella, Mumps and Rubella
Questionnaire
Time frame: 0 day
Secondary
Incidence of Pertussis
Questionnaire
Time frame: 0 day
Secondary
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