Immunity to pertussis transmission and disease among household contacts of infected children.

Withdrawn

Conditions: whooping cough
10004018

Registration Number: NL-OMON48617

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 125

Inclusion Criteria

Child < 16 years old with a PCR-proven infection with Bordetella pertussis and
minimal 2 asymptomatic household contacts.

Exclusion Criteria

Households:
* With a pregnant contact (>34 weeks of gestation)
* With a contact younger than 6 months old or unvaccinated child.
* With a contact with significant disorders, including immunodeficiency,
cancer, oral steroid therapy or any other medical conditions
* With risk contacts for which antibiotic prophylaxis is recommended for the
whole household.
* In which it is not possible to organize visit T1 within 5 days.
Incapacitated Household contacts will be excluded.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of this study is to identify differences in immunological<br /><br>biomarkers at inclusion (T1) between confirmed infection (asymptomatic) and<br /><br>confirmed pertussis (symptomatic) in cases.<br /><br>We will measure immunological biomarkers in blood and in mucosal samples of<br /><br>household contacts at inclusion (T1) as well as changes in immunological<br /><br>biomarkers from T1 to T2 (=2 months after T1). As the primary objective, we<br /><br>will investigate differences in PT antibody responses at T1 and T2 between<br /><br>confirmed pertussis and confirmed infection (asymptomatic) cases (see<br /><br>highlighted rows in Table .<br /><br><br /><br>Primary endpoint. PT-IgG and PT-IgA geometric mean concentrations at T1 and T2</p><br>

Secondary Outcome Measures