Maternal antibodies against pertussis in neonates .
- Conditions
- Pertussis disease is reported in very young children who have not yet been (fully) vaccinated and did not receive sufficient maternal antibodies. Augmenting maternal antibody titers by administering a prepregnancy booster in women is investigated as a way to protect young children.
- Registration Number
- EUCTR2010-023976-16-BE
- Lead Sponsor
- niversity of Antwerp
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
•Informed consent signed by the woman for her participation (vaccination and blood sample).
•Informed consent signed by both parents for the inclusion of the children.
•Pregnancy test negative in women at time of vaccination with Boostrix®.
•Available cord samples from a previous study in which older siblings were participating.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• pertussis vaccination of the woman <10 years before study start
• preterm delivery
• severe diseases in mother or child
• impaired immunology (diabetes mellitus, hiv, tumour…) in mother of child
• use of immunoglobulins during pregnancy and use of blood products during last three months of pregnancy
• use of immunoglobulins in children during the study period
• previous booster vaccination with tetanus-diphtheria vaccine in less than two years before inclusion.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method