Immunisation of pregnant women with acellular Bordetella pertussis vaccine.
Withdrawn
- Conditions
- whooping cough1000401810028920
- Registration Number
- NL-OMON33816
- Lead Sponsor
- Groene Hart Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
Zie protocol pagina 16
Exclusion Criteria
Zie protocol pagina 16
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. Feasibility:<br /><br><br /><br>a. Part 1. Determination of pertussis specific antibody responses and<br /><br>persistence in mother and child after vaccination of the mother during<br /><br>pregnancy. Antibody titres of women vaccinated during pregnancy will be<br /><br>measured and compared with data from an ongoing study on titres in pregnant<br /><br>women not vaccinated during the study and with data on titres of pregnant women<br /><br>who have recently been infected with B. pertussis.<br /><br><br /><br>b. Part 2. Determination of transplacental transfer of different antibodies<br /><br>against B. pertussis and the decline of these antibodies in the infant post<br /><br>natal.<br /><br><br /><br>2. Safety:<br /><br><br /><br>a. Part 1. Rate of adverse events in pregnant women after immunization (using<br /><br>the WHO criteria).<br /><br><br /><br>b. Part 2. Rate of adverse events after immunization in infants of vaccinated<br /><br>mothers.</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. The number of infections with B. pertussis in infants and mothers after<br /><br>maternal vaccination until the first year after birth.<br /><br>2. The course of antibody-titers in infants of vaccinated mothers will be<br /><br>studied before and after routine childhood vaccination.<br /><br>3. Antibody-titers to diphtheria, tetanus and polio will be measured.</p><br>