Skip to content

Immunisation of pregnant women with acellular Bordetella pertussis vaccine.

Immunisation of pregnant women with acellular Bordetella pertussis vaccine. - Bordetella pertussis vaccination in pregnancy

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON33816
Enrollment
60
Registered
2009-07-30
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

whooping cough

Interventions

The study group will receive an DTaP-IPV booster vaccine, with reduced D and monovalent aP content vaccine during the third trimester of pregnancy.

Sponsors

Groene Hart Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Zie protocol pagina 16

Exclusion criteria

Exclusion criteria: Zie protocol pagina 16

Design outcomes

Primary

MeasureTime frame
1. Feasibility: a. Part 1. Determination of pertussis specific antibody responses and persistence in mother and child after vaccination of the mother during pregnancy. Antibody titres of women vaccinated during pregnancy will be measured and compared with data from an ongoing study on titres in pregnant women not vaccinated during the study and with data on titres of pregnant women who have recently been infected with B. pertussis. b. Part 2. Determination of transplacental transfer of different antibodies against B. pertussis and the decline of these antibodies in the infant post natal. 2. Safety: a. Part 1. Rate of adverse events in pregnant women after immunization (using the WHO criteria). b. Part 2. Rate of adverse events after immunization in infants of vaccinated mothers.

Secondary

MeasureTime frame
1. The number of infections with B. pertussis in infants and mothers after maternal vaccination until the first year after birth. 2. The course of antibody-titers in infants of vaccinated mothers will be studied before and after routine childhood vaccination. 3. Antibody-titers to diphtheria, tetanus and polio will be measured.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)