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.
Conditions
Interventions
Trade Name: Boostrix
Product Name: Boostrix
Pharmaceutical Form: Solution for injection
Sponsors
University of Antwerp
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •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
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The present study investigates the transfer of maternal pertussis antibodies, elicited by a booster vaccination (Boostrix)of women between two pregnancies. Data from both mother and siblings are compared pre- and post booster. The aim of the study is to evaluate whether a pre-pregnancy booster would help to reduce susceptibility to pertussis in neonates. What are the titres of maternal antibodies against pertussis: in women at delivery and in their neonates in cord blood and at month 1 (pre-immunization)?;Secondary Objective: -What is the influence of other factors on the duration and titre of maternal antibodies in children: age since vaccination, demographic data etc. -Comparison of the two kinetics of the maternal antibody transfer to children of the same mother whether she was vaccinated or not against pertussis after the previous pregnancy. -Comparison of immunogenicity on routine pertussis vaccine in both groups of children (age 6-9-12 months) ;Primary end point(s): - descibe titres of maternal antibodies against pertussis: in women at delivery and in their neonates in cord blood and at month 1 (pre-immunization) - descibe influence on the amount of maternal antibodies transferred to the following child, when the mother is vaccinated against pertussis with Boostrix® after a previous delivery - descibe influence of other factors on the duration and titre of maternal antibodies in children: age since vaccination, demographic data etc. - Comparison of the two kinetics of the maternal antibody transfer to children of the same mother whether she was vaccinated or not against pertussis after the previous pregnancy. - Comparison of immunogenicity on routine pertussis vaccine in both groups of children (age 6-9-12 months) | — |
Countries
Belgium
Outcome results
None listed