E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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)? |
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E.2.2 | Secondary objectives of the trial |
-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)
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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)
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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end of trial: blood sample taken at the age of 12 months in the last born child. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |