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Maternal determinants of infant immunity to pertussis (MADI-02)
EU CTIS ID: 2024-517893-73-00
What this study is testing
The main objective of the project is to identify the determinants of antibody-mediated immunity to pertussis in infants born to mothers immunized during pregnancy. Specifically, the project aims to identify key predictors and potential determinants of vaccine responses in pregnant women, of the transfer of maternal antibodies to the newborn and of vaccine responses in infants.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- (Women) Age between 18 and 45 years
- (Women) Eligible for Tdap vaccination
- (Women) Last Pertussis vaccination > 12 months ago
- (Women) Pregnant and non-pregnant women
- (Infants) Infants of 2 months (+- 1 week) of age (boys and girls)
- (Infants) Born after 35 weeks of gestation
You likely can't join if
- (Women) Inability to understand the nature and extent of the study and the procedures required
- (Infants) Severe neonatal distress
- (Infants) Serious congenital abnormalities or congenital infection
- (Women) Grade III/IV anemia
- (Women) Acute infection at the time of immunization
- (Women) Chronic infections such as HBV, HCV or HIV infection, acute toxoplasmosis
See the full eligibility criteria
- (Women) Age between 18 and 45 years
- (Women) Eligible for Tdap vaccination
- (Women) Last Pertussis vaccination > 12 months ago
- (Women) Pregnant and non-pregnant women
- (Infants) Infants of 2 months (+- 1 week) of age (boys and girls)
- (Infants) Born after 35 weeks of gestation
- (Infants) Birthweight above 2.5 kg
- (Infants) Consent form signed by the parents
- (Women) Inability to understand the nature and extent of the study and the procedures required
- (Infants) Severe neonatal distress
- (Infants) Serious congenital abnormalities or congenital infection
- (Women) Grade III/IV anemia
- (Women) Acute infection at the time of immunization
- (Women) Chronic infections such as HBV, HCV or HIV infection, acute toxoplasmosis
- (Women) Current or recent use of immunosuppressive drugs
- (Women) Active neoplasia
- (Women) Other vaccination at the same time as pertussis vaccination (wash out of 4 weeks after other vaccinations and 28 days after Tdap vaccination)
- (Pregnant women) Risk of premature delivery or intrauterine growth retardation
- (Pregnant women) Twin or triplet pregnancies
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.