Table of contents
- Trial overview
- Who participated
- What was studied
- Outcomes measured
- Study design and phase
- Patient-friendly terms
Trial overview
The trial provided in the source data is NCT05856396, titled Maternal determinants of infant immunity to pertussis (MADI-02). It is a completed Phase 3 interventional study with 240 participants and focuses on whooping cough, also called pertussis.[1]
The brief summary says the main goal was to identify the determinants of antibody-mediated immunity to pertussis in infants born to mothers immunized during pregnancy.[1] In simple words, the researchers wanted to learn what factors affect how well the immune response works in mothers and babies.[1]
Who participated
The study focused on pregnant women who were immunized during pregnancy and the infants born to them.[1] This means the trial was not only about the mother’s response, but also about how the baby may benefit from antibodies passed before birth.[1]
The enrollment was 240 people.[1] The source does not give more detailed eligibility rules, so the article can only state that the study involved pregnant women and their newborns or infants.[1]
What was studied
The study examined the immune response after vaccination, with a focus on antibody-mediated immunity.[1] Antibodies are proteins made by the immune system that help protect against infection.[1]
The brief summary says the project aimed to identify key predictors and potential determinants of vaccine responses in pregnant women, the transfer of maternal antibodies to the newborn, and vaccine responses in infants.[1] This means the trial looked at both the mother’s immune response and the baby’s early protection.[1]
The interventions listed in the source include Vaxelis suspension for injection in pre-filled syringe and Triaxis suspension injectable en seringue préremplie, both described with pertussis-containing vaccines.[1] The source also names HEPATITIS B SURFACE ANTIGEN (RDNA) ADSORBED ON AMORPHOUS ALUMINIUM HYDROXYPHOSPHATE SULPHATE [PRODUCED IN S. CEREVISIAE BY RDNA] as part of the vaccine composition in Vaxelis.[1]
Outcomes measured
The primary outcome was the magnitude of the antibody responses to pertussis vaccination.[1] “Magnitude” means how strong or large the response is.[1]
This outcome helps researchers judge whether vaccination during pregnancy leads to a strong immune response in the mother and whether that response may support protection in the infant.[1] The summary also shows that the study was designed to explore predictors of response, transfer of antibodies, and infant vaccine response.[1]
Study design and phase
This was an interventional study, meaning researchers gave a vaccine and then observed what happened.[1] It was conducted in Phase 3, which is a later stage of clinical research used to study effects in a larger group of people.[1]
The status of the trial is Completed.[1] The source does not provide results data, so only the trial design and planned measurements can be described here.[1]
Patient-friendly terms
Whooping cough, or pertussis, is the disease being studied in this trial.[1] It is important because the study looks at whether vaccination during pregnancy can help protect both mother and baby.[1]
Maternal antibodies are antibodies from the mother that can pass to the baby before birth.[1] Researchers studied this transfer because it may give the baby early protection while their own immune system is still developing.[1]
Predictors and determinants are factors that may help explain why some people respond better to a vaccine than others.[1] In this trial, the researchers tried to find those factors in pregnant women and infants.[1]
