Table of contents
- Overview of the clinical trial
- Who was studied
- Study design and phase
- Main outcome measured
- What the study tried to learn
Overview of the clinical trial
The available trial data describe an interventional study that included HEPATITIS B SURFACE ANTIGEN (RDNA) ADSORBED ON AMORPHOUS ALUMINIUM HYDROXYPHOSPHATE SULPHATE [PRODUCED IN S. CEREVISIAE BY RDNA] as part of a vaccination strategy during pregnancy.[1] The study focused on whooping cough and looked at how vaccination in pregnancy may affect immunity in infants.[1]
Who was studied
The target population was pregnant women and their newborn infants.[1] The brief summary says the project aimed to identify predictors of vaccine responses in pregnant women, the transfer of maternal antibodies to the newborn, and vaccine responses in infants.[1]
Study design and phase
This was an interventional study, which means the research team gave a vaccine intervention and then measured the results.[1] The trial was in Phase 3 and had an enrollment of 240 participants.[1] Its status is listed as Completed.[1]
Main outcome measured
The primary outcome was the magnitude of the antibody responses to pertussis vaccination.[1] In simple words, the study measured how strong the immune response was after vaccination.[1]
What the study tried to learn
The study aimed to understand the main factors that shape antibody-based immunity in infants born to mothers vaccinated during pregnancy.[1] It also looked at the response in the mother, the movement of antibodies from mother to baby, and the baby’s own response after birth.[1]
For patients, the key point is that this trial was not mainly about treating an illness in the usual sense; it was about learning how vaccination in pregnancy may help protect the baby early in life.[1] The study data provided here do not include extra details about other endpoints beyond the primary antibody outcome.[1]
