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HAEMOPHILUS INFLUENZAE TYPE B POLYRIBOSYLRIBITOL PHOSPHATE CONJUGATED TO MENINGOCOCCAL PROTEIN ADSORBED ON AMORPHOUS ALUMINIUM HYDROXYPHOSPHATE SULFATE

Clinical trials are investigating HAEMOPHILUS INFLUENZAE TYPE B POLYRIBOSYLRIBITOL PHOSPHATE CONJUGATED TO MENINGOCOCCAL PROTEIN ADSORBED ON AMORPHOUS ALUMINIUM HYDROXYPHOSPHATE SULFATE as part of a vaccine study in pregnancy and infancy. The trial looks at immune response, antibody transfer from mother to baby, and how infants respond after maternal vaccination. The target population is pregnant women and their infants.

Table of Contents

Trial overview

This article covers one interventional study of HAEMOPHILUS INFLUENZAE TYPE B POLYRIBOSYLRIBITOL PHOSPHATE CONJUGATED TO MENINGOCOCCAL PROTEIN ADSORBED ON AMORPHOUS ALUMINIUM HYDROXYPHOSPHATE SULFATE that was designed around maternal and infant immunity to pertussis (whooping cough).[1] The study was completed and enrolled 240 participants.[1]

Who can participate

The target population was pregnant women, with follow-up of their infants after birth.[1] The brief summary says the project aimed to study infants born to mothers immunized during pregnancy, so both the mother and baby were part of the research question.[1]

What is being measured

The primary outcome was the magnitude of the antibody responses to pertussis vaccination.[1] In simple terms, the researchers measured how strong the immune response was after vaccination.[1]

The brief summary also states that the study aimed to identify predictors and potential determinants of vaccine responses in pregnant women, the transfer of maternal antibodies to the newborn, and vaccine responses in infants.[1] A predictor is a factor that may help explain or forecast a result.[1]

Study phase and design

This was a Phase 3 trial.[1] Phase 3 studies are later-stage clinical trials and are often used to better understand how an intervention performs in a larger group.[1]

The study type was interventional, which means the researchers assigned study vaccines and then measured the immune results.[1] The interventions listed were Vaxelis and Triaxis, both given by intramuscular injection.[1]

Results focus on immunity

The main scientific focus was not on symptoms, but on immune protection and antibody transfer between mother and baby.[1] This makes the trial important for understanding how vaccination during pregnancy may affect both maternal and infant immune responses.[1]

Key points for patients

This trial studied whooping cough immunity in pregnancy and infancy, with a special focus on antibodies.[1] It included pregnant women and their infants, was in Phase 3, and ended as a completed study with 240 participants.[1] The main outcome was the strength of the antibody response to pertussis vaccination.[1]

Trial ID Phase Condition studied Status Enrollment
NCT05856396 Phase 3 Whooping cough Completed 240

FAQ

  • Who can take part in these clinical trials? The trial includes pregnant women and then follows their infants after birth. It studies mothers immunized during pregnancy and the babies born to them.
  • What is being studied in the trial? The study is looking at antibody response to pertussis vaccination, which means the body’s immune response to whooping cough vaccine. It also studies how maternal antibodies are passed to the newborn and how infants respond later.
  • What phase is the trial? This trial is a Phase 3 study. Phase 3 trials are larger studies that help researchers understand how well an intervention works in a specific group.
  • What condition is the trial focused on? The trial focuses on whooping cough, also called pertussis. It is studying immune protection related to this infection.
  • What is the main outcome being measured? The main outcome is the magnitude of the antibody responses to pertussis vaccination. In simple terms, this means how strong the immune response is after vaccination.

Ongoing Clinical Trials on HAEMOPHILUS INFLUENZAE TYPE B POLYRIBOSYLRIBITOL PHOSPHATE CONJUGATED TO MENINGOCOCCAL PROTEIN ADSORBED ON AMORPHOUS ALUMINIUM HYDROXYPHOSPHATE SULFATE

  • Study on How Vaccines Affect Infant Immunity to Whooping Cough in Babies Born to Vaccinated Mothers Using Diphtheria, Tetanus, and Pertussis Vaccine Combination

    Not recruiting

    3 1 1 1
    Investigated drugs:
    Belgium

Glossary

  • Antibody: A protein made by the immune system to help protect the body from infection.
  • Antibody response: The amount or strength of antibodies the body makes after vaccination or infection.
  • Maternal immunity: Protection passed from a mother to her baby, often through antibodies during pregnancy.
  • Transfer of maternal antibodies: The movement of antibodies from the mother to the newborn before birth.
  • Newborn: A baby soon after birth.
  • Pertussis: Another name for whooping cough, a contagious illness that affects the lungs and airways.
  • Phase 3: A later stage of clinical research that usually includes more participants and helps measure how well a study intervention works.
  • Interventional study: A trial where researchers give a study intervention and then measure the results.
  • Primary outcome: The main result the researchers plan to measure in a trial.
  • Pregnancy immunization: Vaccination given during pregnancy to study protection for the mother and baby.

References