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

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What is this study about?

This clinical trial is focused on understanding how babies develop immunity to whooping cough, a contagious respiratory disease known for severe coughing fits. The study involves two vaccines: Vaxelis and Triaxis. Vaxelis is a combination vaccine that protects against several diseases, including diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis, and Haemophilus influenzae type b. Triaxis is a vaccine that targets diphtheria, tetanus, and pertussis with a reduced antigen content.

The purpose of the study is to identify factors that influence how well infants develop immunity to whooping cough when their mothers are vaccinated during pregnancy. The study will look at how antibodies, which are proteins in the blood that fight infections, are transferred from the mother to the baby and how the baby’s immune system responds to the vaccines. Pregnant women will receive the Tdap vaccine, which is a booster shot for tetanus, diphtheria, and pertussis, to help protect their newborns from whooping cough.

Participants in the study will include pregnant women and their infants. The study will follow the infants from birth to see how their immune systems respond to the vaccines. The research aims to provide valuable insights into how maternal vaccination can protect infants from whooping cough and improve vaccine strategies for better infant health outcomes.

1 joining the study

Upon joining the study, participants will be informed about the purpose and procedures of the trial. Consent forms must be signed by the parents of infants participating in the study.

2 initial assessment

Participants will undergo an initial assessment to confirm eligibility. This includes verifying age, vaccination history, and other criteria for both mothers and infants.

3 vaccination

Eligible pregnant women will receive a Tdap vaccination to help protect against whooping cough. The vaccine is administered as an intramuscular injection.

4 infant assessment

Infants will be assessed at approximately 2 months of age. This includes checking their health status and confirming they meet the study criteria, such as birth weight and gestational age.

5 monitoring and follow-up

Participants will be monitored throughout the study to evaluate the antibody responses to the pertussis vaccination. This involves regular check-ups and possibly additional blood tests to measure immune responses.

6 completion of study

The study is expected to conclude by the end of 2025. Participants will be informed about the outcomes and any relevant findings related to the study objectives.

Who Can Join the Study?

Women aged between 18 and 45 years.
Women who are eligible for the Tdap vaccination. (Tdap is a vaccine that protects against tetanus, diphtheria, and pertussis, which is also known as whooping cough.)
Women whose last pertussis (whooping cough) vaccination was more than 12 months ago.
Women who are either pregnant or not pregnant.
Infants who are 2 months old, with a margin of plus or minus 1 week. This includes both boys and girls.
Infants who were born after 35 weeks of pregnancy.
Infants who have a birth weight above 2.5 kg (about 5.5 pounds).
Infants whose parents have signed a consent form, giving permission for their participation in the study.

Who Cannot Join the Study?

Participants cannot have a history of severe allergic reactions to any vaccine.
Participants should not have any ongoing infections or illnesses at the time of the study.
Participants must not be taking medications that suppress the immune system, which are drugs that lower the body’s ability to fight infections.
Participants should not have any chronic illnesses that are not well-controlled, meaning their condition is not stable or managed effectively with treatment.
Participants must not be pregnant or planning to become pregnant during the study, unless the study specifically involves pregnant women.
Participants should not have received any other vaccines within a certain period before the study, as specified by the study guidelines.
Participants must not have participated in another clinical trial recently, as this could affect the study results.
Participants should not have any known immune system disorders, which are conditions where the immune system does not work properly.
Participants must not have any history of drug or alcohol abuse, which could interfere with the study results.
Participants should not have any mental health conditions that could affect their ability to understand or follow the study procedures.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
CHU Saint Pierre	Brussels	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.09.2023

Trial locations

Investigated drugs:

Maternal Pertussis Vaccine
This vaccine is given to pregnant women to help protect their babies from pertussis, also known as whooping cough. When a mother receives this vaccine during pregnancy, her body produces antibodies that can be passed to the baby before birth. These antibodies help protect the newborn from pertussis in the first few months of life, before the baby is old enough to receive their own vaccinations. The goal of this vaccine in the trial is to study how well these antibodies are transferred from the mother to the baby and how they help in protecting the baby against pertussis.

Pertussis – Pertussis, also known as whooping cough, is a highly contagious respiratory disease caused by the bacterium Bordetella pertussis. It begins with symptoms similar to a common cold, such as a runny nose, mild cough, and fever. As the disease progresses, severe coughing fits develop, which can produce a high-pitched “whoop” sound when the person breathes in. These coughing spells can lead to vomiting and exhaustion. The disease is particularly severe in infants and young children, who may experience complications such as pneumonia. Pertussis spreads through respiratory droplets when an infected person coughs or sneezes.

Trial ID:

2024-517893-73-00

NCT ID:

NCT05856396

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?