Study of Long-term Pertussis Immunity in Children at Age 4 Years Following Maternal Vaccination During Pregnancy

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What is this study about?

This clinical trial focuses on studying pertussis, also known as whooping cough, a highly contagious respiratory infection. The study aims to examine long-term differences in immunity against pertussis in children whose mothers received vaccination during pregnancy compared to those whose mothers did not.

The study involves the use of Tetravac, which is an injectable vaccine suspension that contains inactivated components to protect against multiple diseases. This combination vaccine includes protection against diphtheria, tetanus, pertussis (whooping cough), and polio. The vaccine is given as a single injection into the muscle.

The research will follow children until they reach 4 years of age, focusing on measuring their immunity levels against pertussis. The study will involve children who previously participated in an earlier phase of research when they were 6 months old. Each participant will receive a single dose of 0.5 milliliters of the vaccine.

1 Initial participation

You have previously participated in the original MIFI study and completed the 6-month timepoint.

The study focuses on pertussis immunity in children at age 48 months (4 years).

2 Study vaccination

You will receive Tetravac, which is a suspension for injection.

The vaccine contains components for protection against diphtheria, tetanus, pertussis (whooping cough), and polio.

The vaccine will be administered through an intramuscular injection (into the muscle).

3 Follow-up period

After vaccination, there will be a 28-day observation period.

During this time, your child’s immune response to the vaccine will be monitored.

The main focus is measuring the levels of antibodies against pertussis in your child’s blood.

4 Study completion

The study will compare immune responses between children whose mothers received pertussis vaccination during pregnancy and those who did not.

Your participation will contribute to understanding long-term immunity patterns in children.

The study is scheduled to end on September 30, 2024.

Who Can Join the Study?

Child must have been a participant in the original MIFI study and completed at least 6 months of that study
Child must be around 48 months (4 years) of age
Both male and female children can participate
Child must be from a family that participated in the previous study looking at pertussis immunity (pertussis is also known as whooping cough)
Child’s mother must have been involved in the original vaccination study during her pregnancy
Child must be generally healthy and able to attend study visits
Parent or legal guardian must be willing to provide informed consent for the child’s participation

Who Cannot Join the Study?

Child not aged 48 months at the time of study participation
Child’s mother did not receive vaccination status documentation during pregnancy
Known allergies to vaccine components or previous severe vaccine reactions
Compromised immune system (immunodeficiency) or taking medications that suppress the immune system
Acute illness or fever at the time of planned study procedures
Current participation in other clinical trials
Inability to comply with study visits and procedures
History of pertussis (whooping cough) infection
Receipt of blood products or immunoglobulins (antibody treatments) in the past 3 months
Any medical condition that could interfere with study results or pose risk to the participant

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Vwiajphhcngsjcgy hcnjhkwmxeyyybk	Turku	Finland

Trial status

Country	Status	Recruitment Start
Finland	Not recruiting	01.03.2024

Trial locations

Pertussis vaccine is a vaccine that helps protect against whooping cough, a highly contagious respiratory disease. In this trial, it is administered to pregnant mothers to study how the vaccination during pregnancy affects their children’s immunity to pertussis (whooping cough) over a long period. The vaccine works by stimulating the mother’s immune system to produce antibodies that can be passed to the baby before birth, potentially providing early protection against the disease.

Pertussis – A highly contagious respiratory infection caused by the Bordetella pertussis bacteria. The disease typically begins with mild cold-like symptoms, including runny nose and low-grade fever. After 1-2 weeks, severe coughing episodes develop, often characterized by a distinctive “whooping” sound when breathing in after coughing. The coughing fits can be intense enough to cause vomiting and exhaustion. The condition can affect people of any age, but it’s particularly concerning in young children and infants. The symptoms gradually improve over weeks to months, though the cough may persist for up to several months.

Trial ID:

2024-510787-23-00

Protocol code:

MIFI-4Y

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Long-term Pertussis Immunity in Children at Age 4 Years Following Maternal Vaccination During Pregnancy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?