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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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 trial?

7 criteria

  • 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 trial?

10 criteria

  • 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
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Investigated drugs

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.

What is already known about the treatment

Pertussis vaccine - An immunization product administered via intramuscular injection that helps prevent whooping cough (pertussis) infection. This vaccine belongs to the class of inactivated bacterial vaccines and works by stimulating the immune system to produce antibodies against Bordetella pertussis bacteria. The vaccine is particularly important in maternal immunization programs, where it's given during pregnancy to provide protection to both the mother and developing baby through antibody transfer. Currently, it's widely recognized in medical practice as a crucial tool for preventing severe pertussis infections, especially in infants and young children, with extensive clinical evidence supporting its safety and effectiveness.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510787-23-00Protocol codeMIFI-4YEstimated enrolment138 patientsSponsorVarsinais-Suomen hyvinvointialue

sourced from the EU Clinical Trials Register and site verification

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